Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07265557

Conditions

Orthopaedic Related Pain (Musculoskeletal Pain)

Opioid

Pain

Pilot Study

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Discharge pain medication prescription

Study Details

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)

Opioid

Pain

Pilot Study

Study ID

NCT07265557

Start date

Oct 6, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Feasibility of patient enrollment and treatment allocation [ Time Frame: From enrollment to the end of the follow-up phase at 6 weeks ]

Central Contacts and Locations

Central contacts

Sheila Sprague, PhD

sprags@mcmaster.ca

Locations

Mass

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 25, 2026

Last verified

Jan, 2026

Keywords

  • Opioid
  • Pilot study
  • Musculoskeletal Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-25.