NCT06917118

Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). The study groups are: * Control group: standard pain control with opioids * Experimental group: multimodal non-opioid pain control Study Outcomes are: * VAS pain scores (7 days), * Total opioid usage * Patient satisfaction * Adverse events We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Detailed description

The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Conditions

• Pain Management

Interventions

Type	Name	Description
DRUG	Oxycodone 5mg taken first	10 pills of 5mg oxycodone Q4hrs as needed
DRUG	Acetaminophen	30 pills of 500mg acetaminophen Q4hrs
DRUG	Naproxen Tablets, 500 mg	30 pills of 500mg naproxen Q4hrs
DRUG	OxyCODONE 5 mg Oral Tablet	Only used for breakthrough pain

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Puerto Rico