Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: A Double-Blind, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Visual analogue pain score
研究概览
简要总结
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.
详细描述
Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient acceptance.
- •Body mass index < 35 kg/m
- •Adult patients with chronic pelvic and perineal pain due to pelvic cancer.
- •Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.
排除标准
- •Uncooperative patient.
- •Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.
研究组 & 干预措施
Laparoscopic Presacral Neurectomy
The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.
干预措施: Laparoscopic Presacral Neurectomy (Procedure)
Fluoroscopically guided Superior Hypogastric Neurolysis
The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4.
干预措施: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis (Procedure)
结局指标
主要结局
Visual analogue pain score
时间窗: At the end of the first month after the procedure.
The percentage of patients who achieved \> 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month.
次要结局
- Daily analgesic requirements(At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.)
- Associated adverse events(At the end of the first month after the procedure.)