PO Methadone Ortho Outpatient

NCT06351215 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: APP-24-00554
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are: Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment? Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above. Participants will: Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery

Conditions

Arthroscopic Knee Repair; Arthroscopic Hip Repair

Keywords

arthroscopic knee repair; arthroscopic hip repair; oral methadone; post-operative pain control; ambulatory surgery

Outcome Measures

Primary Outcomes (1)

• Post-op opioid usage

  opioid usage, as measured in morphine equivalent doses (MED)

  at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2

Secondary Outcomes (1)

• Post-op Pain Score

  at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2

Study Arms (2)

Control

PLACEBO COMPARATOR

placebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion

Drug: Placebo

Interventional

EXPERIMENTAL

5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg

Drug: Methadone group

Interventions

Methadone group DRUG

5mg PO methadone for participants \&lt;50kg or 10mg PO methadone for participants \&gt;50kg

Interventional

Placebo DRUG

sugar pill that is identical look-alike to study drug

Control

Eligibility Criteria

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

You may qualify if:

• medically optimized participants who will undergo elective arthroscopic knee or hip repair

You may not qualify if:

• pregnant or breastfeeding, age under 18, history of respiratory compromise, allergy to opioids, recipient of pre-operative nerve block

Sponsors & Collaborators

• Keck School of Medicine of USC: lead

Study Sites (1)

USC Healthcare Consultation 3

Los Angeles, California, 90033, United States

Location

Related Publications (8)

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.

  PMID: 28418966 BACKGROUND

• 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 BACKGROUND

• Murphy GS, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Dickerson D, Bilimoria S, Benson J, Maher CE, Trenk GJ, Teister KJ, Szokol JW. Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery. Anesthesiology. 2020 Feb;132(2):330-342. doi: 10.1097/ALN.0000000000003025.

  PMID: 31939849 BACKGROUND

• Murphy GS, Avram MJ, Greenberg SB, Benson J, Bilimoria S, Maher CE, Teister K, Szokol JW. Perioperative Methadone and Ketamine for Postoperative Pain Control in Spinal Surgical Patients: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2021 May 1;134(5):697-708. doi: 10.1097/ALN.0000000000003743.

  PMID: 33730151 BACKGROUND

• Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.

  PMID: 29847382 BACKGROUND

• Kharasch ED, Brunt LM, Blood J, Komen H. Intraoperative Methadone in Next-day Discharge Outpatient Surgery: A Randomized, Double-blinded, Dose-finding Pilot Study. Anesthesiology. 2023 Oct 1;139(4):405-419. doi: 10.1097/ALN.0000000000004663.

  PMID: 37350677 BACKGROUND

• 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 BACKGROUND

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  BACKGROUND

Study Officials

• Alexander Chen, M.D.

  Keck School of Medicine of USC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Chen, M.D.

CONTACT

323-442-7400; painmed@usc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 15, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)