Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Shoulder pain
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.
详细描述
Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laparoscopy for benign gynecologic diseases
- •patients aged 19-65 years
- •patients with american society of anesthesiology physical status I-II
- •patients obtaining written informed consent
排除标准
- •patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
- •patients with past history of pneumothorax or any pulmonary surgical history
- •patients with any shoulder surgery histories
- •patients who required to conversion to open surgery from laparoscopic surgery
- •patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
- •patients with inability to understand or express 10 point visual analogue scale
- •intrauterine pregnant women
结局指标
主要结局
Shoulder pain
时间窗: after two day of procedure
The pain score was evaluated by 10 point visual analogue scale.
次要结局
- Wound pain(after two day of procedure)
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital