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

NCT ID: NCT06644261

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2029-07-01

Brief Summary

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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

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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

Conditions

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Pudendal Neuralgia Chronic Pelvic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel prospective randomized non-inferiority trial with option for cross-over
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Patients will be unable to remain masked to treatment intervention. Procedurists will also be unable to remain masked.

Study Groups

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Transvaginal pudendal nerve block

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.

Group Type OTHER

Bupivacaine injection

Intervention Type 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

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.

Group Type OTHER

Bupivacaine injection

Intervention Type 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

Interventions

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Bupivacaine 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Sean Francis, MD

OBGYN Department Chair, Fellowship Director Urogynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laurel Carbone, MD

Role: CONTACT

Phone: 502-588-7660

Email: [email protected]

Sean Francis, MD

Role: CONTACT

Phone: 502-588-7660

Email: [email protected]

Facility Contacts

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Laurel Carbone, MD

Role: primary

Other Identifiers

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IRB #24.0319

Identifier Type: -

Identifier Source: org_study_id