Pain Management
Conditions
Keywords
WALANT, Multimodal analgesia, Nonopioid pain management, VAS pain scores
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.
Interventions
30 pills of 500mg naproxen Q4hrs
DRUGAcetaminophen
30 pills of 500mg acetaminophen Q4hrs
10 pills of 5mg oxycodone Q4hrs as needed
Only used for breakthrough pain
Sponsors
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain Scores | 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. |
| Patient Satisfaction | From enrollment to the end of treatment at 7 days | Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18) |
| Total Opioid Usage | From enrollment to the end of treatment at 7 days | Will be reported in as morphine milligram equivalents (MMEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breakthrough Pain | From enrollment to the end of treatment at 7 days | Breakthrough pain will be reported as a binary outcome (Y/N) |
| Length of Treatment | 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 |
| Indication for WALANT surgery | 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 |
Countries
Puerto Rico
Contacts
Primary ContactJose I Acosta Julbe, MD
Backup ContactDaniel E. Deliz Jiménez, BSc
Outcome results
None listed