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

This randomized controlled trial evaluates the efficacy of multimodal analgesic regimens to maximize postoperative pain relief while minimizing opioid dependency in patients undergoing hand, wrist, or elbow surgery. The study explores two distinct clinical concepts: first, whether changing the physical pill burden (quantity and frequency) of non-opioid medications alters perceived pain management; and second, whether integrating gabapentin permits a 50% reduction in initial opioid prescriptions without compromising analgesia. A total of around 251 adult participants will be randomized with an equal allocation probability into one of three standard-of-care medication arms:

Group 1 (High Pill Count Non-Opioid): Naproxen 250 mg (2 pills twice daily for 7 days; 1,000 mg/day) + Acetaminophen 325 mg (2 pills 4 times daily for 7 days; 2,600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).

Group 2 (Low Pill Count Non-Opioid / Control): Naproxen 500 mg (1 pill twice daily for 7 days; 1,000 mg/day) + Acetaminophen 650 mg (1 pill 4 times daily for 7 days; 2,600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).

Group 3 (Gabapentin Multimodal / Reduced Opioid): Naproxen 500 mg (1 pill twice daily for 7 days; 1,000 mg/day) + Acetaminophen 650 mg (1 pill 4 times daily for 7 days; 2,600 mg/day) + Gabapentin 300 mg (1 pill twice daily for 7 days; 600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 1.5 days; 6 pills total).

Primary Objectives and Comparisons:

Analgesic Effect of Non-Opioid Pill Volume: By comparing Group 1 and Group 2, researchers will evaluate if a higher physical volume of non-opioid pills taken at a greater dosing frequency provides superior self-reported pain control compared to a lower pill volume, despite both groups receiving identical cumulative daily milligram dosages of non-opioids and opioids.

Opioid Reduction via Gabapentin Integration: By comparing Group 3 to Group 2, researchers will evaluate if the addition of gabapentin provides sufficient additive analgesia to allow for a 50% reduction in the post-operative oxycodone supply (6 pills vs. 12 pills) without increasing patient pain scores or the rate of subsequent prescription refill requests.

Data Collection Schedule:

Participant outcomes will be tracked during structured follow-up telephone interviews conducted at 3 days and 2 weeks post-surgery. The data points collected at these intervals include patient-reported pain scores (0-10 visual scale), the exact number of remaining opioid pills, occurrences of medication-related adverse effects, and records of any formal postoperative refill requests.

Primary Outcome Measures

1. Number of Participants Requesting an Additional Postoperative Pain Medication Refill
   A binary tracking (yes/no) of whether a participant formally contacts the investigator or clinical staff to request a prescription refill for postoperative pain management during the study period.
2. Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery
   Patient-reported pain will be measured using a standard visual scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain possible". Higher scores indicate a worse pain outcome.

Secondary Outcome Measures

1. Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery
   Patient-reported pain will be measured using a standard visual scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain possible". Higher scores indicate a worse pain outcome.
2. Number of Remaining Opioid Pills at 3 Days Post-Surgery
   The physical count of remaining 5 mg oxycodone pills will be reported by the participant via a follow-up phone call to determine total consumption.
3. Number of Participants Experiencing Medication-Related Adverse Effects
   The frequency of participants reporting expected adverse events associated with the prescribed multimodal regimens (e.g., gastrointestinal issues for naproxen; liver toxicity concerns for acetaminophen; dizziness, drowsiness, or nausea for oxycodone and gabapentin).
4. Number of Remaining Opioid Pills at 2 Weeks Post-Surgery
   The physical count of remaining 5 mg oxycodone pills will be reported by the participant via a follow-up phone call to determine final consumption.