NCT07265557 · Massachusetts General Hospital
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
What this study is about
This is a single-center, pilot randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients 18 years of age or older
- Underwent a major operative orthopaedic procedure
Exclusion criteria
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations