Clinical trial NCT06917118: Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
Official title: Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Keywords: WALANT
Multimodal analgesia
Nonopioid pain management
VAS pain scores
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS Pain Scores
timeFrame: From enrollment to the end of treatment at 7 days
measure: Patient Satisfaction
timeFrame: From enrollment to the end of treatment at 7 days
measure: Total Opioid Usage
timeFrame: From enrollment to the end of treatment at 7 days
Secondary outcomes:
measure: Breakthrough Pain
timeFrame: From enrollment to the end of treatment at 7 days
measure: Length of Treatment
timeFrame: From enrollment to the end of treatment at 7 days
measure: Indication for WALANT surgery
timeFrame: From enrollment to the end of treatment at 7 days
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Oncological Hospital
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Christian A. Foy, MD
role: PRINCIPAL_INVESTIGATOR
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