Actively Recruiting
A Pilot Randomized Controlled Trial Comparing 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
4 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
Researchers are evaluating the feasibility of a larger study comparing two post-operative pain medication protocols at discharge for patients undergoing major orthopaedic surgery. This pilot randomized controlled trial aims to compare opioid-free discharge prescriptions to usual care that includes opioids. The study focuses on the design and feasibility of a definitive trial by assessing enrollment, adherence, and data collection metrics. Participants will be randomly assigned to receive either a discharge pain medication prescription without opioids or the usual care prescription that includes opioids. The specific medications, such as ibuprofen, paracetamol, ketorolac, or opioids, and their dosages are determined by the treating physician. The study plans to enroll at least 100 patients across various orthopaedic subspecialties including trauma, arthroplasty, foot and ankle, spine, and sports medicine. During the study, researchers will monitor feasibility from enrollment through a 6-week follow-up period. They will also compare opioid use and pain interference between the two groups. Patients will be assessed for opioid consumption and how pain affects their daily activities. This pilot trial helps prepare for a larger study while ensuring patient safety and data quality throughout the process.
CONDITIONS
Brief 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 (use of 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 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 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Hospital stay until discharge
Participants undergo major orthopaedic surgery and receive immediate post-operative care while hospitalized.
1 hospital stay
Duration - From discharge until 6 weeks post-discharge
Participants are randomized to receive either a discharge pain medication prescription without opioids or usual care discharge pain medication with opioids as determined by their treating physician.
1 discharge visit and follow-up assessments up to 6 weeks
Duration - 6 weeks after discharge
Participants are followed for 6 weeks after discharge to monitor opioid use and pain interference.
Follow-up visits or assessments during 6 weeks post-discharge
Trial Site Locations
Total: 1 location
1
Mass
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Arun Aneja, MD, PhD
S
Sheila Sprague, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here