跳至主要内容
临床试验/NCT05757011
NCT05757011招募中不适用

the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy: a Triple Blind Placebo Controlled RCT

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

研究概览

简要总结

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to:

Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered.

While patients randomized to group B will undergo TLH with pre-sacral nerve block.

详细描述

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered , then the uterus will be removed, and the operation will be terminated

While patients randomized to group B will undergo TLH with pre-sacral nerve block as follows:

Uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22G needle 2 to 3 cm below the umbilicus, injection of the SHP area which situated anterior to L5-S1 vertebral bodies, Caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (Marcaine®0.25% , Astra Zeneca, Egypt) will be administered. Following the injection of local anesthetic, patient will be placed from Trendelenburg position to horizontal position. The we will remove the uterus and trocars , and the operation will be terminated.

Data will be recorded in a case report form (CRF) and statistical analysis will be done.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2

排除标准

  • Previous presacral neurectomy
  • Concurrent surgical procedure other than salpingectomy and/or oophorectomy
  • Chronic narcotic consumption Inability to provide consent
  • Patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction).
  • Bleeding tendency (e.g. patient on anticoagulants, platelets disorders)
  • Intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)

结局指标

主要结局

● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

时间窗: 1hour

● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hassan Mohamed Mostafa

Principal Investigator

Ain Shams University

研究点 (2)

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