post operative analgesic effect of infiltration of bupivacaine and dexmedetomidine in surgical wound- A randomised placebo controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pain score by visual analogue score
研究概览
简要总结
A total of ninety patients will be enrolled, those aged between 15 - 60 years; of ASA status 1 and 2 and undergoing elective abdominal surgeries. They will be randomised into three groups; receiving placebo, bupivacaine (25 ml of 0.25%) and dexmedetomidine (1 mcg/kg dexmedetomidine added to 25 ml of 0.25% bupivacaine) at the end of surgery. pain at rest and on cough will be assessed up to 24 hours after surgery. rescue analgesia will be given with i.v. tramadol 1.5 mg/kg. number of patients requiring rescue analgesia and total consumption of tramadol will be recorded. level of sedation will be assessed using 4 point sedation scale. any adverse effects like nausea/vomiting, hypotension, bradycardia, dry mouth, dizziness, diplopia will be recorded.
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
- 15.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- ••Age 15 to 60 years.
- ••ASA grade I &II •Elective open abdominal surgeries, namely open cholecystectomy, nephrectomy, pyeloplasty.
排除标准
- ••Cardiopulmonary diseases •Hepato-renal insufficiency •Patients receiving adrenoceptor agonists, antagonists, narcotics, or NSAIDS prior to surgery.
- ••Raynauds disease •Morbid obesity.
结局指标
主要结局
pain score by visual analogue score
时间窗: 24 hours
次要结局
- sedation level(24 hours)
