Clinical trial NCT06644261: Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
Official title: Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pudendal Neuralgia
Chronic Pelvic Pain Syndrome
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel prospective randomized non-inferiority trial with option for cross-over
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility 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)

Primary outcomes:
measure: Absolute change in Visual Analog Scale (VAS) for pain
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
state: Kentucky
Study officials:
References: