Actively Recruiting
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
Led by Massachusetts General Hospital · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Underwent a major operative orthopaedic procedure
You will not qualify if you...
- Contraindication for NSAIDs
- Preoperative chronic opioid use (more than 14 days and average of more than 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 with maintaining follow-up
- 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
- Did not provide informed consent
- Other reason to exclude the patient as approved by the Principal Investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mass
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Arun Aneja, MD, PhD
CONTACT
S
Sheila Sprague, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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