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

Not Applicable

Not yet recruiting

• Conditions: Pain Management
• Interventions: Drug: Oxycodone 5mg taken first; Drug: Acetaminophen; Drug: Naproxen Tablets, 500 mg; Drug: OxyCODONE 5 mg Oral Tablet

• Registration Number: NCT06917118
• Lead Sponsor: University of Puerto Rico

Brief 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-05-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients 21-70 years of age undergoing outpatient hand surgery
• Patients undergoing surgery with WALANT technique
• Patients who provide written informed consent

Exclusion Criteria

• Patients aged 20 and younger, or 71 and older
• Patient with chronic pain requiring opioid use
• Pregnant patients
• Patients who do not self-identify as Hispanic
• Patients with known allergy to the medication
• Patients with contraindications for the prescribed medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Postoperative opioid analgesia	Oxycodone 5mg taken first	10 pills of 5mg oxycodone Q4hrs as needed
Postoperative Opioid-sparing Multimodal analgesia	Acetaminophen	30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain
Postoperative Opioid-sparing Multimodal analgesia	Naproxen Tablets, 500 mg	30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain
Postoperative Opioid-sparing Multimodal analgesia	OxyCODONE 5 mg Oral Tablet	30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain

Primary Outcome Measures

Name	Time	Method
VAS Pain Scores	From enrollment to the end of treatment at 7 days	VAS pain scores will be assessed using a patient- completed VAS pain questionnaire until 7 days post-op. Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.
Patient Satisfaction	From enrollment to the end of treatment at 7 days	Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Total Opioid Usage	From enrollment to the end of treatment at 7 days	Will be reported in as morphine milligram equivalents (MMEs)

Secondary Outcome Measures

Name	Time	Method
Breakthrough Pain	From enrollment to the end of treatment at 7 days	Breakthrough pain will be reported as a binary outcome (Y/N)
Length of Treatment	From enrollment to the end of treatment at 7 days	Patients will be asked to report the number of days in which they used the provided pain control treatment
Indication for WALANT surgery	From enrollment to the end of treatment at 7 days	We will report the indication for treatment for each patient to include in the final analysis

Trial Locations

Locations (1)

Oncological Hospital; 🇵🇷 San Juan, Puerto Rico