<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989597</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6985</org_study_id>
    <nct_id>NCT02989597</nct_id>
  </id_info>
  <brief_title>Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients</brief_title>
  <acronym>MAPS</acronym>
  <official_title>Single-dose Intraoperative Methadone for Early Ambulation and Sustained Pain Control in Spinal Fusion Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Methadone has several advantages over standard narcotic medications, especially when&#xD;
      considering use after a typically painful surgery such as lumbar fusion. Methadone is low&#xD;
      cost, has a long half-life, has a convenient dosing schedule, has excellent oral&#xD;
      bioavailability, and demonstrates slow onset to withdrawal. The literature comparing&#xD;
      methadone to more commonly used post-operative narcotics demonstrates that it manages pain&#xD;
      better, sustains consistent plasma concentrations, decreases overall narcotic requirement,&#xD;
      results in no additional adverse events, and is safe, even in children, across several&#xD;
      studies. Since the standard of care is non-methadone narcotic usage to manage the significant&#xD;
      pain of complex spinal surgery cases, it is understandable that methadone could be a&#xD;
      desirable alternative to promote sustained pain control and early ambulation in these&#xD;
      patients. The goal of this study is to compare the effect of a single dose of methadone&#xD;
      administered intraoperatively in enrolled spinal fusion patients to their historical controls&#xD;
      given fentanyl and morphine, and determine if more sustained pain control during the first&#xD;
      few days after surgery provides a better subjective experience for the patient with less&#xD;
      pain, which allows them to ambulate and leave the hospital sooner than patients given a&#xD;
      standard regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methadone is a synthetic opioid analgesic with agonist properties at the µ-opioid receptor&#xD;
      binding site that has long been used as an alternative to morphine and hydromorphone in&#xD;
      patients with severe pain. It has a diffuse bioavailability and is highly efficacious through&#xD;
      its oral form, yet its bioavailability is heavily dependent on variability in cytochrome P450&#xD;
      3A4 enzyme activity, and is quite variable amongst individuals. Methadone reaches peak plasma&#xD;
      concentrations in 2.5 to 4 hours after oral administration, has a rapid onset, has a&#xD;
      half-life is between 20-35 hours (range 5-130 hours), and analgesia may be reported for up to&#xD;
      108 hours after a single dose. Additionally, methadone's NMDA (N-methyl-D-aspartate) receptor&#xD;
      site antagonism acts to inhibit enzymes such as adenyl cyclase and their downstream&#xD;
      production of secondary signaling molecules like cyclic AMP (adenosine monophosphate). This&#xD;
      activity may attenuate opioid tolerance and opioid abstinence syndrome as NMDA receptor&#xD;
      agonism has been implicated in the development of hyperalgesia, acute and chronic tolerance,&#xD;
      and chronic pain states.&#xD;
&#xD;
      IV dosing typically ranges from 2.5mg to 10mg every 8-12 hours, with PO forms dosed at 5-20mg&#xD;
      every 6-8 hours.&#xD;
&#xD;
      In a study of surgical patients, 40% required no additional post-operative pain control after&#xD;
      a single 20mg iv methadone dose intra-operatively, and the 35% that did require a single&#xD;
      additional dose required it on average 18.4±6.6 hours post-operatively. The remainder&#xD;
      received additional non-narcotic pain medications post-operatively which were sufficient to&#xD;
      control pain to tolerable levels.&#xD;
&#xD;
      In a series of 29 patients undergoing multilevel thoracolumbar spine surgeries with&#xD;
      instrumentation and fusion, patients were randomized to receive either methadone (0.2mg/kg)&#xD;
      or sufentanil infusion of 0.25µg/kg/h after a load of 0.75 µg/kg.Post-operative pain control&#xD;
      was delivered by patient-controlled analgesia and patients were assessed by visual analogue&#xD;
      scale for pain, opioid dose, and side effected at 1, 2, and 3 days post-operatively. Patients&#xD;
      reported less pain in the methadone group 48 hours post-operatively, as well as used less&#xD;
      cumulative narcotic dose than the remifentanil control group. Side effects were not&#xD;
      significantly different between the two groups. This study however, did not evaluate&#xD;
      post-operative functional status, ambulation, and time to discharge.&#xD;
&#xD;
      The literature comparing methadone to more commonly used post-operative narcotics&#xD;
      demonstrates that it manages pain better, decreases narcotic requirement, results in no&#xD;
      additional adverse events, and is safe, even in children. Since the standard of care is&#xD;
      narcotic usage to manage the significant pain of complex spinal surgery cases, it is&#xD;
      understandable that methadone could be a desirable therapy to promote sustained pain control&#xD;
      and early ambulation in these patients.&#xD;
&#xD;
      The current hypothesis is that methadone use intra-operatively will result in earlier time to&#xD;
      ambulate post op and better ability to participate with post-operative physical therapy&#xD;
      evaluation, lower narcotic usage, and earlier discharge. It is also foreseeable that since&#xD;
      methadone would be administered while the patient was sedated intra-operatively, it could&#xD;
