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临床试验/NCT03069586
NCT03069586Unknown不适用

The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy

General Hospital Groeninge2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年5月1日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
pain relief during the first 24 hours
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

详细描述

Two groups:

  1. A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg)
  2. A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

研究设计

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

入排标准

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

入选标准

  • •ASA I and II

排除标准

  • •refusal to give consent
  • •cholecystitis
  • •BMI above 35
  • •intolerance to one of the pain medication
  • •pregnancy

结局指标

主要结局

pain relief during the first 24 hours

时间窗: 24hours

VAS (0-10)

次要结局

  • Total analgesic use during the first 24 hours(24hours)
  • Length of hospital stay(2 days)
  • Recovery after 48 hours(48 hours)

研究者

发起方
General Hospital Groeninge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Casier Isabelle

Doctor

General Hospital Groeninge

研究点 (2)

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