Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
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
- 是
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
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
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
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
Seda Yuksel Simsek
Gynecology Specialist
Baskent University
