RecruitingNot ApplicableNCT07265557

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


Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria20

  • 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.
  • Unable to obtain informed consent.
  • Non-English speaking
  • Eligible patient was not approached prior to hospital discharge (missed participant).
  • Did not provide informed consent (declined participation).
  • Other reason to exclude the patient, as approved by the Principal Investigator

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Interventions

OTHERDischarge 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.


Locations(1)

Mass

Boston, Massachusetts, United States

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NCT07265557


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