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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth
Study ID
NCT07750639
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Opioid Abuse (Disorder)
  • Opioid Analgesia
  • Opioid Analgesic Adverse Reaction
  • Opioid Consumption

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Naproxen — DRUG
    An oral nonsteroidal anti-inflammatory drug (NSAID) administered postoperatively for 7 days to provide baseline anti-inflammatory analgesia. Dosing varies by arm assignment (250 mg tablets vs. 500 mg tablets) to evaluate the impact of physical pill burden.
  • Acetaminophen — DRUG
    An oral non-opioid analgesic administered postoperatively 4 times daily for 7 days. Dosing varies by arm assignment (325 mg tablets vs. 650 mg tablets) to evaluate the impact of physical pill burden.
  • oxycodone — DRUG
    An oral short-acting mu-opioid receptor agonist administered postoperatively as needed for breakthrough pain. Total pill quantity varies by arm assignment, providing either a standard 3-day course (12 pills total) or a reduced 1.5-day course (6 pills total).
  • Gabapentin — DRUG
    An oral anticonvulsant/gabapentinoid administered postoperatively at 300 mg twice daily for 7 days as part of a multimodal non-opioid strategy to enable a shortened opioid course.

Study Details

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.

Key Dates

First listed
Aug 6, 2026
Start date
Aug 1, 2024
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Oct 14, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Pill-Count Multimodal Regimen
    Participants receive a standard cumulative daily dose of non-opioid medications split into lower individual strengths to increase the physical pill count and dosing frequency. The regimen consists of Naproxen 250 mg (2 pills twice daily for 7 days), Acetaminophen 325 mg (2 pills 4 times daily for 7 days), and a standard course of Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
  • Active Comparator: Standard Low-Volume Regimen
    Participants receive a standard cumulative daily dose of non-opioid medications utilizing standard individual pill strengths, resulting in a lower physical pill burden. The regimen consists of Naproxen 500 mg (1 pill twice daily for 7 days), Acetaminophen 650 mg (1 pill 4 times daily for 7 days), and a standard course of Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
  • Experimental: Gabapentin Multimodal & Reduced Opioid Regimen
    Participants receive a multimodal regimen that incorporates gabapentin alongside standard non-opioid medications, allowing for a 50% reduction in the total physical quantity of prescribed opioids. The regimen consists of Naproxen 500 mg (1 pill twice daily for 7 days), Acetaminophen 650 mg (1 pill 4 times daily for 7 days), Gabapentin 300 mg (1 pill twice daily for 7 days), and a shortened course of Oxycodone 5 mg (1 pill 4 times daily for 1.5 days; 6 pills total).

Primary Outcome Measure

Number of Participants Requesting an Additional Postoperative Pain Medication Refill [ Time Frame: Through 2 weeks post-surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealthOrlandoFlorida32827-

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By research site
AdventHealth· Orlando, FL

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