Health TrialsbyHealthPanel

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

ConditionPain Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorUniversity of Puerto Rico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 21-70 years of age undergoing outpatient hand surgery

Patients undergoing surgery with WALANT technique

Patients who provide written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxycodone 5mg taken first

    Drug

    10 pills of 5mg oxycodone Q4hrs as needed

  • Acetaminophen

    Drug

    30 pills of 500mg acetaminophen Q4hrs

  • Naproxen Tablets, 500 mg

    Drug

    30 pills of 500mg naproxen Q4hrs

  • OxyCODONE 5 mg Oral Tablet

    Drug

    Only used for breakthrough pain

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard Postoperative opioid analgesiaActive comparator 1 intervention
Group B: Postoperative Opioid-sparing Multimodal analgesiaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

Total Opioid Usage

Will be reported in as morphine milligram equivalents (MMEs)

Time frame
From enrollment to the end of treatment at 7 days

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Puerto Rico

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: