<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/NCT02202369</url>
  </required_header>
  <id_info>
    <org_study_id>9080</org_study_id>
    <nct_id>NCT02202369</nct_id>
  </id_info>
  <brief_title>Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study</brief_title>
  <official_title>Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoCarolina Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charlotte Orthopedic Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OrthoCarolina Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if post-operative pain and rate of recovery are&#xD;
      improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to&#xD;
      usual analgsic care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion&#xD;
      patients treated with either MMA pain management protocol or standard pain management&#xD;
      protocol.&#xD;
&#xD;
      Controlling postoperative pain is a critical first step in facilitating a patient's recovery&#xD;
      and improved quality of life. In-hospital pain levels will be measured using a numeric pain&#xD;
      scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard&#xD;
      of care protocol. Assessments are every four to six hours, within 60 minutes after receiving&#xD;
      a pain medication&#xD;
&#xD;
      Hypothesis: Patients treated with the MMA pain protocol will have significantly less&#xD;
      immediate postoperative pain as compared to patients treated with the standard pain protocol.&#xD;
&#xD;
      Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption&#xD;
      of single level lumbar fusion patients treated with either MMA pain management protocol or&#xD;
      standard pain management protocol.&#xD;
&#xD;
      Decreasing narcotic consumption following lumbar spinal fusion surgery is important for&#xD;
      faster recovery for the patient, decreasing narcotic related side effects (nausea and&#xD;
      vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount&#xD;
      of narcotic use during the course of the hospitalization for each subject will be recorded.&#xD;
      Dosages of narcotics will be converted to morphine equivalents.&#xD;
&#xD;
      Hypothesis: Patients treated with the MMA pain protocol will consume significantly less&#xD;
      immediate postoperative narcotic pain medications compared to patients treated with the&#xD;
      standard pain protocol.&#xD;
&#xD;
      Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion&#xD;
      patients treated with either MMA pain management protocol or standard pain management&#xD;
      protocol.&#xD;
&#xD;
      Decreasing the amount of time patients remain in the hospital may decrease the time it takes&#xD;
      a patient to return to personal and societal responsibilities. Additionally it reduces the&#xD;
      patients risk of a nosocomial infection and reduces the costs of the surgery.&#xD;
&#xD;
      Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced&#xD;
      length of stay in the hospital compared to patients treated with the standard pain protocol.&#xD;
&#xD;
      Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion&#xD;
      patients treated with either MMA pain management protocol or standard pain management&#xD;
      protocol.&#xD;
&#xD;
      The primary purpose of lumbar fusion surgery is to improve the quality of life for patients.&#xD;
      The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans&#xD;
      Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient&#xD;
      reported outcome measures will be collected pre-operatively and at each of the following&#xD;
      postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.&#xD;
&#xD;
      Hypothesis: Patients treated with the MMA pain protocol will have significantly greater&#xD;
      improvement in Quality of Life measures compared to patients treated with the standard pain&#xD;
      protocol and this will be sustained out to two years post-operatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Low enrollment and subject followup rates&#xD;
  </why_stopped>
  <start_date type="Actual">June 25, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2050</completion_date>
  <primary_completion_date type="Actual">February 3, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient reported pain level using a verbal numeric pain scale (NPS)</measure>
    <time_frame>In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)</time_frame>
    <description>While in the hospital, patient's pain is assessed by a nurse-driven standard of care protocol. Assessments are typically every four to six hours or within 60 minutes after receiving an intravenous or oral analgesic medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)</time_frame>
    <description>As part of the nurse driven standard of care protocol, patients are asked if their pain level is acceptable during their stay in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic consumption</measure>
    <time_frame>In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)</time_frame>
    <description>The total amount of narcotic use during the course of hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Hospital discharge (an expected average of 2 days after surgery)</time_frame>
    <description>The number of hours of hospitalization from entering the recovery room (time zero) until the patient meets discharge criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge destination</measure>
    <time_frame>Hospital discharge (an expected average of 2 days after surgery)</time_frame>
    <description>As standard of care this data point will be documented in the patients chart. It is categorized as patient home, rehabilitation facility, or skilled nursing facility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative</time_frame>
    <description>A disease specific questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Veterans Rand 12 (VR-12)</measure>
    <time_frame>pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative</time_frame>
    <description>A general health questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Single Level Lumbar Decompression and Fusion Spine Surgery</condition>
  <arm_group>
    <arm_group_label>Multimodal Analgesia (MMA) Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Pain Managment Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimodal Analgesia Treatment</intervention_name>
    <description>Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.</description>
    <arm_group_label>Multimodal Analgesia (MMA) Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care Pain Management Protocol</intervention_name>
    <description>Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)</description>
    <arm_group_label>Standard of Care Pain Managment Protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects undergoing a single level lumbar decompression and fusion&#xD;
&#xD;
          2. &gt; 18 years of age and &lt; 70 years of age&#xD;
&#xD;
          3. The subject is willing and able to understand, sign and date the study specific&#xD;
             patient informed consent and HIPAA authorization to volunteer participation in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with liver disease (documented liver function test abnormality)&#xD;
&#xD;
          2. Patients with renal disease (documented glomerular filtration rate &lt; 60mL/min/1.73m2)&#xD;
&#xD;
          3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine&#xD;
             equivalents/day.&#xD;
&#xD;
          4. Patients with active alcohol dependence&#xD;
&#xD;
          5. Patients with active illicit drug dependence&#xD;
&#xD;
          6. Patients &lt; 18 years of age and &gt;70 years of age&#xD;
&#xD;
          7. Patients allergic to any medication given in either arm (list medications)&#xD;
&#xD;
          8. Patients who have a seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alden Milam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoCarolina Research Institute, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multimodal Analgesia</keyword>
  <keyword>Pain Management</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02202369
org study id: 9080
nct id: NCT02202369
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if post-operative pain and rate of recovery are
      improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to
      usual analgsic care.
Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion
      patients treated with either MMA pain management protocol or standard pain management
      protocol.

