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临床试验/NCT05694897
NCT05694897已完成不适用

Ultrasound Guided Erector Spinae Block Using a Combination of Bupivacaine and Dexmedetomidine Versus Bupivacaine and Magnesium Sulfate for Postoperative Analgesia in Lumbar Spine Surgery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年7月30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
52
试验地点
1
主要终点
Dose of postoperative nalbuphine

研究概览

简要总结

This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups. Group BM (Bupivacaine + magnesium sulfate) will receive bilateral erector spinae block using bupivacaine and magnesium sulfate after induction of general anesthesia, while group BD (Bupivacaine + dexmedetomidine) will receive bilateral erector spinae block using bupivacaine and dexmedetomidine after induction of general anesthesia. Hemodynamic changes will be monitored intraoperatively, and postoperative pain will be assessed using the visual analogue scale in order to assess the need for postoperative analgesia.

详细描述

This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups.

General anesthesia will be induced using propofol 1-2mg/kg, fentanyl 2ug/kg, and atracurium 0.5mg/kg.

Both groups will receive bilateral erector spinae block Group BM will receive bilateral erector spinae block .A technique that will be performed ultrasound guided to identify the transverse process of T10, and an 18G (gauge) needle will be introduced in plane deep to the erector spinae muscle after which a combination of 20ml bupivacaine 0.25% and 2.5 ml magnesium sulfate.

While group BD will receive the same block with the with 20ml bupivacaine 0.25% and dexmedetomidine 1ug/kg.

Hemodynamic changes will be monitored intraoperatively, for detection of any variations.

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
None

入排标准

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

入选标准

  • •ASA 1, and 2

排除标准

  • •Patient refusal
  • •Spine deformities
  • •Coagulopathies
  • •Infection at the site of surgery
  • •Body weight above 100kg
  • •Known allergy to used drugs
  • •Psychiatric illness

研究组 & 干预措施

Erector spinae block using a combination of bupivacaine and magnesium sulfate

Active Comparator

Ultrasound guided erector spinae block at the level of T10 using a combination of 20 ml bupivacaine 0.25% and 3.75ml magnesium sulfate for treatment of postoperative pain

干预措施: Erector spinae block using bupivacaine 0.25% and magnesium sulfate (Procedure)

Erector spinae block using a combination of bupivacaine and dexmedetomidine

Active Comparator

Ultrasound guided erector spinae block at the level of T10 using a combination of 20 ml bupivacaine 0.25% and 1ug/kg dexmedetomidine for treatment of postoperative pain

干预措施: Erector spinae block using bupivacaine and dememdetomidine (Procedure)

结局指标

主要结局

Dose of postoperative nalbuphine

时间窗: 12 hours

Total dose of postoperative nalbuphine will be measured depending on the visual analogue scale

Measurement of the duration of postoperative analgesia

时间窗: 12 hours

Postoperative analgesia duration will be assessed using the visual analogue scale which is from 0-10 were 0 means no pain and 10 is the worst pain

次要结局

  • Patient satisfaction(48 hours)

研究者

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

Sameh Refaat

Lecturer of anesthesia

Ain Shams University

研究点 (1)

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