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临床试验/NCT02976571
NCT02976571Unknown不适用

Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

Wolfson Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Pain level during movement, 8 hours after laparoscopy

研究概览

简要总结

A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

详细描述

4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Elective laparoscopy

排除标准

  • Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours

研究组 & 干预措施

Placebo+Placebo

Placebo Comparator

Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

干预措施: Bupivacaine (Drug)

Sub cutaneous+Intraperitoneal

Experimental

Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine

干预措施: Bupivacaine (Drug)

Sub cutaneous+Placebo

Active Comparator

Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%

干预措施: Bupivacaine (Drug)

Placebo+Intraperitoneal

Active Comparator

Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Pain level during movement, 8 hours after laparoscopy

时间窗: 8 hours

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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