Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07265557
Status
Recruiting
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Conditions

  • Opioid
  • Orthopaedic Related Pain (Musculoskeletal Pain)
  • Pain
  • Pilot Study

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discharge pain medication prescription — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
MassBostonMassachusetts02114
Arun Aneja, MD, PhD
[email protected]
617-726-6546

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