<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/NCT02987920</url>
  </required_header>
  <id_info>
    <org_study_id>HS-16-00739</org_study_id>
    <nct_id>NCT02987920</nct_id>
  </id_info>
  <brief_title>Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty</brief_title>
  <official_title>A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total knee arthroplasty (TKA) is one of the most painful orthopedic procedures. After TKA&#xD;
      surgery, postoperative pain relief may be achieved using a variety of techniques. Integral to&#xD;
      recovery and improved outcomes is early ambulation and mobilization. Achieving adequate&#xD;
      postoperative pain control while ensuring the ability to ambulate early can be quite&#xD;
      challenging.&#xD;
&#xD;
      Currently, in our country there has been a call to address prescription opioid use and abuse&#xD;
      due to a nationwide opioid epidemic. In light of this, improving our multimodal analgesic&#xD;
      protocol will serve to decrease reliance of opioid medications for pain control. Multimodal&#xD;
      analgesia is effective in decreasing total opioid consumption postoperatively.&#xD;
      Dextromethorphan is a low-affinity noncompetitive N-methyl-D-aspartate (NMDA) receptor&#xD;
      antagonist. It has a long history of clinical use with an established safety record. Studies&#xD;
      have shown that it has a positive effect as an analgesic.&#xD;
&#xD;
      In order to see if dextromethorphan will decrease opioid use, this study will look at two&#xD;
      patient groups undergoing total knee arthroplasty with the same preoperative, intraoperative,&#xD;
      and postoperative anesthetic plan with the exception of the addition of dextromethorphan to&#xD;
      one groups multimodal analgesic regimen. This study is designed as a double-blinded,&#xD;
      randomized, prospective cohort trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will receive as part of their standard of care a spinal with sedation for&#xD;
      intraoperative anesthesia.&#xD;
&#xD;
      Subjects will be randomly assigned using computer generated allotment. The group designation&#xD;
      will be placed in sealed envelopes. The group listed will determine whether or not they will&#xD;
      receive dextromethorphan as part of their preoperative preincisional analgesic regimen. Only&#xD;
      the pharmacist dispensing the medication will be unblinded. The drug and placebo will then be&#xD;
      concealed by the pharmacist and delivered to the patient to ingest in the preoperative area.&#xD;
&#xD;
      Group A: standard preop meds&#xD;
&#xD;
      Group B: standard preop meds + dextromethorphan&#xD;
&#xD;
      The standard preoperative analgesic regimen will include placement of an adductor canal&#xD;
      catheter nerve block, acetaminophen 1000mg PO, oxycodone extended release 10mg PO, celecoxib&#xD;
      400mg PO (held if elevated creatinine), and pantoprazole 40mg PO&#xD;
&#xD;
      All blocks will be performed by resident trainees under the supervision of anesthesia&#xD;
      regional and acute pain attendings. The continuous adductor canal nerve block will be placed&#xD;
      using B-Braun &quot;Contiplex Continuous Peripheral Nerve Block Tray&quot;, using 20g catheters.&#xD;
&#xD;
      Intraoperative anesthesia will be performed with spinal injection using local anesthestic&#xD;
      only. No opioid will be given intrathecally. Intraoperative sedation will include standard&#xD;
      sedation with propofol infusion. Postoperative nausea and vomiting prophylaxis will include&#xD;
      ondansetron, propofol infusion, and dexamethasone 0.1mg/kg if not contraindicated. The&#xD;
      postoperative recovery room pain protocol will include the following: starting the adductor&#xD;
      canal catheter infusion with &quot;On-Q&quot; pump dispensing ropivicaine 0.1% at 4ml/hr, oxycodone 5&#xD;
      10mg po for moderate to severe pain, dilaudid 0.2mg IV q5min up to 2 mg, ketorolac 30mg&#xD;
      intravenous (IV) once, and acetaminophen 1000mg intravenous once if greater than 6 hours has&#xD;
      elapsed since initial preoperative dose.&#xD;
&#xD;
      Assessments of pain using the VAS pain score will be performed in postanesthesia care unit&#xD;
      (PACU) at the time of spinal block cessation by a blinded observer (recovery room nurse), and&#xD;
      then subsequently every 4 hours by a registered nurse and documented in the electronic&#xD;
      medical record. Initial evaluation for resolution of the spinal blockade will be performed at&#xD;
      the 1 hour timepoint in the PACU.&#xD;
&#xD;
      Assessments of opioid administration, will include all medications given and documented in&#xD;
      the electronic medical record. The various time points analyzed will include intraoperative,&#xD;
      PACU, and daily postoperative morphine equivalents administered to each patient.&#xD;
&#xD;
      Postoperative followup will be done by research personnel blinded to the group distribution.&#xD;
      Visual Analog Scale for Pain (VAS Pain) will be performed every 4 hours until discharge.&#xD;
&#xD;
      On postoperative day (POD) #1, all patients will be given the Quality of Recovery (QoR)&#xD;
      Questionnaire. This is recovery specific, patient rated questionnaire containing 40 items&#xD;
      measuring 5 dimensions. The QoR 40 was specifically designed to measure a patient's health&#xD;
      status after surgery and anesthesia, and its completion time generally ranges from 3 to 10&#xD;
      min. The five dimensions measured include: the physical comfort (12 items), emotional state&#xD;
      (nine items), physical independence (five items), psychological support (seven items) and&#xD;
      pain (seven items). The total score and subscales of the QoR 40 are measured using a five&#xD;
      point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for&#xD;
      negative items, the scoring was reversed) and individual scores are then added together, with&#xD;
