Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

NCT07265557 | Recruiting DMC

• 1 other identifier: 2025P002285
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.

Conditions

Orthopaedic Related Pain (Musculoskeletal Pain); Pilot Study; Opioid; Pain

Keywords

Opioid; Pilot study; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Feasibility of patient enrollment and treatment allocation

  Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Participant enrollment * Feasibility of treatment allocation * Data collection methods (Proportion of participants with missing data) * Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)

  From enrollment to the end of the follow-up phase at 6 weeks

Secondary Outcomes (2)

• Opioid Use

  From enrollment to the end of the follow-up at 6 weeks

• Pain Interference

  From enrollment to the end of the follow-up at 6 weeks

Study Arms (2)

Discharge pain medication prescription without opioids

EXPERIMENTAL

The treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician.

Other: Discharge pain medication prescription

Usual care discharge prescription (with opioids)

ACTIVE COMPARATOR

The control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician.

Other: Discharge pain medication prescription

Interventions

Discharge pain medication prescription OTHER

The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.

Discharge pain medication prescription without opioids; Usual care discharge prescription (with opioids)

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Underwent a major operative orthopaedic procedure

You may not qualify if:

• Contraindication for NSAIDs.
• Preoperative chronic opioid use (preoperative use of \>14 days and average of \>30 Morphine Milligram Equivalents per day).
• Active treatment for opioid use disorder.
• Previous or current illicit drug use.
• Major surgery for pathologic (cancer-related) condition.
• Hand surgery.
• Concurrent operative treatment by another specialty team.
• Discharged to an extended medical care facility.
• Incarceration.
• Women who are pregnant or planning to become pregnant in the next 6 weeks.
• Expected injury survival of less than 6 weeks.
• Terminal illness with expected survival of less than 6 weeks.
• Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
• Currently enrolled in a trial that does not permit co-enrollment.
• Prior enrollment in the trial.

Sponsors & Collaborators

• McMaster University: collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Mass

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun Aneja, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arun Aneja, MD, PhD

CONTACT

617-726-6546; aaneja@mgh.harvard.edu

Sheila Sprague, PhD

CONTACT

sprags@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: December 5, 2025
• Study Start: October 6, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)