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Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill Quantity

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later across 2 updates Sep 30, 2026 → Nov 30, 2027
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from AdventHealth

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Nov 30, 2026 to Nov 30, 2027
    • Enrollment increased: 260 → 300 participants
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Secondary endpoints reordered
  2. Notable Primary endpoint(s) modified Show 4 more changesShow less
    • Primary completion pushed from Sep 30, 2026 to Nov 30, 2026
    • Study completion pushed from Oct 14, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 4 to 5
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
31 trials monitored
See 2 trials at risk
The goal of this clinical trial is to evaluate strategies for optimizing postoperative multimodal pain regimens and reducing opioid dependency in patients undergoing upper extremity surgery. The main questions it aims to answer are: * Does increasing the total physical quantity of non-opioid pills (Naproxen and Acetaminophen) prescribed in smaller individual doses alter a patient's self-reported postoperative pain scores, even when the total daily milligram dosage remains identical? * Does combining the non-opioid medication gabapentin with a significantly lower initial quantity of prescribed opioid pills (oxycodone) provide comparable pain relief and reduce the rate of subsequent medication refill requests? Researchers will compare three groups of participants receiving distinct standard-of-care pain management regimens to see how pill volume variations and gabapentin integration affect recovery. Participants will: * Be randomized into one of three standard postoperative pain medication groups varying in non-opioid pill counts or featuring a shortened opioid course combined with gabapentin. * Report their pain scores, medication adverse effects, and any prescription refill requests during follow-up phone calls at 3 days and 2 weeks post-surgery. * Track and report the remaining number of opioid pills they have left at the time of the follow-up calls.
Trial Details
NCT Number NCT07750639
Lead Sponsor AdventHealth
Conditions
(from sponsor)
Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction, Opioid Consumption
Related terms Opioid-Related Disorders, Postoperative Pain
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov