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

NCT07750639 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2138972
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

opioid; gabapentin; Opioid Sparing; Opioid Stewardship; Non-Opioid Analgesics; Oxycodone; Multimodal Analgesia; Postoperative Pain; Upper Extremity Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  Through 2 weeks post-surgery

• 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.

  3 days post-surgery

Secondary Outcomes (4)

• Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery

  2 weeks post-surgery

• Number of Remaining Opioid Pills at 3 Days Post-Surgery

  3 days post-surgery

• Number of Participants Experiencing Medication-Related Adverse Effects

  Through 2 weeks post-surgery

• Number of Remaining Opioid Pills at 2 Weeks Post-Surgery

  2 weeks post-surgery

Study Arms (3)

High Pill-Count Multimodal Regimen

EXPERIMENTAL

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).

Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone

Standard Low-Volume Regimen

ACTIVE COMPARATOR

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).

Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone

Gabapentin Multimodal & Reduced Opioid Regimen

EXPERIMENTAL

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).

Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone; Drug: Gabapentin

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.

Gabapentin Multimodal & Reduced Opioid Regimen; High Pill-Count Multimodal Regimen; Standard Low-Volume Regimen

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.

Gabapentin Multimodal & Reduced Opioid Regimen; High Pill-Count Multimodal Regimen; Standard Low-Volume Regimen

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 Multimodal & Reduced Opioid Regimen; High Pill-Count Multimodal Regimen; Standard Low-Volume Regimen

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.

Gabapentin Multimodal & Reduced Opioid Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Able to read, write and understand English
• Undergoing hand, wrist, or elbow surgery

You may not qualify if:

• Inpatient surgery
• Patients with a history of illicit substance use/abuse, patients that were prescribed codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, or oxymorphone.
• Allergy or intolerance of NSAIDS, acetaminophen, gabapentin, or narcotics.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain, Postoperative

Interventions

Naproxen; Acetaminophen; Oxycodone; Gabapentin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)