RecruitingPhase 4NCT06644261

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

Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial


Sponsor

University of Louisville

Enrollment

40 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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)

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Interventions

DRUGBupivacaine injection

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


Locations(1)

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, United States

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NCT06644261


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