      prevent the association between the analgesia and euphoria that may result from self- or&#xD;
      nurse-administered narcotics, such as with a patient-controlled analgesia (PCA), which could&#xD;
      promote early tolerance or reliance. The study plans to enroll the first 30 consecutive&#xD;
      patients who met inclusion criteria, with an end goal of 20 patients who will complete the&#xD;
      study. Patient will be recruited in office at time of consent for surgery by the principal&#xD;
      investigator and be scheduled to undergo 1 or 2 level lumbar decompression and fusion&#xD;
      surgery.&#xD;
&#xD;
      The study outlined will be a prospective, positive-control, triple-blinded study in which the&#xD;
      patient, care providers, and investigators will be unaware of the randomization of the&#xD;
      patients. Only the anesthesiologist treating the patient during surgery will be aware of the&#xD;
      administration of methadone or not.&#xD;
&#xD;
      On the day of surgery, the patient's pre-operative pain and functional status will be&#xD;
      assessed, in addition to a review of the study protocols. An anesthesiologist will be&#xD;
      assigned to the case and will administer a 0.2 mg/kg single-dose administration of methadone&#xD;
      on incision (not to exceed 20 mg, as used in the literature) with a ketamine infusion of 4&#xD;
      µg/kg/min and a remifentanil infusion starting at 0.1 µg/kg/min and titrating to effect or&#xD;
      sufentanil infusion starting with a dose of 0.3 µg/kg/hr and titrating to effect. These&#xD;
      standard doses have been well documented and studied in the literature and will be overseen&#xD;
      and have been approved by Board certified anesthesiologist. For lengthier procedures, there&#xD;
      will not be re-dosing of narcotics toward the end of the procedure. The operative procedure&#xD;
      will not be altered in any way for the purposes of this study, and is beyond the scope of&#xD;
      this protocol, yet can be detailed as requested. The patient will be taken to the recovery&#xD;
      room post-operative and will be put on a standard post-operative morphine PCA at a rate of&#xD;
      1mg per 6 minute lock-out period. Patient's narcotic usage and pain rating will be recorded&#xD;
      at the intervals listed above and when stable from a cardiovascular standpoint, will be&#xD;
      transition to the neurosurgery floor. Once able to bare weight, the patient will be&#xD;
      encouraged to work with physical and occupational therapy as per standard post-operative&#xD;
      protocol. Once the patient uses the PCA at a rate of less that once an hour, and can be&#xD;
      managed with oral pain medications, the PCA will be removed. The remainder of their&#xD;
      post-operative care will be according to the standard departmental protocol, and when&#xD;
      milestones such as ambulation, voiding, and pain control are met, they will be discharged&#xD;
      either to home, an acute care facility, or a subacute rehabilitation center. Any adverse&#xD;
      events/reactions will be recorded and managed as normally they would be, and naloxone will be&#xD;
      available for suspicion of narcotic overdose The subjects of this study will be compared to&#xD;
      the historical controls in demonstrating the effect of methadone on post-operative pain,&#xD;
      medication usage, and rehabilitation time. A goal of 30 patients will be planned to be&#xD;
      enrolled. Other than intra-operative narcotic administration, all other portions of the&#xD;
      intra-operative and post-operative care will remain the same as for historical patients.&#xD;
&#xD;
      The primary outcomes for the study include total narcotic dose post-operative, frequency of&#xD;
      narcotic use, the time to first ambulation after surgery with physical therapy, length of&#xD;
      stay, and disposition (i.e. level of rehabilitative care). Secondary outcomes include better&#xD;
      subjective pain control, need for post-operative course of dexamethasone for&#xD;
      post-operative/post-fusion radiculopathy or neurapraxia/neuropathy, and fusion at 3-6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to personnel loss and logistical issues the study was unable to be completed as planned.&#xD;
  </why_stopped>
  <start_date type="Actual">July 29, 2017</start_date>
  <completion_date type="Actual">November 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>Preoperatively</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>8 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>16 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>20 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>28 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>32 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>36 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>40 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>44 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>52 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>56 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>60 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>64 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>68 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>76 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>80 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>84 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>88 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>92 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Health-related Quality of Life (SF-36)</measure>
    <time_frame>96 hours after surgery</time_frame>
