Oncological Hospital
San Juan, PR, 00935, Puerto Rico
NCT Number: NCT06917118
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.
Trial opening soon.
Get Notified21 year–70 year
All sexes
Interventional
Not applicable
San Juan, PR, 00935, 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 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 pills of 5mg oxycodone Q4hrs as needed
30 pills of 500mg acetaminophen Q4hrs
30 pills of 500mg naproxen Q4hrs
Only used for breakthrough pain
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.
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)
Time frame: From enrollment to the end of treatment at 7 days
Will be reported in as morphine milligram equivalents (MMEs)
Time frame: From enrollment to the end of treatment at 7 days
Breakthrough pain will be reported as a binary outcome (Y/N)
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
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
Contact information is provided by the study sponsor or research team.
Daniel E. Deliz Jiménez, BSc
CONTACT
Jose I Acosta Julbe, MD
CONTACT
University of Puerto Rico
Other
Acronym: WALANT
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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