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临床试验/NCT04433624
NCT04433624Unknown不适用

Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
time to first request of analgesics in hours

研究概览

简要总结

Introduction:

Severe postoperative pain following spine surgery is a significant cause of morbidity, extended length of facility stay, and marked opioid usage

The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids. The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression, constipation, delayed patient mobilization) has led perioperative physicians to find a way of decreasing the use of opioids. Increasing the use of regional anesthesia is one of the measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular, interfascial regional technique that was initially described for the management of thoracic neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, local anesthetic agents extend through several levels, and the block can be effective over a large area The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is suggested that magnesium has many important roles to play in nociception

详细描述

The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery

Inclusion criteria:

orthopedic and neurological patients undergoing posterior lumbar spine fusion [American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

  1. -Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
  2. allergic reaction to drugs.
  3. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
  4. opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • orthopedic
  • neurological patients
  • undergoing posterior lumbar spine fusion
  • American Society of Anesthesiologists (ASA) physical status 1 or 2.

排除标准

  • Contraindications for regional blocks
  • allergic reaction to drugs.
  • Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
  • opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).

结局指标

主要结局

time to first request of analgesics in hours

时间窗: change from base line for 24 hours

time to first request of analgesics by the pateint in hours

次要结局

未报告次要终点

研究者

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

doaa rashwan

Assistant professor Doaa Rashwan

Beni-Suef University

研究点 (1)

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