Efficacy of dexamethasone versus ketamine as adjuvant to 0.25 percentage Levobupivacaine in Ultrasound-guided erector spinae plane block in lumbar fusion surgery- A randomized controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To compare the Visual Analog Scale(VAS) pain scores to 0,2,4,8,12,18 and 24 hours post operatively
研究概览
简要总结
The erector spinae plane (ESP) block is a safe and effective technique for postoperative analgesia in Lumbar Fusion Surgery. Dexamethasone, a glucocorticoid acting via C fiber inhibition, or Ketamine which is a NMDA receptor antagonist when added to Levobupivacaine can prolong its analgesic effect.
Primary objective: To assess postoperative pain scores over 24 hours in patients undergoing lumbar spine fusion surgery who receive either a combination of levobupivacaine and dexamethasone or ketamine.
Secondary Objective: Intraoperative hemodynamic changes , Time of requirement of first rescue analgesic ,total number of times of requirement of rescue analgesic. and its associated side effects.
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
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society Of Anaesthesiologists(ASA) physical status I-III.
- •2.Patients aged more then 30 years undergoing single level lumbar fusion surgery .
排除标准
- •1.Allergy to study drugs 2.Coagulopathy 3.Local and systemic infections.
- •4.Patients with cognitive impairment .
- •5.BMI more than or equal to 30 kg per m² 6.Lumbar spine injury.
- •7.Significant hepatic and renal function impairment.
结局指标
主要结局
To compare the Visual Analog Scale(VAS) pain scores to 0,2,4,8,12,18 and 24 hours post operatively
时间窗: 0,2,4,8,12,18 and 24 hours
次要结局
- 1.Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) before incision, 3mins after incision and then every 15 minutes till the end of surgery,(2.Time to first rescue analgesic.)
研究者
Dr Debasis Kuanar
Kalinga Institute Of Medical Sciences