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NCT Number: NCT06644261

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

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.

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Key information

Conditions

Pudendal Neuralgia Chronic Pelvic Pain Syndrome Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Laurel Carbone, MD

CONTACT

[email protected]

502-588-7660

About this study

Primary objective:

Determine the efficacy of pain relief comparing the change in Visual Analog Scale (VAS) from baseline to 6 weeks in women randomized to Transvaginal PNB (without imaging) versus Trans gluteal fluoroscopy-guided PNB.

Upon completion of 6-week follow-up, participants will be given the option to crossover to the alternative treatment arm

Secondary Objectives:

Characterize the effect of either pudendal nerve block approach using the following validated questionnaires

  • PROMIS-29 (degree of pain intensity and bother across health domains)
  • Pain catastrophizing scale (emotional and cognitive impact of pain)
  • Short-form McGill (qualitative pain)
  • Patient satisfaction with medical care
  • Baseline demographics
  • Baseline VAS
  • Adverse events
  • Determine the time to peak pain relief and duration of injection pain relief

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

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

Primary outcomes

  1. Absolute change in Visual Analog Scale (VAS) for pain

    Time frame: 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurel Carbone, MD

CONTACT

[email protected]

502-588-7660

Sean Francis, MD

CONTACT

[email protected]

502-588-7660

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Oct 16, 2024
Registry last updated
Dec 18, 2024

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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