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Opioid Abuse (Disorder)PainMental healthAddictionDrugPhase 4

What this study is

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.

What's being tested

  • Naproxen

    Intervention · 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

    Intervention · 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

    Intervention · 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

    Intervention · 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

Official title
Optimizing Multimodal Pain Regimens: Evaluating the Analgesic Effect of Pill Quantity and Gabapentin in Reducing Opioid Dependency
Sponsor
AdventHealth
Conditions
Opioid Abuse (Disorder) · Opioid Analgesia · Opioid Analgesic Adverse Reaction · Opioid Consumption
Enrolling
300 people
Starts
2024-08-01
Est. completion
2027-12-30
Design
Single-blind, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