临床试验/NCT04549818

NCT04549818Unknown不适用

Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?

Assiut University0 个研究点目标入组 44 人开始时间: 2020年9月10日最近更新: 2020年9月16日

适应症

试验速览

阶段: 不适用
发起方: Assiut University
入组人数: 44
主要终点: The change of intensity of pain

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.

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: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age, 18-70
•Pain localized to the pelvic and perineal region
•The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
•The intensity of pain assessed by VAS (visual analogue pain scale) > 7
•Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root

排除标准

•Coagulopathy
•Infection at site of maneuver
•Abnormal Psychological behavior that interfere with integrity of obtained data

结局指标

主要结局

The change of intensity of pain

时间窗: The outcome will be measured at day 15 postoperatively.

The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain

次要结局

未报告次要终点

研究者

发起方

Assiut University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Diab Fuad Hetta

anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt

Assiut University

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