Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty

NCT02987920 | Terminated Phase 4 DMC

• 1 other identifier: HS-16-00739
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total amount of postoperative opioid used in first 48 hours after knee replacement.

  48 hours

Secondary Outcomes (1)

• VAS pain scores

  28 days

Other Outcomes (5)

• Total postoperative opioid requirements

  Through study completion, an average of 1 year

• Presence of postoperative nausea and vomiting

  24 hours

• Duration of adductor canal catheter

  72 hours

Study Arms (2)

Placebo - Concentrate

ACTIVE COMPARATOR

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; Drug: Acetaminophen; Drug: Oxycodone; Drug: Celecoxib; Drug: Pantoprazole; Drug: Ketorolac; Drug: Gabapentin; Drug: Hydromorphone

Dextromethorphan

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Oxycodone; Drug: Celecoxib; Drug: Pantoprazole; Drug: Ketorolac; Drug: Gabapentin; Drug: Hydromorphone

Interventions

Dextromethorphan DRUG

Additional medication to perioperative analgesic regimen in Group B

Also known as: delsym

Dextromethorphan

Placebo - Concentrate DRUG

Additional medication to perioperative analgesic regimen to Group A

Also known as: placebo, placebos, sugar water

Placebo - Concentrate

Acetaminophen DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: tylenol

Dextromethorphan; Placebo - Concentrate

Oxycodone DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: oxycodone extended release, oxycontin

Dextromethorphan; Placebo - Concentrate

Celecoxib DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: celebrex

Dextromethorphan; Placebo - Concentrate

Pantoprazole DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: protonix

Dextromethorphan; Placebo - Concentrate

Ketorolac DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: toradol

Dextromethorphan; Placebo - Concentrate

Gabapentin DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: neurontin

Dextromethorphan; Placebo - Concentrate

Hydromorphone DRUG

Multimodal analgesic regimen to Group A and Group B

Also known as: dilaudid

Dextromethorphan; Placebo - Concentrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dextromethorphan; Acetaminophen; Oxycodone; Celecoxib; Pantoprazole; Ketorolac; Ketorolac Tromethamine; Gabapentin; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Indomethacin; Indoles; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hanna Schittek, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistance Professor of Anesthesiology

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 9, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share