      the minimum score being 40 points and the maximum score being 200 points.&#xD;
&#xD;
      In addition, the study will require home follow up phone calls assessing the occurrence of&#xD;
      any possible side effects or complications, pain, and postoperative opioid use. These phone&#xD;
      calls will occur at POD#3 after discharge, POD #7, POD #14, and POD#28. Each of these phone&#xD;
      assessments will require about 5 minutes of time. Authorized research personnel of the study&#xD;
      project will be making the phone calls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The surgeon changed pain control protocol for all patients. Continued enrollment impossible&#xD;
    under approved protocol.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Total amount of postoperative opioid used in first 48 hours after knee replacement.</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS pain scores</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Total postoperative opioid requirements</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Presence of postoperative nausea and vomiting</measure>
    <time_frame>24 hours</time_frame>
    <description>Will ask patient if they felt nauseated or had any episodes of emesis within the first 24 hours postoperatively. Will obtain yes or no answer to nausea and emesis specifically</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of adductor canal catheter</measure>
    <time_frame>72 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>72 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction questionnaire</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patients will be called after discharged from hospital to go through a questionnaire to assess their satisfaction with pain control</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preoperative oral medications given one time: acetaminophen 1000mg tablet, oxycodone extended release 10mg tablet, celecoxib 400mg tablet, pantoprazole 40mg tablet, and Placebo - Concentrate by mouth.&#xD;
postoperative medications given for 2 days: Acetaminophen 1000mg every 6hr, Ketorolac15mg IV q6hrs x4 doses, Oxycodone 5mg po q3hrs prn moderate pain, Oxycodone10mg po q3hrs prn severe pain, Gabapentin100-300mg once at night, Dilaudid 0.2mg IV q2hrs prn severe pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>preoperative oral medications given one time: acetaminophen 1000mg tablet, oxycodone extended release 10mg tablet, celecoxib 400mg tablet, pantoprazole 40mg tablet, and Dextromethorphan 60mg tablet&#xD;
postoperative medications given for 2 days: Acetaminophen 1000mg every 6hr, Ketorolac15mg IV q6hrs x4 doses, Oxycodone 5mg po q3hrs prn moderate pain, Oxycodone10mg po q3hrs prn severe pain, Gabapentin100-300mg once at night, Dilaudid 0.2mg IV q2hrs prn severe pain, and dextromethorphan 60mg by mouth twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextromethorphan</intervention_name>
    <description>Additional medication to perioperative analgesic regimen in Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <other_name>delsym</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Concentrate</intervention_name>
    <description>Additional medication to perioperative analgesic regimen to Group A</description>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>placebo, placebos, sugar water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>oxycodone extended release</other_name>
    <other_name>oxycontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>celebrex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>protonix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>toradol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>neurontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>Multimodal analgesic regimen to Group A and Group B</description>
    <arm_group_label>Dextromethorphan</arm_group_label>
    <arm_group_label>Placebo - Concentrate</arm_group_label>
    <other_name>dilaudid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years of age, American Society of Anesthesiologists (ASA) &gt; IIII)&#xD;
             who are undergoing only elective primary total knee replacement will be included in&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal to be included in the study, contraindications to regional anesthesia,&#xD;
             history of allergy to amide local anesthetics, the presence of a progressive&#xD;
             neurological deficit, chronic pain diagnoses, the presence of coagulopathy or&#xD;
             infection, or pregnancy.&#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>Hanna Schittek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>May 11, 2019</last_update_submitted>
  <last_update_submitted_qc>May 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Hanna Schittek</investigator_full_name>
    <investigator_title>Clinical Assistance Professor of Anesthesiology</investigator_title>
  </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>Acetaminophen</mesh_term>
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
    <mesh_term>Dextromethorphan</mesh_term>
    <mesh_term>Pantoprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 11, 2019</submitted>
    <returned>July 2, 2019</returned>
    <submitted>October 6, 2019</submitted>
    <submission_canceled>October 9, 2019</submission_canceled>
    <submitted>November 2, 2020</submitted>
    <returned>November 24, 2020</returned>
    <submitted>November 24, 2020</submitted>
    <returned>December 18, 2020</returned>
  </pending_results>
  <!-- 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/NCT02987920
org study id: HS-16-00739
nct id: NCT02987920
lead sponsor: 
has dmc: Yes
Total knee arthroplasty (TKA) is one of the most painful orthopedic procedures. After TKA
      surgery, postoperative pain relief may be achieved using a variety of techniques. Integral to
      recovery and improved outcomes is early ambulation and mobilization. Achieving adequate
      postoperative pain control while ensuring the ability to ambulate early can be quite
      challenging.