    <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to First Ambulation</measure>
    <time_frame>Immediately postoperatively until ambulation, on average 3-4 days</time_frame>
    <description>Unit: days. Assessments of patients' time to first ambulation post-operatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Discharge From Hospital</measure>
    <time_frame>Immediately postoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
    <description>Unit: days. Measured at patient discharge (=length of stay)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Narcotic Dose in the Hospital</measure>
    <time_frame>Intraoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
    <description>Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Narcotic Usage</measure>
    <time_frame>Intraoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
    <description>Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Disposition at Discharge</measure>
    <time_frame>At patient discharge, on average 1 week, up to 1 month</time_frame>
    <description>Level of rehabilitative care deemed to be required (upon patient discharge)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Course of Dexamethasone</measure>
    <time_frame>Intraoperatively through patient discharge, on average 1 week, up to 1 month</time_frame>
    <description>Binary assessment of need for post-operative course of Dexamethasone for post-operative/post-fusion radiculopathy or neurapraxia/neuropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Lumbar Fusion</measure>
    <time_frame>3-6 months</time_frame>
    <description>Confirmation of successful fusion of lumbar vertebrae</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients administered standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methadone Hydrochloride</intervention_name>
    <description>IV administration of methadone intra-operatively for a single dose</description>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard pain regimen</intervention_name>
    <description>Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Fusion Surgery</intervention_name>
    <description>Clinically-indicated spinal fusion surgery</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Post operative swelling and pain control</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Perioperative anesthesia medication</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Perioperative pain medication</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>Perioperative pain medication</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intra-operative Methadone Hydrochloride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets age criteria, age between 18-80&#xD;
&#xD;
          -  Undergoing lumbar fusion surgery, one or two spinal levels&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) grades I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient outside of age criteria&#xD;
&#xD;
          -  Renal failure requiring dialysis&#xD;
&#xD;
          -  Serum creatinine greater than 2.0&#xD;
&#xD;
          -  Hepatic dysfunction with liver function tests greater than twice the upper limit&#xD;
&#xD;
          -  Pulmonary disease requiring home oxygen therapy&#xD;
&#xD;
          -  Obstructive sleep apnea&#xD;
&#xD;
          -  Severe heart disease&#xD;
&#xD;
          -  Allergy to methadone, morphine, or fentanyl&#xD;
&#xD;
          -  Recent or distant history of opioid abuse&#xD;
&#xD;
          -  Poorly managed psychiatric illness&#xD;
&#xD;
          -  Known history of alcohol abuse&#xD;
&#xD;
          -  Morbid obesity (body mass index &gt; 50 kg/m2)&#xD;
&#xD;
          -  Treatment with other NMDA receptor antagonists&#xD;
&#xD;
          -  Prolonged QTc (corrected QT interval) on pre-operative EKG,&#xD;
&#xD;
          -  Refusal or inability to sign the consent form&#xD;
&#xD;
          -  Current use of HIV-1 protease inhibitors, erythromycin, ketoconazole, rifabutin,&#xD;
             carbamazepine, phenytoin, phenobarbital, St. John's Wort, fluconazole, fluvoxamine,&#xD;
             fluoxetine, paroxetine&#xD;
&#xD;
          -  Grapefruit juice intake within the last week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew J Kobets, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Merritt D Kinon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Inturrisi CE. Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):435-7.</citation>
    <PMID>16012416</PMID>
  </reference>
  <reference>
    <citation>Lugo RA, Satterfield KL, Kern SE. Pharmacokinetics of methadone. J Pain Palliat Care Pharmacother. 2005;19(4):13-24.</citation>
    <PMID>16431829</PMID>
  </reference>
  <reference>
    <citation>Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14.</citation>
    <PMID>22978825</PMID>
  </reference>
  <reference>
    <citation>Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.</citation>
    <PMID>22037641</PMID>
  </reference>
  <reference>
    <citation>Pacreu S, Fernandez Candil J, Molto L, Carazo J, Fernandez Galinski S. The perioperative combination of methadone and ketamine reduces post-operative opioid usage compared with methadone alone. Acta Anaesthesiol Scand. 2012 Nov;56(10):1250-6. doi: 10.1111/j.1399-6576.2012.02743.x. Epub 2012 Jul 26.</citation>
    <PMID>22834921</PMID>
  </reference>
  <reference>
    <citation>Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.</citation>
    <PMID>25837528</PMID>
  </reference>
  <reference>
    <citation>Jacobson L, Chabal C, Brody MC, Ward RJ, Ireton RC. Intrathecal methadone and morphine for postoperative analgesia: a comparison of the efficacy, duration, and side effects. Anesthesiology. 1989 May;70(5):742-6. doi: 10.1097/00000542-198905000-00005.</citation>
