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临床试验/NCT03623399
NCT03623399Unknown不适用

Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score

Seda Yuksel Simsek2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2018年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
195
试验地点
2
主要终点
postoperative pain scores

研究概览

简要总结

Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.

详细描述

In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • benign gynecologic pathologies which requires laparoscopic surgery

排除标准

  • patients who has malign gynecologic pathologies

研究组 & 干预措施

15 mmhg-15mmhg

No Intervention

Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg.

15 mmhg-12 mmhg

Other

Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.

Low gas pressure laparoscopy

干预措施: low gas pressure laparoscopy (Procedure)

12 mmhg-12 mmhg

Other

Abdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.

Low gas pressure laparoscopy

干预措施: low gas pressure laparoscopy (Procedure)

结局指标

主要结局

postoperative pain scores

时间窗: Postoperative 6 th hour

Difference between pain scores of participitants according to differing gas pressures applied.

次要结局

未报告次要终点

研究者

发起方
Seda Yuksel Simsek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seda Yuksel Simsek

Gynecology Specialist

Baskent University

研究点 (2)

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