Ketamine as an adjuvant to USG guided Erector Spinae Plane Block with Ropivacaine for Perioperative Analgesia in Lumbar Spinal Surgeries: A Dose-Finding Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time to request of rescue analgesic in first 36 hours and assessment of duration of analgesic using VAS score at 0 hour,2 hour ,4 hour ,8 hour ,12 hour ,24 hour ,36 hour
研究概览
简要总结
Post operative pain management in spine surgeries is one of the main concerns because of its potential physiological adverse effects. In the era of Enhanced recovery after surgery, regional anesthesia is an effective method . The effectiveness of Erector spinae block has been demonstrated in various surgeries .Ketamine is known to prolong the duration of analgesia in peripheral nerve block without increasing ketamine related adverse effects. Ketamine was used at different doses in various studies but the effects were not as expected. At higher doses perineurally ketamine failed to produce significant analgesia. Therefore the optimal dosage of ketamine is yet to be determined. We designed a double blinded dose finding study to compare the analgesic efficacy of ketamine at three different doses in Erector spinae block when used with ropivacaine in patients planned for lumbar spinal surgeries .
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
- •All lumbo sacral surgeries including instrumentation procedures duration upto 4 hours of ASA grade I and II with BMI less than 24.
排除标准
- •Patient refusal ASA grade III and IV in scoliosis correction surgeries with intraoperative neuromonitoring and revision spine surgery duration more than 4 hours Patient with hypersensitivity to any of drugs in use Patient with congestive heart failure, CAD, chronic kidney disease, hepatic disease, neuropsychiatic disorder, coagulation abnormalities and pulmonary disease.
结局指标
主要结局
Time to request of rescue analgesic in first 36 hours and assessment of duration of analgesic using VAS score at 0 hour,2 hour ,4 hour ,8 hour ,12 hour ,24 hour ,36 hour
时间窗: Time to request of rescue analgesic in first 36 hours and assessment of duration of analgesic using VAS score at 0 hour,2 hour ,4 hour ,8 hour ,12 hour ,24 hour ,36 hour
次要结局
- Total intraoperative & postoperative opioid consumption(36 hours)
- Intraoperative haemodynamic stability(10mins)
- Occurrence of post operative nausea & vomiting(Anytime in first 36 hr)
研究者
Dr TIYASA PAIN
Institute of Neurosciences Kolkata