    <PMID>2655501</PMID>
  </reference>
  <reference>
    <citation>Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.</citation>
    <PMID>6742480</PMID>
  </reference>
  <reference>
    <citation>Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.</citation>
    <PMID>20418538</PMID>
  </reference>
  <reference>
    <citation>Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.</citation>
    <PMID>22063370</PMID>
  </reference>
  <reference>
    <citation>Russell T, Mitchell C, Paech MJ, Pavy T. Efficacy and safety of intraoperative intravenous methadone during general anaesthesia for caesarean delivery: a retrospective case-control study. Int J Obstet Anesth. 2013 Jan;22(1):47-51. doi: 10.1016/j.ijoa.2012.10.007. Epub 2012 Dec 7.</citation>
    <PMID>23219678</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>March 2, 2023</results_first_submitted>
  <results_first_submitted_qc>April 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 25, 2023</results_first_posted>
  <disposition_first_submitted>January 20, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>February 12, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 15, 2022</disposition_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Methadone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02989597/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intra-operative Methadone Hydrochloride</title>
          <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intra-operative Methadone Hydrochloride</title>
          <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>Preoperatively</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>4 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>8 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>12 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>16 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>20 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>24 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>28 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>32 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>36 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>40 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>44 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>48 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>52 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>56 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>60 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>64 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>68 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>72 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>76 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>80 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>84 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>88 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>92 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Health-related Quality of Life (SF-36)</title>
        <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>96 hours after surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Health-related Quality of Life (SF-36)</title>
          <description>The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to First Ambulation</title>
        <description>Unit: days. Assessments of patients' time to first ambulation post-operatively</description>
        <time_frame>Immediately postoperatively until ambulation, on average 3-4 days</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Ambulation</title>
          <description>Unit: days. Assessments of patients' time to first ambulation post-operatively</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Discharge From Hospital</title>
        <description>Unit: days. Measured at patient discharge (=length of stay)</description>
        <time_frame>Immediately postoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Discharge From Hospital</title>
          <description>Unit: days. Measured at patient discharge (=length of stay)</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Narcotic Dose in the Hospital</title>
        <description>Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)</description>
        <time_frame>Intraoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Total Narcotic Dose in the Hospital</title>
          <description>Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Narcotic Usage</title>
        <description>Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)</description>
        <time_frame>Intraoperatively until patient discharge, on average 1 week, up to 1 month</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Narcotic Usage</title>
          <description>Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Disposition at Discharge</title>
        <description>Level of rehabilitative care deemed to be required (upon patient discharge)</description>
        <time_frame>At patient discharge, on average 1 week, up to 1 month</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Disposition at Discharge</title>
          <description>Level of rehabilitative care deemed to be required (upon patient discharge)</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Course of Dexamethasone</title>
        <description>Binary assessment of need for post-operative course of Dexamethasone for post-operative/post-fusion radiculopathy or neurapraxia/neuropathy</description>
        <time_frame>Intraoperatively through patient discharge, on average 1 week, up to 1 month</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Course of Dexamethasone</title>
