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Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02987920
Recruitment Status : Terminated (The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol.)
First Posted : December 9, 2016
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hanna Schittek, University of Southern California

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Dextromethorphan Drug: Placebo - Concentrate Drug: Acetaminophen Drug: Oxycodone Drug: Celecoxib Drug: Pantoprazole Drug: Ketorolac Drug: Gabapentin Drug: Hydromorphone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Placebo - Concentrate

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

Drug: Placebo - Concentrate
Additional medication to perioperative analgesic regimen to Group A
Other Name: placebo, placebos, sugar water

Drug: Acetaminophen
Multimodal analgesic regimen to Group A and Group B
Other Name: tylenol

Drug: Oxycodone
Multimodal analgesic regimen to Group A and Group B
Other Names:
  • oxycodone extended release
  • oxycontin

Drug: Celecoxib
Multimodal analgesic regimen to Group A and Group B
Other Name: celebrex

Drug: Pantoprazole
Multimodal analgesic regimen to Group A and Group B
Other Name: protonix

Drug: Ketorolac
Multimodal analgesic regimen to Group A and Group B
Other Name: toradol

Drug: Gabapentin
Multimodal analgesic regimen to Group A and Group B
Other Name: neurontin

Drug: Hydromorphone
Multimodal analgesic regimen to Group A and Group B
Other Name: dilaudid

Experimental: Dextromethorphan

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

Drug: Dextromethorphan
Additional medication to perioperative analgesic regimen in Group B
Other Name: delsym

Drug: Acetaminophen
Multimodal analgesic regimen to Group A and Group B
Other Name: tylenol

Drug: Oxycodone
Multimodal analgesic regimen to Group A and Group B
Other Names:
  • oxycodone extended release
  • oxycontin

Drug: Celecoxib
Multimodal analgesic regimen to Group A and Group B
Other Name: celebrex

Drug: Pantoprazole
Multimodal analgesic regimen to Group A and Group B
Other Name: protonix

Drug: Ketorolac
Multimodal analgesic regimen to Group A and Group B
Other Name: toradol

Drug: Gabapentin
Multimodal analgesic regimen to Group A and Group B
Other Name: neurontin

Drug: Hydromorphone
Multimodal analgesic regimen to Group A and Group B
Other Name: dilaudid




Primary Outcome Measures :
  1. Total amount of postoperative opioid used in first 48 hours after knee replacement. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. VAS pain scores [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Total postoperative opioid requirements [ Time Frame: Through study completion, an average of 1 year ]
  2. Presence of postoperative nausea and vomiting [ Time Frame: 24 hours ]
    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

  3. Duration of adductor canal catheter [ Time Frame: 72 hours ]
  4. Length of hospital stay [ Time Frame: 72 hours ]
  5. Patient satisfaction questionnaire [ Time Frame: 4 weeks ]
    Patients will be called after discharged from hospital to go through a questionnaire to assess their satisfaction with pain control



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>18 years of age, American Society of Anesthesiologists (ASA) > IIII) who are undergoing only elective primary total knee replacement will be included in the study.

Exclusion Criteria:

  • patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, chronic pain diagnoses, the presence of coagulopathy or infection, or pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987920


Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Hanna Schittek, MD University of Southern California

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Responsible Party: Hanna Schittek, Clinical Assistance Professor of Anesthesiology, University of Southern California
ClinicalTrials.gov Identifier: NCT02987920     History of Changes
Other Study ID Numbers: HS-16-00739
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Celecoxib
Ketorolac
Ketorolac Tromethamine
Oxycodone
Gabapentin
Hydromorphone
Pantoprazole
Dextromethorphan
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics