The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Shoulder pain evaluated by 10 point visual analogue scale
研究概览
简要总结
The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.
详细描述
Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic 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
- •pregnant women
研究组 & 干预措施
Control
Passive deflation of residual carbon dioxide
干预措施: Passive Deflation (Procedure)
Normal Saline Instillation
Instillation of isotonic normal saline in the sub-diaphragmatic region
干预措施: Normal Saline Instillation (Procedure)
Combined Intervention
Normal Saline Instillation + Pulmonary Recruitment
干预措施: Normal Saline Instillation + Pulmonary Recruitment (Procedure)
结局指标
主要结局
Shoulder pain evaluated by 10 point visual analogue scale
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 evaluated by 10 point visual analogue scale(after two day of procedure)
研究者
Kyoungho Ryu
Clinical assistant professor
Kangbuk Samsung Hospital