          <description>Binary assessment of need for post-operative course of Dexamethasone for post-operative/post-fusion radiculopathy or neurapraxia/neuropathy</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Lumbar Fusion</title>
        <description>Confirmation of successful fusion of lumbar vertebrae</description>
        <time_frame>3-6 months</time_frame>
        <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Intra-operative Methadone Hydrochloride</title>
            <description>Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Lumbar Fusion</title>
          <description>Confirmation of successful fusion of lumbar vertebrae</description>
          <population>Data were not collected/aggregated and, as such, no data analysis was conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Intraoperatively through patient discharge, on average 1 week, up to 1 month</time_frame>
      <desc>Risks of using any opioid narcotic, were monitored along with psychological risks, especially in opioid-naive patients. For patients in the methadone group, if the methadone intervention contributed greater than normal adverse events (&gt;2 patients) the study would have been held from further recruitment. If this adverse event was found to have been caused by the methadone administration, the trial would have stopped.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intra-operative Methadone Hydrochloride</title>
          <description>Patients who will be given a single dose of intra-operative methadone, and having standard care otherwise&#xD;
Methadone Hydrochloride: IV administration of methadone intra-operatively for a single dose&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Patients administered standard of care&#xD;
Standard pain regimen: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine&#xD;
Spinal Fusion Surgery: Clinically-indicated spinal fusion surgery&#xD;
Dexamethasone: Post operative swelling and pain control&#xD;
Ketamine: Perioperative anesthesia medication&#xD;
Remifentanil: Perioperative pain medication&#xD;
Sufentanil: Perioperative pain medication</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Andrew J. Kobets</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>718-920-7400</phone>
      <email>akobets@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989597
org study id: 2016-6985
nct id: NCT02989597
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Methadone has several advantages over standard narcotic medications, especially when
      considering use after a typically painful surgery such as lumbar fusion. Methadone is low
      cost, has a long half-life, has a convenient dosing schedule, has excellent oral
      bioavailability, and demonstrates slow onset to withdrawal. The literature comparing
      methadone to more commonly used post-operative narcotics demonstrates that it manages pain
      better, sustains consistent plasma concentrations, decreases overall narcotic requirement,
      results in no additional adverse events, and is safe, even in children, across several
      studies. Since the standard of care is non-methadone narcotic usage to manage the significant
      pain of complex spinal surgery cases, it is understandable that methadone could be a
      desirable alternative to promote sustained pain control and early ambulation in these
      patients. The goal of this study is to compare the effect of a single dose of methadone
      administered intraoperatively in enrolled spinal fusion patients to their historical controls
      given fentanyl and morphine, and determine if more sustained pain control during the first
      few days after surgery provides a better subjective experience for the patient with less
      pain, which allows them to ambulate and leave the hospital sooner than patients given a
      standard regimen.
Methadone is a synthetic opioid analgesic with agonist properties at the µ-opioid receptor
      binding site that has long been used as an alternative to morphine and hydromorphone in
      patients with severe pain. It has a diffuse bioavailability and is highly efficacious through
      its oral form, yet its bioavailability is heavily dependent on variability in cytochrome P450
      3A4 enzyme activity, and is quite variable amongst individuals. Methadone reaches peak plasma
      concentrations in 2.5 to 4 hours after oral administration, has a rapid onset, has a
      half-life is between 20-35 hours (range 5-130 hours), and analgesia may be reported for up to
      108 hours after a single dose. Additionally, methadone's NMDA (N-methyl-D-aspartate) receptor
      site antagonism acts to inhibit enzymes such as adenyl cyclase and their downstream
      production of secondary signaling molecules like cyclic AMP (adenosine monophosphate). This
      activity may attenuate opioid tolerance and opioid abstinence syndrome as NMDA receptor
      agonism has been implicated in the development of hyperalgesia, acute and chronic tolerance,
      and chronic pain states.

      IV dosing typically ranges from 2.5mg to 10mg every 8-12 hours, with PO forms dosed at 5-20mg
      every 6-8 hours.

      In a study of surgical patients, 40% required no additional post-operative pain control after
      a single 20mg iv methadone dose intra-operatively, and the 35% that did require a single
      additional dose required it on average 18.4±6.6 hours post-operatively. The remainder
      received additional non-narcotic pain medications post-operatively which were sufficient to
      control pain to tolerable levels.

