drugset / Trial / NCT07750639

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

NCT07750639 ↗

Phase 4 Enrolling by invitation 300 enrolled AdventHealth
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2024-08-01
Primary completion
2027-11-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg Oral
Subject Acetaminophen Small molecule 650 mg Oral
Subject Gabapentin Unknown 300 mg Oral
Subject Naproxen Small molecule 250 mg Oral
Subject Naproxen Small molecule 500 mg Oral
Subject Oxycodone Other / unclassified 5 mg Oral