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NCT Number: NCT06917118

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone 5mg taken first

Drug

10 pills of 5mg oxycodone Q4hrs as needed

Acetaminophen

Drug

30 pills of 500mg acetaminophen Q4hrs

Naproxen Tablets, 500 mg

Drug

30 pills of 500mg naproxen Q4hrs

OxyCODONE 5 Mg Oral Tablet

Drug

Only used for breakthrough pain

Primary outcomes

  1. 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.

  2. 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)

  3. Total Opioid Usage

    Time frame: From enrollment to the end of treatment at 7 days

    Will be reported in as morphine milligram equivalents (MMEs)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel E. Deliz Jiménez, BSc

CONTACT

[email protected]

+1 7872332369

Jose I Acosta Julbe, MD

CONTACT

[email protected]

+1 7873794119

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Acronym: WALANT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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