      In a series of 29 patients undergoing multilevel thoracolumbar spine surgeries with
      instrumentation and fusion, patients were randomized to receive either methadone (0.2mg/kg)
      or sufentanil infusion of 0.25µg/kg/h after a load of 0.75 µg/kg.Post-operative pain control
      was delivered by patient-controlled analgesia and patients were assessed by visual analogue
      scale for pain, opioid dose, and side effected at 1, 2, and 3 days post-operatively. Patients
      reported less pain in the methadone group 48 hours post-operatively, as well as used less
      cumulative narcotic dose than the remifentanil control group. Side effects were not
      significantly different between the two groups. This study however, did not evaluate
      post-operative functional status, ambulation, and time to discharge.

      The literature comparing methadone to more commonly used post-operative narcotics
      demonstrates that it manages pain better, decreases narcotic requirement, results in no
      additional adverse events, and is safe, even in children. Since the standard of care is
      narcotic usage to manage the significant pain of complex spinal surgery cases, it is
      understandable that methadone could be a desirable therapy to promote sustained pain control
      and early ambulation in these patients.

      The current hypothesis is that methadone use intra-operatively will result in earlier time to
      ambulate post op and better ability to participate with post-operative physical therapy
      evaluation, lower narcotic usage, and earlier discharge. It is also foreseeable that since
      methadone would be administered while the patient was sedated intra-operatively, it could
      prevent the association between the analgesia and euphoria that may result from self- or
      nurse-administered narcotics, such as with a patient-controlled analgesia (PCA), which could
      promote early tolerance or reliance. The study plans to enroll the first 30 consecutive
      patients who met inclusion criteria, with an end goal of 20 patients who will complete the
      study. Patient will be recruited in office at time of consent for surgery by the principal
      investigator and be scheduled to undergo 1 or 2 level lumbar decompression and fusion
      surgery.

      The study outlined will be a prospective, positive-control, triple-blinded study in which the
      patient, care providers, and investigators will be unaware of the randomization of the
      patients. Only the anesthesiologist treating the patient during surgery will be aware of the
      administration of methadone or not.

      On the day of surgery, the patient's pre-operative pain and functional status will be
      assessed, in addition to a review of the study protocols. An anesthesiologist will be
      assigned to the case and will administer a 0.2 mg/kg single-dose administration of methadone
      on incision (not to exceed 20 mg, as used in the literature) with a ketamine infusion of 4
      µg/kg/min and a remifentanil infusion starting at 0.1 µg/kg/min and titrating to effect or
      sufentanil infusion starting with a dose of 0.3 µg/kg/hr and titrating to effect. These
      standard doses have been well documented and studied in the literature and will be overseen
      and have been approved by Board certified anesthesiologist. For lengthier procedures, there
      will not be re-dosing of narcotics toward the end of the procedure. The operative procedure
      will not be altered in any way for the purposes of this study, and is beyond the scope of
      this protocol, yet can be detailed as requested. The patient will be taken to the recovery
      room post-operative and will be put on a standard post-operative morphine PCA at a rate of
      1mg per 6 minute lock-out period. Patient's narcotic usage and pain rating will be recorded
      at the intervals listed above and when stable from a cardiovascular standpoint, will be
      transition to the neurosurgery floor. Once able to bare weight, the patient will be
      encouraged to work with physical and occupational therapy as per standard post-operative
      protocol. Once the patient uses the PCA at a rate of less that once an hour, and can be
      managed with oral pain medications, the PCA will be removed. The remainder of their
      post-operative care will be according to the standard departmental protocol, and when
      milestones such as ambulation, voiding, and pain control are met, they will be discharged
      either to home, an acute care facility, or a subacute rehabilitation center. Any adverse
      events/reactions will be recorded and managed as normally they would be, and naloxone will be
      available for suspicion of narcotic overdose The subjects of this study will be compared to
      the historical controls in demonstrating the effect of methadone on post-operative pain,
      medication usage, and rehabilitation time. A goal of 30 patients will be planned to be
      enrolled. Other than intra-operative narcotic administration, all other portions of the
      intra-operative and post-operative care will remain the same as for historical patients.