      Currently, in our country there has been a call to address prescription opioid use and abuse
      due to a nationwide opioid epidemic. In light of this, improving our multimodal analgesic
      protocol will serve to decrease reliance of opioid medications for pain control. Multimodal
      analgesia is effective in decreasing total opioid consumption postoperatively.
      Dextromethorphan is a low-affinity noncompetitive N-methyl-D-aspartate (NMDA) receptor
      antagonist. It has a long history of clinical use with an established safety record. Studies
      have shown that it has a positive effect as an analgesic.

      In order to see if dextromethorphan will decrease opioid use, this study will look at two
      patient groups undergoing total knee arthroplasty with the same preoperative, intraoperative,
      and postoperative anesthetic plan with the exception of the addition of dextromethorphan to
      one groups multimodal analgesic regimen. This study is designed as a double-blinded,
      randomized, prospective cohort trial.
Each subject will receive as part of their standard of care a spinal with sedation for
      intraoperative anesthesia.

      Subjects will be randomly assigned using computer generated allotment. The group designation
      will be placed in sealed envelopes. The group listed will determine whether or not they will
      receive dextromethorphan as part of their preoperative preincisional analgesic regimen. Only
      the pharmacist dispensing the medication will be unblinded. The drug and placebo will then be
      concealed by the pharmacist and delivered to the patient to ingest in the preoperative area.

      Group A: standard preop meds

      Group B: standard preop meds + dextromethorphan

      The standard preoperative analgesic regimen will include placement of an adductor canal
      catheter nerve block, acetaminophen 1000mg PO, oxycodone extended release 10mg PO, celecoxib
      400mg PO (held if elevated creatinine), and pantoprazole 40mg PO

      All blocks will be performed by resident trainees under the supervision of anesthesia
      regional and acute pain attendings. The continuous adductor canal nerve block will be placed
      using B-Braun "Contiplex Continuous Peripheral Nerve Block Tray", using 20g catheters.

      Intraoperative anesthesia will be performed with spinal injection using local anesthestic
      only. No opioid will be given intrathecally. Intraoperative sedation will include standard
      sedation with propofol infusion. Postoperative nausea and vomiting prophylaxis will include
      ondansetron, propofol infusion, and dexamethasone 0.1mg/kg if not contraindicated. The
      postoperative recovery room pain protocol will include the following: starting the adductor
      canal catheter infusion with "On-Q" pump dispensing ropivicaine 0.1% at 4ml/hr, oxycodone 5
      10mg po for moderate to severe pain, dilaudid 0.2mg IV q5min up to 2 mg, ketorolac 30mg
      intravenous (IV) once, and acetaminophen 1000mg intravenous once if greater than 6 hours has
      elapsed since initial preoperative dose.

      Assessments of pain using the VAS pain score will be performed in postanesthesia care unit
      (PACU) at the time of spinal block cessation by a blinded observer (recovery room nurse), and
      then subsequently every 4 hours by a registered nurse and documented in the electronic
      medical record. Initial evaluation for resolution of the spinal blockade will be performed at
      the 1 hour timepoint in the PACU.

      Assessments of opioid administration, will include all medications given and documented in
      the electronic medical record. The various time points analyzed will include intraoperative,
      PACU, and daily postoperative morphine equivalents administered to each patient.

      Postoperative followup will be done by research personnel blinded to the group distribution.
      Visual Analog Scale for Pain (VAS Pain) will be performed every 4 hours until discharge.

