Comparison of local infiltration of ropivacaine plus dexmedetomidine versus ropivacaine plus magnesium sulfate for postoperative analgesia in patients undergoing lumbar spine surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the post operative analgesic effect using VAS score between group RD ( ropivacaine+ dexmedetomidine) and group RM( ropivacaine + MgSO4)
研究概览
简要总结
In lumbar spine surgeries patients usually complain of severe pain during the initial 12 hours of postoperative period. This causes delayed mobilization and contributes to increased risk of medical complications such as pneumonia, deep vein thrombosis, urinary tract infections and psychological stress.
Wound infiltration with local anaesthetic is an effective strategy. But the pain relief is present only till effects of local anaesthetic action persists.
Hence various adjuvants such as dexmedetomidine, magnesium, clonidine are added to lengthen the duration of action of local anaesthetic.
Dexmedetomidine an alpha -2 adrenoceptor agonist extend the duration of local anaesthetic for pain relief. Magnesium sulfate is a physiological antagonist at NMDA receptor used to enhance the effect of analgesia.
However there are not many clinical studies available to compare the efficacy of magnesium sulfate combined with local anaesthetic drugs for wound site infiltration in lumbar spine surgeries.
Thus we hypothesize that local infiltration of surgical site with ropivacaine and dexmedetomidine likely to provide better post operative analgesia effect in comparison to ropivacaine plus magnesium sulfate as assessed by visual analogue scale (VAS) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •American Society of Anesthesiologists Physical status 1,2 scheduled for elective single/double level spine surgeries such as discectomy, laminectomy, posterior instrumentation under general anaesthesia.
排除标准
- •Patient with severe medical conditions like 1.BMI ≥ 30kg/m2 2.Inadequately controlled hypertension or diabetes mellitus 3.Asthma or COPD 4.Ischemic heart disease or other cardiac disorders 5.Kidney or liver diseases 6.Pre-existing cognitive impairment Neurological deficits or psychiatric disorders 7.Chronic use of antipsychotic medications or substance use disorders 8.Pregnancy 9.Patients allergic to ropivacaine, dexmedetomidine or magnesium sulfate.
结局指标
主要结局
To compare the post operative analgesic effect using VAS score between group RD ( ropivacaine+ dexmedetomidine) and group RM( ropivacaine + MgSO4)
时间窗: at 0 minute, after shifting to post anaesthesia care unit (PACU), 30 minutes, 1st hour, 2nd hour, and thereafter at 4th hour, 6th hour, 12th hour, and 24th hour.
To compare the mean duration of time to first rescue analgesia between group RD and RM
时间窗: at 0 minute, after shifting to post anaesthesia care unit (PACU), 30 minutes, 1st hour, 2nd hour, and thereafter at 4th hour, 6th hour, 12th hour, and 24th hour.
次要结局
- To evaluate total analgesic consumption between the study groups.(To compare the post operative analgesic effect using VAS score between the gender.)
研究者
Yashashwini B
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL