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

University of Puerto Rico (UPR)

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Drug: Naproxen Tablets, 500 mg; Drug: Acetaminophen; Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxycodone 5mg taken first

Study type: Interventional

Funder types: Other

Identifiers

NCT06917118

2501339638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Standard Postoperative opioid analgesia

Active Comparator group

Description:

10 pills of 5mg oxycodone Q4hrs as needed

Treatment:

Drug: Oxycodone 5mg taken first

Postoperative Opioid-sparing Multimodal analgesia

Experimental group

Description:

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

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Drug: Naproxen Tablets, 500 mg

Drug: Acetaminophen