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临床试验/NCT03956966
NCT03956966已完成不适用

Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy

Minia University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Time for first request to rescue analgesia

研究概览

简要总结

The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.

详细描述

The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.

The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Physical Status I or II
  • Elective laparoscopic Cholecystectomy

排除标准

  • Patient refusal.
  • Hematological diseases
  • Bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Emergency laparoscopic cholecystectomy
  • If laparoscopic procedure converted to open.

研究组 & 干预措施

saline

Placebo Comparator

bilateral quadratus lumborum block using 0.9% normal saline

干预措施: TQL block with saline (Drug)

Bupivacaine

Active Comparator

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%

干预措施: TQL block with Bupivacaine (Drug)

Bupivacaine and dexamethasone

Active Comparator

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone

干预措施: TQL block with Bupivacaine and dexamethasone (Drug)

结局指标

主要结局

Time for first request to rescue analgesia

时间窗: 24 hours

Time for the first request to rescue analgesia (in minutes)

次要结局

  • intraoperative fentanyl(For 4 hours after start of anaesthesia)
  • side effects(For 24 hours after surgery)
  • postoperative Nalbuphine(24 hours after surgery)
  • Postoperative pain severity will be assessed using VAPS(For 24 hours after surgery)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

haidy salah mansour

principle investigator

Minia University

研究点 (1)

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