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临床试验/CTRI/2024/03/064519
CTRI/2024/03/064519尚未招募4 期

The Analgesic Efficacy of Dexamethasone as an adjuvant to Levobupivacaine for Ultrasound Guided Bilateral Erector Spinae Plane Block in Thoraco-lumbar spine surgeries : A Randomized Study

Dr Vaishali Waindeskar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Visual Analogue Score (VAS) at 1, 2, 6, 12, 24 and 48 hours at rest (supine position) and during activity (defined as changing position from supine to sitting).

研究概览

简要总结

Patients undergoing thoracolumbar spine surgeries usually suffer severe pain during the perioperative period. Fascial plane blocks are emerging techniques in the management of pain both during the perioperative period and in the chronic pain. One among them is the Erector Spinae Plane Block (ESPB).Dexamethasone is added as an adjuvant to levobupivacaine in this study because it has been reported to prolong duration of action of local anesthetics with no respiratory depression or any adverse side effects. The aim of this study is to evaluate the efficacy of combining Dexamethasone to 0.25% Levobupivacaine in ultrasound guided bilateral Erector Spinae Plane Block in Thoraco-lumbar spine surgeries. Written informed consent will be taken and thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria . A standard general anesthesia technique will be followed in all patients. After turning to prone position, ESPB will be performed under ultrasound guided technique under strict aseptic precautions. After 15 -20 minutes of block setup time, the surgeons will be allowed to proceed with the surgical procedure and the block success will be assessed with the primary and secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
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 I-II, scheduled for single/double level thoracolumbar spine surgeries.

排除标准

  • Minimally invasive surgeries Patient’s refusal to the block procedure Contradictions to regional technique e.g., allergy to local anesthetic drugs, block site infection, coagulation disorders.
  • greater Body mass index of more than thirty five kilogram per meter square Pregnancy Physical or mental disorders that would interfere with the evaluation of pain.

结局指标

主要结局

Visual Analogue Score (VAS) at 1, 2, 6, 12, 24 and 48 hours at rest (supine position) and during activity (defined as changing position from supine to sitting).

时间窗: Visual Analogue Score (VAS) at 1, 2, 6, 12, 24 and 48 hours at rest (supine position) and during activity (defined as changing position from supine to sitting).

次要结局

  • Total postoperative diclofenac consumption till 48 hours.(Total opioid consumption.)

研究者

发起方
Dr Vaishali Waindeskar
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sutrishna Nag

All India Institute Of Medical Sciences, Bhopal

研究点 (1)

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