      On postoperative day (POD) #1, all patients will be given the Quality of Recovery (QoR)
      Questionnaire. This is recovery specific, patient rated questionnaire containing 40 items
      measuring 5 dimensions. The QoR 40 was specifically designed to measure a patient's health
      status after surgery and anesthesia, and its completion time generally ranges from 3 to 10
      min. The five dimensions measured include: the physical comfort (12 items), emotional state
      (nine items), physical independence (five items), psychological support (seven items) and
      pain (seven items). The total score and subscales of the QoR 40 are measured using a five
      point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for
      negative items, the scoring was reversed) and individual scores are then added together, with
      the minimum score being 40 points and the maximum score being 200 points.

      In addition, the study will require home follow up phone calls assessing the occurrence of
      any possible side effects or complications, pain, and postoperative opioid use. These phone
      calls will occur at POD#3 after discharge, POD #7, POD #14, and POD#28. Each of these phone
      assessments will require about 5 minutes of time. Authorized research personnel of the study
      project will be making the phone calls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Total amount of postoperative opioid used in first 48 hours after knee replacement.
time frame: 48 hours
measure: VAS pain scores
time frame: 28 days
measure: Total postoperative opioid requirements
time frame: Through study completion, an average of 1 year
measure: Presence of postoperative nausea and vomiting
time frame: 24 hours
description: Will ask patient if they felt nauseated or had any episodes of emesis within the first 24 hours postoperatively. Will obtain yes or no answer to nausea and emesis specifically
measure: Duration of adductor canal catheter
time frame: 72 hours
measure: Length of hospital stay
time frame: 72 hours
measure: Patient satisfaction questionnaire
time frame: 4 weeks
description: Patients will be called after discharged from hospital to go through a questionnaire to assess their satisfaction with pain control
arm group label: Placebo - Concentrate
arm group type: Active Comparator
description: preoperative oral medications given one time: acetaminophen 1000mg tablet, oxycodone extended release 10mg tablet, celecoxib 400mg tablet, pantoprazole 40mg tablet, and Placebo - Concentrate by mouth.
postoperative medications given for 2 days: Acetaminophen 1000mg every 6hr, Ketorolac15mg IV q6hrs x4 doses, Oxycodone 5mg po q3hrs prn moderate pain, Oxycodone10mg po q3hrs prn severe pain, Gabapentin100-300mg once at night, Dilaudid 0.2mg IV q2hrs prn severe pain
arm group label: Dextromethorphan
arm group type: Experimental
description: preoperative oral medications given one time: acetaminophen 1000mg tablet, oxycodone extended release 10mg tablet, celecoxib 400mg tablet, pantoprazole 40mg tablet, and Dextromethorphan 60mg tablet
postoperative medications given for 2 days: Acetaminophen 1000mg every 6hr, Ketorolac15mg IV q6hrs x4 doses, Oxycodone 5mg po q3hrs prn moderate pain, Oxycodone10mg po q3hrs prn severe pain, Gabapentin100-300mg once at night, Dilaudid 0.2mg IV q2hrs prn severe pain, and dextromethorphan 60mg by mouth twice daily
intervention type: Drug
intervention name: Dextromethorphan
description: Additional medication to perioperative analgesic regimen in Group B
arm group label: Dextromethorphan
other name: delsym
intervention type: Drug
intervention name: Placebo - Concentrate
description: Additional medication to perioperative analgesic regimen to Group A
arm group label: Placebo - Concentrate
other name: placebo, placebos, sugar water
intervention type: Drug
intervention name: Acetaminophen
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: tylenol
intervention type: Drug
intervention name: Oxycodone
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: oxycodone extended release
other name: oxycontin
intervention type: Drug
intervention name: Celecoxib
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: celebrex
intervention type: Drug
intervention name: Pantoprazole
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: protonix
intervention type: Drug
intervention name: Ketorolac
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: toradol
intervention type: Drug
intervention name: Gabapentin
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: neurontin
intervention type: Drug
intervention name: Hydromorphone
description: Multimodal analgesic regimen to Group A and Group B
arm group label: Dextromethorphan
arm group label: Placebo - Concentrate
other name: dilaudid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanna Schittek, MD
role: Principal Investigator
affiliation: University of Southern California
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Hanna Schittek
investigator title: Clinical Assistance Professor of Anesthesiology
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Celecoxib
mesh term: Ketorolac
mesh term: Oxycodone
mesh term: Gabapentin
mesh term: Hydromorphone
mesh term: Dextromethorphan
mesh term: Pantoprazole
sharing ipd: No
submitted: June 11, 2019
returned: July 2, 2019
submitted: October 6, 2019
submission canceled: October 9, 2019
submitted: November 2, 2020
returned: November 24, 2020
submitted: November 24, 2020
returned: December 18, 2020