Overview

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 1 hour prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to undergo a medically indicated percutaneous nerve evaluation (PNE). VAS pain score, The volume of injectable lidocaine used, Patient Satisfaction Score, rate of successful PNE (defined as successful placement of wire in the S3 spinal foramen), and the amplitude of perineal stimulation on a Likert scale will be collected immediately after the procedure. Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be recorded at that time. Rate of progression to Sacral nerve stimulator implantation will be collected. We hypothesize that patients in the lidocaine patch group will experience significantly less pain at the time of PNE as measured by a lower change in VAS pain score when compared with the control group.
Phase:
Phase 2
Details
Lead Sponsor:
University of Louisville
Treatments:
Lidocaine