跳至主要内容
临床试验/NCT05214157
NCT05214157已完成不适用

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

Zagazig University1 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2020年3月20日最近更新:
适应症
干预措施

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

Experimental

interventional group, final two operative steps applied

干预措施: active gas aspiration (Procedure)

group B

No Intervention

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed lotfy

Associate professor

Zagazig University

研究点 (1)

Loading locations...

相似试验