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NCT05783219 · ClinicalTrials.gov registry record · Phase 2
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
A Phase 2 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT05783219 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 39 participants.
The verdict
NCT05783219, a Phase 2 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes 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. The investigators 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.
Interventions
- OTHER Placebo
- DRUG Lidocaine patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05783219
The ClinicalTrials.gov registry entry for NCT05783219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05783219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05783219 about?
NCT05783219 is a clinical study titled "Lidocaine Patches Prior to Percutaneous Nerve Evaluation". The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes 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 ...
What is the current status of trial NCT05783219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2023-05-01. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT05783219?
The interventions under investigation include: Placebo (OTHER), Lidocaine patch (DRUG).
Who is sponsoring clinical trial NCT05783219?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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