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

NCT06917118 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

  • Pain Management

Interventions

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

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Christian A. Foy, MD · University of Puerto Rico Medical Sciences Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-11-01
Completion
2025-12-01

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917118 on ClinicalTrials.gov