A Randomized study to Compare Analgesic Efficacy of Ropivacaine with Dexmedetomidine Versus Ropivacaine with Magnesium fulfate in Surgical Site Infiltration in Patients Undergoing Lumbar Spine Fixation Surgery under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To asses and compare mean NRS score at different intervals between the study groups
研究概览
简要总结
This study aims to compare the analgesic efficacy of two combinations of medications used for surgical site infiltration in patients undergoing lumbar fixation surgery. Specifically, it will evaluate Ropivacaine combined with Dexmedetomidine versus Ropivacaine combined with Magnesium sulfate. The study will measure postoperative pain relief using Numerical Rating scale (NRS) scores at various time points, the time to first analgesic request, and total analgesic consumption. Additionally, it will monitor side effects such as hypotension, bradycardia, and nausea. This prospective, randomized, double-blind trial will provide insights into which combination offers superior pain control, potentially improving post-surgical recovery and reducing the need for opioids.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written and informed consent Patients undergoing lumbar spine fixation surgery Patients with ASA physical status 1 or 2.
排除标准
- •Non cooperative patients BMI more than 35kg/m2 History of allergy to any other drugs used during the study.
结局指标
主要结局
To asses and compare mean NRS score at different intervals between the study groups
时间窗: Just after extubation ,2hours ,6hours ,12hours, 24hours
To assess and compare in mean time of first rescue analgesia intravenous Diclofenac between the study groups
时间窗: Just after extubation ,2hours ,6hours ,12hours, 24hours
To asses and compare the difference in mean total number of doses of intravenous Diclofenac in 24 hours postoperatively between the study groups
时间窗: Just after extubation ,2hours ,6hours ,12hours, 24hours
次要结局
- To assess and compare post operative hemodynamic vitals between the study groups(To determine the proportion of patients experiencing side effects between study groups)