      The primary outcomes for the study include total narcotic dose post-operative, frequency of
      narcotic use, the time to first ambulation after surgery with physical therapy, length of
      stay, and disposition (i.e. level of rehabilitative care). Secondary outcomes include better
      subjective pain control, need for post-operative course of dexamethasone for
      post-operative/post-fusion radiculopathy or neurapraxia/neuropathy, and fusion at 3-6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Health-related Quality of Life (SF-36)
time frame: Preoperatively
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 4 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 8 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 12 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 16 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 20 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 24 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 28 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 32 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 36 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 40 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 44 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 48 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 52 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 56 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 60 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 64 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 68 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 72 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 76 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 80 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 84 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 88 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 92 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Overall Health-related Quality of Life (SF-36)
time frame: 96 hours after surgery
description: The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.
measure: Time to First Ambulation
time frame: Immediately postoperatively until ambulation, on average 3-4 days
description: Unit: days. Assessments of patients' time to first ambulation post-operatively
measure: Time to Discharge From Hospital
time frame: Immediately postoperatively until patient discharge, on average 1 week, up to 1 month
description: Unit: days. Measured at patient discharge (=length of stay)
measure: Total Narcotic Dose in the Hospital
time frame: Intraoperatively until patient discharge, on average 1 week, up to 1 month
description: Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)
measure: Frequency of Narcotic Usage
time frame: Intraoperatively until patient discharge, on average 1 week, up to 1 month
description: Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)
measure: Patient Disposition at Discharge
time frame: At patient discharge, on average 1 week, up to 1 month
description: Level of rehabilitative care deemed to be required (upon patient discharge)
measure: Post-operative Course of Dexamethasone
time frame: Intraoperatively through patient discharge, on average 1 week, up to 1 month
description: Binary assessment of need for post-operative course of Dexamethasone for post-operative/post-fusion radiculopathy or neurapraxia/neuropathy
measure: Assessment of Lumbar Fusion
time frame: 3-6 months
description: Confirmation of successful fusion of lumbar vertebrae
arm group label: Intra-operative Methadone Hydrochloride
arm group type: Experimental
description: Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise
arm group label: Control
arm group type: Active Comparator
description: Patients administered standard of care
intervention type: Drug
intervention name: Methadone Hydrochloride
description: IV administration of methadone intra-operatively for a single dose
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Other
intervention name: Standard pain regimen
description: Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Procedure
intervention name: Spinal Fusion Surgery
description: Clinically-indicated spinal fusion surgery
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Drug
intervention name: Dexamethasone
description: Post operative swelling and pain control
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Drug
intervention name: Ketamine
description: Perioperative anesthesia medication
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Drug
intervention name: Remifentanil
description: Perioperative pain medication
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
intervention type: Drug
intervention name: Sufentanil
description: Perioperative pain medication
arm group label: Control
arm group label: Intra-operative Methadone Hydrochloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew J Kobets, MD, MHS
role: Principal Investigator
affiliation: Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center
last name: Merritt D Kinon, MD
role: Principal Investigator
affiliation: Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center
facility: 
country: United States
citation: Inturrisi CE. Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):435-7.
PMID: 16012416
citation: Lugo RA, Satterfield KL, Kern SE. Pharmacokinetics of methadone. J Pain Palliat Care Pharmacother. 2005;19(4):13-24.
PMID: 16431829
citation: Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14.
PMID: 22978825
citation: Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.
PMID: 22037641
citation: Pacreu S, Fernandez Candil J, Molto L, Carazo J, Fernandez Galinski S. The perioperative combination of methadone and ketamine reduces post-operative opioid usage compared with methadone alone. Acta Anaesthesiol Scand. 2012 Nov;56(10):1250-6. doi: 10.1111/j.1399-6576.2012.02743.x. Epub 2012 Jul 26.
PMID: 22834921
citation: Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.
PMID: 25837528
citation: Jacobson L, Chabal C, Brody MC, Ward RJ, Ireton RC. Intrathecal methadone and morphine for postoperative analgesia: a comparison of the efficacy, duration, and side effects. Anesthesiology. 1989 May;70(5):742-6. doi: 10.1097/00000542-198905000-00005.
PMID: 2655501
citation: Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.
PMID: 6742480
citation: Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PMID: 20418538
citation: Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.
PMID: 22063370
citation: Russell T, Mitchell C, Paech MJ, Pavy T. Efficacy and safety of intraoperative intravenous methadone during general anaesthesia for caesarean delivery: a retrospective case-control study. Int J Obstet Anesth. 2013 Jan;22(1):47-51. doi: 10.1016/j.ijoa.2012.10.007. Epub 2012 Dec 7.
PMID: 23219678
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Sufentanil
mesh term: Ketamine
mesh term: Remifentanil
mesh term: Methadone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 