Comparison of effect of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS score of shoulder pain at 4 hr, 8 hr, 24 hr, 7day. rescue analgesic used and dose
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is the preferred surgical procedure for gallstone disease. About 21% to 80 %patients undergoing LC suffer fromshoulder pain (SP) in the early post-operative period, which canlead to patient dissatisfaction and discomfort. The most common etiology of shoulder pain is due tothe stretching of peritoneum and diaphragmatic irritation by the carbon dioxidepneumoperitoneum used for LC .
Pneumoperitoneum is created with the carbondioxide to inflate the abdomen. This allows the visualisationof internal organs and provides adequate working space for instrument manoeuvrability.Intra-abdominal pressure of 12–16 mm of Hg is accepted as standardintra-peritoneal pressure for adequate working space and organ visualisation. Increased intraabdominal pressure may also have negative implications oncardiovascular, pulmonary, and intraabdominal organ functionings. Attempts are beingmade to reduce the incidence of shoulder pain by keeping the intra-abdominalpressure at a lower level. In literature, low-pressure PNP is generally definedas an intraabdominal pressure of 6–10 mmHg.11 The main criticism oflow pressure pneumoperitoneum is its ability to provide adequate surgicalexposure and hence its safety.
Thepresent randomised study is designed to evaluate the impact of intra-abdominalpressure on post-operative pain and surgeons’ satisfaction in LC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patients undergoing laparoscopic cholecystectomy.
排除标准
- •1.Patients with BMI > 30 kg/m2 2.ASA grade III and above 3.History of complicated gallstone diseases like cholangitis, pancreatitis, 4.History of previous malignancy or history of multiple abdominal surgery 5.Known shoulder disease 6.Patients who refuse to give informed consent 7.Patients in whom the laparoscopic procedure will be converted to open cholecystectomy.
结局指标
主要结局
VAS score of shoulder pain at 4 hr, 8 hr, 24 hr, 7day. rescue analgesic used and dose
时间窗: VAS score of shoulder pain at 4 hr, 8 hr, 24 hr, 7day. rescue analgesic used and dose
次要结局
- surgeon satisfaction and ease of instrument manoeuvrability , operating time, any technical difficulty- requiring additional ports or increase in intra-abdominal pressure, gall bladder perforation, spillage of stone, requirement of saline lavage, drain placement(at induction, at start of aurgery, end of surgery)