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临床试验/CTRI/2023/07/054840
CTRI/2023/07/054840尚未招募2/3 期

Comparison of perineural & intravenous magnesium sulphate as an adjuvant to levobupivacaine in ultrasound – guided supraclavicular brachial plexus block: A prospective randomized trial

Chettinad Academy of Research and Education1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年7月14日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
To compare the onset of sensory & motor block

研究概览

简要总结

To compare analgesic efficacy between perineural and intravenous magnesium sulphate as an adjuvant to levobupivacaine in ultrasound-guided supraclavicular brachial plexus block

Group 1 perineural magnesium sulphate – patient will receive 0.5% levobupivacaine (24.5ml) with 250 mg of magnesium sulphate (0.5ml) total volume of 25ml in usg guided supraclavicular nerve block

Group 2 intravenous magnesium sulphate – patient will receive 0.5% levobupivacaine  (24.5ml) with 0.5ml NS total volume of 25ml in usg guided supraclavicular nerve block plus 30 mg/kg iv magnesium sulphate

Primary objective

•To compare the onset of sensory and motor block

Secondary objective

•To compare the duration of analgesia

•To compare the requirement of rescue analgesic in the postoperative period

•To compare the side effects (if any)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age between
  • 60 years 2.Both sexes
  • ASA Classes I,II and III patients
  • Patients posted for upper limb surgery below shoulder.

排除标准

  • 1.Patient refusal
  • Coagulopathy
  • History of allergy to local anesthetics
  • Infection at the site of block
  • Neurodeficit involving brachial plexus
  • Pregnant women
  • Patients with psychiatric behavior
  • ASA Class IV patients 9.Obese patients BMI>35kg/m2.

结局指标

主要结局

To compare the onset of sensory & motor block

时间窗: One year

次要结局

  • •To compare the duration of analgesia •To compare the requirement of rescue analgesic in the postoperative period • To compare the side effects (if any)(One year)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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