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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mass
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Arun Aneja, MD PhD — Massachusetts General Hospital
• Study coordinator: Arun Aneja, MD, PhD
• Email: aaneja@mgh.harvard.edu
• Phone: 617-726-6546

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dexmedetomidine as add-on for refractory cancer pain in palliative care

  This study tests whether adding dexmedetomidine helps improve pain control for adults with cancer in palliative care whose pain remains high despite opioids.

  Recruiting St. Olavs Hospital · Drammen and 3 other locations · NCT07885475

• How MOR Activation Affects Stress and Social Behavior, and How Childhood Unpredictability Modulates This in Men and Women

  This study tests whether activating the mu opioid receptor with morphine changes stress responses and social behavior, and whether sex and early life unpredictability alter those effects.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07778511

• Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study

  This study tests whether daily patterns like sleep, activity, and meal timing in early pregnancy affect glucose levels and the risk of gestational diabetes, using CGM and wearable data in pregnant women in Singapore.

  Recruiting KK Women's and Children's Hospital · Singapore, Singapore · NCT07534670

• Mindfulness for fracture recovery and reduced opioid use before and after surgery

  This trial tests whether a brief, guided mindfulness exercise before and after fracture surgery can reduce anxiety and pain and help cut opioid use for adults with fractures.

  Recruiting McMaster University · Hamilton, Ontario · NCT07486505

• 4‑FN PET/CT scans to detect and track chronic graft‑versus‑host disease in joints

  This pilot will test whether a PET/CT scan using the tracer 4‑[18F]Fluoro‑1‑naphthol (4FN) is safe and can detect or predict chronic graft‑versus‑host disease manifestations in adults.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07325253

• Erector spinae block to lower opioid use after total abdominal hysterectomy

  This will test whether giving an erector spinae nerve block during general anesthesia can reduce opioid use for people having an elective total abdominal hysterectomy.

  Recruiting Phase 4 Kulsoom International Hospital · Islamabad, Federal · NCT07178262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.