An interventional study of Oxycodone 5mg taken first and Acetaminophen in Pain Management, sponsored by University of Puerto Rico. Not yet recruiting at 1 site in Puerto Rico. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of Puerto Rico · Not applicable, Interventional, and Treatment
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:
Study Outcomes are:
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.
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.
University of Puerto Rico is the lead sponsor of 45 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 pills of 5mg oxycodone Q4hrs as needed
Drug: Oxycodone 5mg taken first
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
Drug: Acetaminophen · Drug: Naproxen Tablets, 500 mg · Drug: OxyCODONE 5 mg Oral Tablet
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
VAS Pain Scores
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
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
Total Opioid Usage
Will be reported in as morphine milligram equivalents (MMEs)
Time frame: From enrollment to the end of treatment at 7 days
Breakthrough Pain
Breakthrough pain will be reported as a binary outcome (Y/N)
Time frame: From enrollment to the end of treatment at 7 days
Length of Treatment
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
Indication for WALANT surgery
We will report the indication for treatment for each patient to include in the final analysis
Time frame: From enrollment to the end of treatment at 7 days
Plan to share: No — Individual Participant Data (IPD) will only be used internally by the study PI and primary investigators.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Puerto Rico