Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurel Carbone, MD | Contact | 502-588-7660 | laurel.carbone@louisville.edu | |
| Sean Francis, MD | Contact | 502-588-7660 | sean.francis@louisville.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery | Recruiting | Louisville | Kentucky | 40202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060545 | Pudendal Neuralgia |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Parallel prospective randomized non-inferiority trial with option for cross-over
Not provided
Not provided
Patients will be unable to remain masked to treatment intervention. Procedurists will also be unable to remain masked.
|
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |