A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- postoperative pain intensity
研究概览
简要总结
evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.
详细描述
Introduction
After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were having symptoms consistent with biliary colic,
- •had ultrasound evidence of gall stones,
- •classified as American Society of Anesthesiology (ASA) I and II
- •ages ranging from 18 to 65 years
排除标准
- •Patients who refused to give consent,
- •pregnant,
- •had a history of drug abuse,
- •had CBD stones,
- •acute cholecystitis,
- •acute pancreatitis,
- •previous abdominal surgery,
- •history of peritonitis,
- •had carcinoma of the gall bladder Patients who were converted to open surgery,
- •patients who required placement of drains
- •patients with intraoperative complications (CBD injury or liver bed bleeding).
研究组 & 干预措施
group A
interventional group, final two operative steps applied
干预措施: active gas aspiration (Procedure)
group B
control group
结局指标
主要结局
postoperative pain intensity
时间窗: 6 - 24 hours
severity by visual analogue scale
次要结局
- hospital stay(1-5 days)
研究者
Mohamed lotfy
Associate professor
Zagazig University
