CTRI/2022/09/045813尚未招募2/3 期
A Comparative study on Dexamethasone as an adjuvant to 0.2% Ropivacaine in USG Guided Pre-Emptive Caudal Epidural block for perioperative analgesia in patients undergoing degenerative lumbar spine surgeries
Dr Sitara A Y1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月30日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare intraoperative opioid consumption
研究概览
简要总结
This study is a randomized, double blind, parallel group, trial comparing the safety and efficacy of Ropivacaine 0.2% and Ropivacaine 0.2% with Inj Dexamethasone 8mg in 50 patients undergoing lumbar spine surgery that will be conducted in Vydehi medical college and research centre in India. The primary outcome measures will be opioid consumption between the 2 groups and Duration and efficacy of analgesia between the group. The secondary outcomes will be hemodynamic changes in the peri operative period between the group and adverse effects like nausea, vomiting, dowsiness, sedation in post operative period between the two group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients belonging to ASA I,II.
- •Patients who give informed written consent.
排除标准
- •1.Patients refusal for study, patients who underwent a previous lumbar spine surgery
- •Patients with a contraindication to regional anaesthesia
- •Patients with hypersensitivity to ropivacaine.
- •Patients with known cardiac, renal, hepatic, neurological disorders that would interfere with cardiovascular response assessment.
- •Patients with spine abnormalities and body dysmorphism.
- •Patients with coagulopathy or on any anti coagulants.
- •Use of benzodiazepines, anticonvulsants, alcohol, opioids or other psychotropic drugs.
结局指标
主要结局
To compare intraoperative opioid consumption
时间窗: 6-48hrs
To compare duration of analgesia
时间窗: 6-48hrs
次要结局
- To compare the hemodynamic changes(To compare adverse effects)
研究者
研究点 (1)
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