Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644261
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia a Prospective Noninferiority Randomized Controlled Trial
Sponsor:
None
Organization:
None
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:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 TG 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 TG 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None