跳至主要内容
临床试验/CTRI/2024/05/067061
CTRI/2024/05/067061
尚未招募
不适用

A Prospective, Randomised, Double blind study comparing postoperative analgesia using 0.25% Bupivacaine vs 0.375% Bupivacaine along with 8mg Dexamethasone in USG guided Erector Spinae Plane Block in thoracolumbar spine surgeries.

SETH GS MEDICAL COLLEGE AND KEM HOSPITAL1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月17日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL
入组人数
40
试验地点
1
主要终点
Evaluation of total duration of post operative Analgesia.

概览

简要总结

Postoperative analgesia in patients undergoing thoraco lumbar spine surgery is challenging due to the invasiveness of the surgical procedure and the frequent use of opioids perioperatively by many patients. The Study Aims to compare the duration of postoperative analgesia in USG guided erector spinae plane block in thoracolumbar spine surgeries using 0.25% bupivacaine and 8mg Dexamethasone vs 0.375% bupivacaine and 8mg dexamethasone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I–II -Planned posterior approach spinal surgery involving 2-3 levels of laminectomy in the lumbar or thoracic regions.
  • Surgery with a maximum duration of 3 hours.

排除标准

  • Pregnant females -Uncooperative patients with communication difficulties which might prevent a reliable post operative assessment.
  • Relative contraindication like Pre-existing infection at block site, coagulopathy, allergy to local anaesthetics.
  • Surgery involving 4 or more vertebral levels -Revision surgeries.

结局指标

主要结局

Evaluation of total duration of post operative Analgesia.

时间窗: AT 2,4,6,10,14,18,24 HOURS.

次要结局

  • To note 1)Intraoperative hemodynamics. 2) Total consumption of rescue analgesia within 24hours 3) Complications like nausea vomiting, hypotension, hypertension, bradycardia, tachycardia.(24 HOURS)

研究者

发起方
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shrikanta Oak

Seth G S Medical college and KEM Hospital, Mumbai

研究点 (1)

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