PO Methadone Ortho Outpatient

March 3, 2025 updated by: Abigail Song, Keck School of Medicine of USC

Use of Single-Dose Oral Methadone for Pain Management in Outpatient Arthroscopic Hip and Knee Procedures

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY METHOD We plan to perform a double-blinded randomized control study, where the participants, anesthesiologist, data collectors, and study team will be unaware of the intervention offered. Participants will be randomly assigned to the control group (standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion) or to the intervention group (a single dose of perioperative oral methadone).

Patients will be recruited and consented to whether they want to participate in the study by a member of the team during a pre-operative clinic visit (Anesthesia START clinic or orthopedic surgery clinic) or on day-of-surgery in the pre-op holding area.

Participants will be randomized to either the control group or treatment group using randomization software. Participants assigned to the intervention group will receive a single dose of oral methadone will be administered in the pre-operative holding area. Dosing will be weight dependent, using 0.15mg/kg ideal body weight (IBW) as a reference; participants weighing less than 50kg will receive 5mg oral methadone, while participants weighing more than 50kg will receive 10mg oral methadone. Participants assigned to the control group will receive an identical-looking placebo sugar pill. A study pharmacist will deliver the appropriate pill to the patient or pre-op nurse in the pre-op holding area on the day of surgery.

Pre-operatively, all participants will complete a survey collecting data on visual analog scale (VAS) pain scores for the 2 weeks leading up to surgery, whether this is different from their baseline pain score at home (if applicable), and pre-operative opioid usage (if applicable). All participants will receive standard-of-care pre-operative non-opioid medications as determined by the orthopedic surgical team if needed.

Intraoperatively, participants will receive either GA or monitored anesthesia care, at the discretion of the anesthesia care team.

In the post-anesthesia acute care unit (PACU), all participants will receive standard PACU medications (ie. intravenous dilaudid or oral oxycodone, and acetaminophen as needed) for pain relief. Pain scores on a 1-10 scale and amount of opioid usage will be collected per standard PACU protocol upon arrival, after 30 minutes, and after 60 minutes. Post-discharge, all participants will receive oxycodone-acetaminophen for at-home pain (as standardized by the orthopedic surgery team) to be used as needed for breakthrough pain refractory to acetaminophen/ibuprofen, or in patients where these medications are contraindicated.

Following discharge, a member of the study team will call participants on post-operative day 1 and post-operative day 2 to assess pain scores and opioid usage. Participants will also be discharged with a pain diary to assist in documenting endpoints. They will also be asked to document any complications or adverse events at each of these time intervals.

Once the data collection is complete, we will perform statistics (detailed below) to determine if there is any significant difference. The primary outcome will be post-discharge opioid usage, and the secondary outcome will be patient-perceived pain scores at the time intervals above.

STRATIFICATION/DESCRIPTIVE FACTORS/RANDOMIZATION SCHEME

Participants will not be stratified prior to randomization.

Descriptive factors: age, gender, BMI will be looked to assess for possible confounding variables, but will not affect group assignment.

The website randomizer.org will assist in our randomization of participants enrolled in the study. The software randomly determines which participant will be assigned to Control vs Treatment group in a 1:1 ratio. At the onset of the study, we will create a predetermined randomization list (containing study participant code and treatment arm assignment), and provide it to the study pharmacist who will then be the only one with access to this linked info. The study pharmacist will be informed of the new enrollment and will read back the study code to the team member, who will record it in a separate data collection form that contains link between Medical Record Number and participant code. The pharmacist will strike out the participant code on their sheet to keep track of used codes, then prepare the appropriate medication and deliver it to the participant or pre-op nurse in the pre-op holding area on the day of surgery.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander Chen, M.D.
  • Phone Number: 323-442-7400
  • Email: painmed@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Healthcare Consultation 3
        • Contact:
        • Contact:
          • Abigail Song, B.S.
        • Contact:
          • Benjamin Liu, M.D.
        • Contact:
          • Paul Lee, M.D., M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
placebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion
Drug: Placebo
sugar pill that is identical look-alike to study drug
Experimental: Interventional
5mg PO methadone for participants <50kg or 10mg PO methadone for participants >50kg
Drug: Methadone group
5mg PO methadone for participants <50kg or 10mg PO methadone for participants >50kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-op opioid usage
Time Frame: at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-op Pain Score
Time Frame: at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
pain scores on the visual analog scale (VAS)
at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keck School of Medicine of USC

Investigators

  • Principal Investigator: Alexander Chen, M.D., Keck School of Medicine of USC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-24-00554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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