Comparison of Efficacy of Dexamethasone vs Dexmedetomidine Vs Ketamine as Adjuvants to Ropivacaine 0.375% for Bilateral Ultrasound guided Erector Spinae Block for Spinal Instrumentation Surgery- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Assessment of duration of analgesia using VAS pain score
研究概览
简要总结
Pain is main concern for all patients undergoing surgery. Drugs like benzodiazepines (like Midazolam, Diazepam) and opioids (like Fentanyl) have been used with their known side effects. Enhanced Recovery After Anaesthesia (ERAS) emphasizes the use of regional anaesthesia for postoperative analgesia with the goal of it being opioid free. Erector spinae plane block (ESPB) is a novel regional anaesthesia technique, which is a useful intervention in thoracic neuropathic pain and acute pain after surgery. The placement of local anaesthetics only in the interfacial plane for the block has been well established since its inception of use in pain management. However, to further the duration of analgesia additives are being deposited perineural along with local anesthetics. Perineurally deposited dexmedetomidine, dexamethasone and ketamine has been historically in use for peripheral nerve blocks, which is now finding its place in truncal blocks. Thus, this study is being conducted to compare the efficacy of dexmedetomidine, dexamethasone and ketamine along with 0.375 % ropivacaine in erector spinae plane block to reduce postoperative pain in dorsolumbar spine surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Aged 18–65 years ASA grade I, II Either gender BMI < 24 kg/m2 Surgical procedure: spinal instrumentation surgeries involving the dorso-lumbar spine (D10-S1) Duration of surgery: up to 4 hours.
排除标准
- •Patient refusal ASA Grade III/ IV Surgeries: Scoliosis correction surgery Spinal instrumentation surgery planned under intraoperative neuro-monitoring Revision spine surgery Duration of surgery >4 hours, Patients with hypersensitivity to any of the drugs in use History of congestive heart failure/ valvular heart disease/ IHD/Â cardiac conduction block/ renal dysfunction/ hepatic disease/ pulmonary disease/ neuropsychiatric disorders/ coagulation abnormality Puncture site infection History of chronic pain or central neuropathy.
结局指标
主要结局
Assessment of duration of analgesia using VAS pain score
时间窗: 0 hr | 2 hr | 4 hr | 8 hr | 12 hr | 24 hr
次要结局
- Total intraoperative and postoperative opioid consumption(24 hr)
- Intraoperative haemodynamic stability(10 min)
- First request of rescue analgesic(Anytime in first 24 hr)
- Occurrence of PONV in postoperative period(Anytime in first 24 hr)