Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute change in Visual Analog Scale (VAS) for pain
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients will be unable to remain masked to treatment intervention. Procedurists will also be unable to remain masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Bupivacaine injection (Drug)
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.
干预措施: Bupivacaine injection (Drug)
结局指标
主要结局
Absolute change in Visual Analog Scale (VAS) for pain
时间窗: 6 weeks
VAS will be obtained at baseline, post-procedure, weekly until 6 weeks, scale is 0-100 mm with higher scores indicated more pain severity
次要结局
未报告次要终点
研究者
Sean Francis, MD
OBGYN Department Chair, Fellowship Director Urogynecology
University of Louisville