跳至主要内容
临床试验/NCT06501079
NCT06501079招募中不适用

The Efficacy of Dexamethasone Versus Magnesium Sulphate Added to Bupivacaine Used in Erector Spinae Plane Block for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
1
主要终点
postoperative opioid consumption

研究概览

简要总结

Aim of the study:

The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain.

Primary Objectives:

- To compare the effect of ESPB without additives to the effect of adding dexamethasone and to the impact of adding magnesium sulfate in the form of post-operative morphine consumption

详细描述

Aim of the study:

The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain and postoperative morphine consumption.

Methodology:

I. Study design:

This is a randomized Controlled Study. It will involve three groups: Control Group (C) receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS, Group (M) receiving 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10%, Group (D) receiving 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

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

入选标准

  • Adult (18 - 65)
  • Patients undergoing unilateral nephrectomy
  • ASA II / III

排除标准

  • Patient refusal
  • Age less than 18 years
  • Allergy to any of the studied medications
  • Mid line incision
  • Bilateral nephrectomy
  • Distorted anatomy of the back (e.g. kyphoscoliosis)
  • Known neurologic disorders, psychiatric disorder or chronic pain
  • Local infection
  • Hemodynamic instability

结局指标

主要结局

postoperative opioid consumption

时间窗: 24 hours post-operatively

total postoperative rescue analgesia be by Morphine

次要结局

  • time of first rescue analgesia(during 1st 24 postoperatively.)
  • Intraoperative opioid consumption(intraoperative)
  • visual analogue scale 30 hours post-operatively at rest(24 hours post-operatively at rest)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Soliman

lecturer of anesthesia

National Cancer Institute, Egypt

研究点 (1)

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