Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia

NCT06644261 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB #24.0319
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities. The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.

Conditions

Pudendal Neuralgia; Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Absolute change in Visual Analog Scale (VAS) for pain

  VAS will be obtained at baseline, post-procedure, weekly until 6 weeks, scale is 0-100 mm with higher scores indicated more pain severity

  6 weeks

Study Arms (2)

Transvaginal pudendal nerve block

OTHER

Participants in this arm will receive 10 mL bupivacaine injected into bilateral pudendal nerves via transvaginal approach. This is performed by palpating 1 cm superior and medial to the ischial spine. Participants will receive an injection each 2 weeks, for a total of 3 injections over 6 weeks.

Drug: Bupivacaine injection

Fluoroscopy guided pudendal nerve block

OTHER

Participants in this arm will receive 5 mL bupivacaine injected into bilateral pudendal nerves via fluoroscopic guided trans gluteal approach. They will receive one injection over the 6-week duration.

Drug: Bupivacaine injection

Interventions

Bupivacaine injection DRUG

Transvaginal: Palpation 1 cm superior and medial to ischial spine to locate pudendal nerve. 22 gauge spinal needle with trumpet will be placed at this location. Upon negative aspiration, 10 mL of 0.25% bupivacaine will be injected bilaterally. Fluoroscopic: Anesthesia Pain medicine fluoroscopy guided injection of 5 mL 0.25% bupivacaine bilaterally in the area of the pudendal nerve based on surrounding landmarks

Fluoroscopy guided pudendal nerve block; Transvaginal pudendal nerve block

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Laurel Carbone, MD

CONTACT

502-588-7660; laurel.carbone@louisville.edu

Sean Francis, MD

CONTACT

502-588-7660; sean.francis@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be unable to remain masked to treatment intervention. Procedurists will also be unable to remain masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN Department Chair, Fellowship Director Urogynecology

Model Details: Parallel prospective randomized non-inferiority trial with option for cross-over

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: June 27, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)