Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Pilot Study; Opioid; Orthopaedic Related Pain (Musculoskeletal Pain)
• Intervention / Treatment: Other: Discharge pain medication prescription

Detailed Description

This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arun Aneja, MD, PhD; Phone Number: 617-726-6546; Email: aaneja@mgh.harvard.edu
• Study Contact Backup: Name: Sheila Sprague, PhD; Email: sprags@mcmaster.ca

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Mass
      • Contact: Arun Aneja, MD, PhD; Phone Number: 617-726-6546; Email: aaneja@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 years of age or older
2. Underwent a major operative orthopaedic procedure

Exclusion Criteria:

1. Contraindication for NSAIDs.
2. Preoperative chronic opioid use (preoperative use of >14 days and average of >30 Morphine Milligram Equivalents per day).
3. Active treatment for opioid use disorder.
4. Previous or current illicit drug use.
5. Major surgery for pathologic (cancer-related) condition.
6. Hand surgery.
7. Concurrent operative treatment by another specialty team.
8. Discharged to an extended medical care facility.
9. Incarceration.
10. Women who are pregnant or planning to become pregnant in the next 6 weeks.
11. Expected injury survival of less than 6 weeks.
12. Terminal illness with expected survival of less than 6 weeks.
13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
14. Currently enrolled in a trial that does not permit co-enrollment.
15. Prior enrollment in the trial.
16. Unable to obtain informed consent.
17. Non-English speaking
18. Eligible patient was not approached prior to hospital discharge (missed participant).
19. Did not provide informed consent (declined participation).
20. Other reason to exclude the patient, as approved by the Principal Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discharge pain medication prescription without opioids; 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; 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.
Active Comparator: Usual care discharge prescription (with opioids); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Opioid usage assessed at 2 weeks and 6 weeks post-randomization	From enrollment to the end of the follow-up at 6 weeks
Pain Interference	Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization.	From enrollment to the end of the follow-up at 6 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: McMaster University
• Investigators: Principal Investigator: Arun Aneja, MD PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: October 14, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Opioid; Pilot study; Musculoskeletal Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Musculoskeletal Pain
• Other Study ID Numbers: 2025P002285

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No