Opioid-free versus usual discharge pain plans after major orthopedic surgery.

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

This pilot trial will test whether sending adults home after major orthopedic surgery with an opioid-free pain prescription provides pain control similar to the usual opioid-containing prescription.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07265557 on ClinicalTrials.gov

What this trial studies

This single-center pilot randomized controlled trial at Massachusetts General Hospital will enroll at least 100 adults undergoing major orthopedic surgery across five subspecialties (trauma, arthroplasty, foot and ankle, spine, and sports). Participants will be randomized at discharge to receive either an opioid-free pain medication prescription or usual care including opioids. The pilot will use traffic-light feasibility criteria focused on enrollment, adherence to treatment allocation, and completeness of follow-up data to inform a larger definitive RCT. Secondary analyses will compare opioid consumption and pain interference between groups to provide preliminary effectiveness data.

Who should consider this trial

Good fit: Adults (18+) who undergo major operative orthopedic procedures and can take NSAIDs, and who are not chronic opioid users, are ideal candidates.

Not a fit: Patients on long-term opioids, those with NSAID contraindications, patients discharged to extended care, or those with active opioid use disorder are unlikely to benefit from an opioid-free discharge prescription.

Why it matters

Potential benefit: If successful, the approach could let patients recover with effective pain control while reducing opioid exposure and the risks of dependence and side effects.

How similar studies have performed: Prior enhanced recovery and nonrandomized studies suggest opioid-sparing discharge strategies can lower opioid use without worsening pain, but randomized evidence in major orthopedic populations remains limited.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

• Mass — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Arun Aneja, MD PhD — Massachusetts General Hospital
• Study coordinator: Arun Aneja, MD, PhD

Conditions Orthopaedic Related Pain; Opioid; Pain; Pilot Study; Pilot study; Musculoskeletal Pain