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

March 31, 2025 updated by: Daniel Deliz, University of Puerto Rico

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Postoperative opioid analgesia
10 pills of 5mg oxycodone Q4hrs as needed
Drug: Oxycodone 5mg taken first
10 pills of 5mg oxycodone Q4hrs as needed
Experimental: Postoperative Opioid-sparing Multimodal analgesia
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Pain Scores
Time Frame: 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.
From enrollment to the end of treatment at 7 days
Patient Satisfaction
Time Frame: From enrollment to the end of treatment at 7 days
Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
From enrollment to the end of treatment at 7 days
Total Opioid Usage
Time Frame: From enrollment to the end of treatment at 7 days
Will be reported in as morphine milligram equivalents (MMEs)
From enrollment to the end of treatment at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breakthrough Pain
Time Frame: From enrollment to the end of treatment at 7 days
Breakthrough pain will be reported as a binary outcome (Y/N)
From enrollment to the end of treatment at 7 days
Length of Treatment
Time Frame: 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
From enrollment to the end of treatment at 7 days
Indication for WALANT surgery
Time Frame: 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
From enrollment to the end of treatment at 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Investigators

  • Principal Investigator: Christian A. Foy, MD, University of Puerto Rico Medical Sciences Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Estimated)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

April 8, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2501339638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will only be used internally by the study PI and primary investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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