Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy, a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Shoulder tip pain
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.
详细描述
We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 15 years
- •Elective procedure of laparoscopic cholecystectomy
- •Sign to Inform consent
排除标准
- •Emergency surgery
- •Concomitant other procedure performed
- •Deny to participant
结局指标
主要结局
Shoulder tip pain
时间窗: 48 hours
The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region.
次要结局
- Change of intra-abdominal pressure(Immediately after surgery)
- Difficulty of the operation(Immediately after surgery)
研究者
Narongsak Rungsakulkij
Assistant Professor
Mahidol University