Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-01 @ 3:06 AM
Study NCT ID:
NCT06644261
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
Sponsor:
University of Louisville
Organization:
Study Overview
Official Title:
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: