Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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The study design will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 30 minutes prior to the procedure to placebo patch. Intervention and control patches will be in envelopes labeled with study number and located within the procedure area. A patch from the envelope corresponding to the patient will be placed by a medical assistant or co-investigator who is not associated with the PNE placement procedure 30 minutes prior to the procedure start. Number of voids and incontinence episodes per day prior to the PNE procedure will be recorded. A patch (intervention or control) will be removed by a medical assistant prior to provider entering the room in order to secure blinding. 1% lidocaine 10cc will be injected into the sacral procedure site for adequate pain relief. PNE procedure will then be performed. If inadequate analgesia is reported by the Patient during the procedure, additional injectable lidocaine will be administered in 5 cc increments, not to exceed 4.5 mg/kg of injectable lidocaine. The volume of injectable lidocaine used will be recorded. VAS pain scores prior to and immediately after procedure will be recorded. Patient Satisfaction Score, rate of successful PNE, rate of progression to SNS implantation, and amplitude of perineal stimulation of 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. The overall satisfaction score will be recorded at that time.

Official Title
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Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Conditions
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Overactive Bladder, Urge Incontinence, Fecal Incontinence

Intervention / Treatment
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* Drug: Lidocaine patch
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients undergoing sacral neuromodulation to manage their OAB with sacral neuromodulation trial with percutaneous nerve evaluation (PNE) without fluoroscopy. No contraindication to the use of lidocaine patch Age >18 years old Exclusion Criteria: Patients who are not candidates for SNM therapy Patients with contraindications to SNM including pregnancy Allergy to lidocaine or adhesives Chronic pain as an indication for the PNE procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center, double-blinded, placebo-controlled, randomized trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical lidocaine patch<br>4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure | Drug: Lidocaine patch<br>* 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure<br>|
| Placebo Comparator: Placebo<br>Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure | Other: Placebo<br>* Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale pain score | Visual Analog Scale pain score change (denoting the difference between pre- and post-procedural pain score). This scale ranges from 0-10. Higher Visual Analog Scale pain scores indicate worsening pain. | collected before and immediately after the PNE procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction | Satisfaction score collected after PNE procedure | immediately after PNE procedure | 
| Volume of injectable lidocaine used | The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure | collected after the PNE procedure | 
| Amplitude of perineal sensation | Amplitude of perineal sensation during the PNE procedure - collected on a likert scale | collected immediately after the PNE procedure | 
| Rate of successful PNE | Rate of successful stimulation and lead placement with the PNE procedure | collected immediately after the PNE procedure | 
| Rate of progression to permanent SNS implantation | The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator | to be assessed 3 months after the PNE procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine