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NCT Number: NCT05783219

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 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.

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Key information

Conditions

Overactive Bladder Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine patch

Drug

4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure

Placebo

Other

Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure

Primary outcomes

  1. Visual Analog Scale Pain Score

    Time frame: collected before and immediately after the PNE procedure

    Visual Analog Scale pain score (indicating the difference between pre and post-procedural pain scores). The scores in question were 100 mm visual analog scale pain scores. This scale ranges from 0-100mm. Higher 100mm Visual Analog Scale pain scores indicate worsening pain.

Secondary outcomes

  1. Overall Satisfaction

    Time frame: immediately after PNE procedure

    Satisfaction score collected after PNE procedure. This was accomplished by a Likert scale ranging from "not satisfied" to "somewhat satisfied" to "moderately satisfied" to "quite a bit satisfied". with increasing answers indicating increased satisfaction with the Percutaneous nerve evaluation procedural experience.

  2. Volume of Injectable Lidocaine Used

    Time frame: collected after the PNE procedure

    The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure

  3. Amplitude of Perineal Sensation.

    Time frame: collected immediately after the PNE procedure

    Amplitude of perineal sensation during the PNE procedure. This was accomplished with a 100mm Visual analog scale score. This scale had 0mm indicating no sensation through 100mm indicating the most sensation one has ever felt. This was assessed during percutaneous nerve evaluation stimulation. The aim of the percutaneous nerve evaluation procedure is to achieve high sensation in the region of interest during stimulation - a proxy for appropriate lead placement. Thus, high values on this 100mm Visual analog scale indicate a better outcome.

  4. Rate of Successful PNE

    Time frame: collected immediately after the PNE procedure

    Rate of successful stimulation and lead placement with the PNE procedure

  5. Rate of Progression to Permanent SNS Implantation

    Time frame: to be assessed 6 months after the PNE procedure

    The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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