Post-op Analgesia of Nail Unit Procedures

ConditionNail Diseases

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Miami

About this trial

The purpose of this study is to directly compare the efficacy of suzetrigine vs. oxycodone+acetaminophen vs. alternating acetaminophen/ibuprofen in controlling post-operative pain after the following nail unit procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients age 18+ able to understand and provide written consent in English or Spanish who present to Dr. Brian Morrison's clinic at the University of Miami and are undergoing a nail unit procedure.

Disqualifiers

Patients under the age of 18 or adults unable to consent.

Patients who are pregnant or incarcerated.

Trial design

Design model

Parallel

Treatments tested in this trial

Suzetrigine
Drug
Participants will receive two 50 mg oral tablets on day 1, followed by 50 mg oral tablets every 12 hours for 5 days
Oxycodone/Acetaminophen
Drug
Participants will receive oral oxycodone 5 mg/acetaminophen 325 mg (Percocet®) as a fixed-dose combination tablet every 6 hours for 5 days, beginning on the day of the nail procedure.
Acetaminophen
Drug
Participants will receive acetaminophen 650 mg orally every 6 hours, alternating with ibuprofen, for 5 days beginning on the day of the nail procedure.
Ibuprofen
Drug
Participants will receive ibuprofen 400 mg orally every 6 hours, alternating with acetaminophen, for 5 days beginning on the day of the nail procedure.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Suzetrigine GroupExperimental treatment 1 intervention

Group B: Oxycodone + Acetaminophen Combination GroupActive comparator 1 intervention

Group C: Alternating Acetaminophen/Ibuprofen GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in Post-Operative Pain Intensity

Pot-operative pain intensity measured using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst possible pain; higher scores indicate greater pain following nail unit procedures.

Time frame

24 hours post nail procedure, 48 hours post nail procedure, 72 hours post nail procedure

Sponsors and contacts

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

University of Miami

Lead sponsor

Source ClinicalTrials.gov

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