      Controlling postoperative pain is a critical first step in facilitating a patient's recovery
      and improved quality of life. In-hospital pain levels will be measured using a numeric pain
      scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard
      of care protocol. Assessments are every four to six hours, within 60 minutes after receiving
      a pain medication

      Hypothesis: Patients treated with the MMA pain protocol will have significantly less
      immediate postoperative pain as compared to patients treated with the standard pain protocol.

      Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption
      of single level lumbar fusion patients treated with either MMA pain management protocol or
      standard pain management protocol.

      Decreasing narcotic consumption following lumbar spinal fusion surgery is important for
      faster recovery for the patient, decreasing narcotic related side effects (nausea and
      vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount
      of narcotic use during the course of the hospitalization for each subject will be recorded.
      Dosages of narcotics will be converted to morphine equivalents.

      Hypothesis: Patients treated with the MMA pain protocol will consume significantly less
      immediate postoperative narcotic pain medications compared to patients treated with the
      standard pain protocol.

      Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion
      patients treated with either MMA pain management protocol or standard pain management
      protocol.

      Decreasing the amount of time patients remain in the hospital may decrease the time it takes
      a patient to return to personal and societal responsibilities. Additionally it reduces the
      patients risk of a nosocomial infection and reduces the costs of the surgery.

      Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced
      length of stay in the hospital compared to patients treated with the standard pain protocol.

      Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion
      patients treated with either MMA pain management protocol or standard pain management
      protocol.

      The primary purpose of lumbar fusion surgery is to improve the quality of life for patients.
      The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans
      Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient
      reported outcome measures will be collected pre-operatively and at each of the following
      postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.

      Hypothesis: Patients treated with the MMA pain protocol will have significantly greater
      improvement in Quality of Life measures compared to patients treated with the standard pain
      protocol and this will be sustained out to two years post-operatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient reported pain level using a verbal numeric pain scale (NPS)
time frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
description: While in the hospital, patient's pain is assessed by a nurse-driven standard of care protocol. Assessments are typically every four to six hours or within 60 minutes after receiving an intravenous or oral analgesic medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
measure: Patient satisfaction
time frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
description: As part of the nurse driven standard of care protocol, patients are asked if their pain level is acceptable during their stay in the hospital
measure: Narcotic consumption
time frame: In hospital (participants will be followed for the duration of the hospital stay, an expected average of 2 days)
description: The total amount of narcotic use during the course of hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
measure: Length of stay
time frame: Hospital discharge (an expected average of 2 days after surgery)
description: The number of hours of hospitalization from entering the recovery room (time zero) until the patient meets discharge criteria
measure: Discharge destination
time frame: Hospital discharge (an expected average of 2 days after surgery)
description: As standard of care this data point will be documented in the patients chart. It is categorized as patient home, rehabilitation facility, or skilled nursing facility
measure: Oswestry Disability Index (ODI)
time frame: pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative
description: A disease specific questionnaire
measure: The Veterans Rand 12 (VR-12)
time frame: pre-operative, 2 week post-operative, 6 week post-operative, 3 month post-operative, 6 month post-operative, 1 year post-operative, 2 year post-operative
description: A general health questionnaire
arm group label: Multimodal Analgesia (MMA) Treatment
arm group type: Experimental
arm group label: Standard of Care Pain Managment Protocol
arm group type: Active Comparator
intervention type: Other
intervention name: Multimodal Analgesia Treatment
description: Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.
arm group label: Multimodal Analgesia (MMA) Treatment
intervention type: Other
intervention name: Standard of Care Pain Management Protocol
description: Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)
arm group label: Standard of Care Pain Managment Protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alden Milam, MD
role: Principal Investigator
affiliation: OrthoCarolina Research Institute, Inc.
facility: 
country: United States
responsible party type: Sponsor