An interventional study of Discharge pain medication prescription in Orthopaedic Related Pain (Musculoskeletal Pain), Opioid and Pain, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other
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.
This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.
494 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's planned enrollment of 100 is above the median of 68 across 347 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician.
Other: Discharge pain medication prescription
The control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician.
Other: 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.
Feasibility of patient enrollment and treatment allocation
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Participant enrollment * Feasibility of treatment allocation * Data collection methods (Proportion of participants with missing data) * Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)
Time frame: From enrollment to the end of the follow-up phase at 6 weeks
Opioid Use
Opioid usage assessed at 2 weeks and 6 weeks post-randomization
Time frame: From enrollment to the end of the follow-up at 6 weeks
Pain Interference
Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization.
Time frame: From enrollment to the end of the follow-up at 6 weeks
Plan to share: No
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Massachusetts General Hospital