Comparing two methods for pudendal nerve block in pelvic pain treatment
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial
This study is testing two different ways to give a nerve block to see which one helps women with pelvic pain feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06644261 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of two different approaches for administering a pudendal nerve block in women suffering from pudendal neuralgia or chronic pelvic pain. Participants will be randomized to receive either a transvaginal pudendal nerve block without imaging or a fluoroscopy-guided trans gluteal pudendal nerve block. The primary outcome will be measured by changes in pain levels using the Visual Analog Scale over a six-week period. Secondary objectives include assessing patient satisfaction and the emotional impact of pain through validated questionnaires.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with a diagnosis of pudendal neuralgia or chronic pelvic pain lasting at least three months.
Not a fit: Patients with contraindications to pudendal nerve block or recent pelvic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for pain relief in women suffering from pudendal neuralgia.
How similar studies have performed: While there are no published randomized controlled trials comparing these specific approaches, the concept of imaging-guided nerve blocks has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women \>18 years * English speaking/reading * Diagnosis of pudendal neuralgia OR chronic pelvic pain with pain in the distribution of the pudendal nerve for 3 months or longer * Minimum pain/bother score of 4/10 * Desire for pudendal nerve block Exclusion Criteria: * Contraindication to pudendal nerve block (examples: skin or vaginal infection, bupivacaine allergy, uncorrected coagulopathy) * Pregnant or intending to become pregnant during the study * Pudendal nerve block from any route within the last 3 months * Major pelvic surgery within the last 3 months (examples: hysterectomy, prolapse repair, midurethral sling) * Neurologic disease affecting the perineum (examples: spinal cord injury, multiple sclerosis)
Where this trial is running
Louisville, Kentucky
- University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Laurel Carbone, MD
- Email: laurel.carbone@louisville.edu
- Phone: 502-588-7660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.