Comparative study of intraperitoneal instillation of bupivacaine alone and bupivacaine with dexmedetomidine for postoperative analgesia following laparoscopic cholecystectomy
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Post operative pain relief using visual analogue scale(0-100mm)
研究概览
简要总结
The primary purpose of this study is to analyse post operative analgesic efficacy both in terms of duration and degree of analgesia along with haemodynamic safety, of bupivacaine alone or in combination with dexmedetomidine when given intraperitoneally at the end of surgery in patients undergoing laparoscopic cholecystectomy.After taking informed consent patients will be allocated into either of two study groups keeping in mind blinding and patient group allocation concealment as per my protocol.Patients will be given intaperitoneal bupivacaine alone or bupivacaine with dexmedetomidine at the end of surgery before removal of trocar as per group allocation of patient.All patients will be shifted to PACU where VAS score,time to first rescue analgesic,24 hours post operative total analgesic requirement,PR,MAP,SPO2,Ramsay sedation score and any complication if any will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period.All data will be analysed statistically.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients posted for elective laparoscopic cholecystectomy 2.ASA physical status I & II 3.BMI >18.5 & <30.
排除标准
- •1.Patients refusal 2.Patients not satisfying above inclusion criteria 3.Allergic to study drugs 4.Pregnant or breast-feeding patient 5.Patients with cardiac,respiratory,liver and renal diseases 6.Patients with baseline heart rate<55/min.
- •7.Patients with AV heart blocks 8.Laparoscopic cholecystectomy converted to open cholecystectomy 9.If any other surgery,combined with laparoscopic cholecystectomy in the same sitting like incisional hernia,umbilical hernia etc.
结局指标
主要结局
1.Post operative pain relief using visual analogue scale(0-100mm)
时间窗: All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period
2.Time to first rescue analgesic
时间窗: All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period
3.24 hours post operative total analgesic requirement
时间窗: All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period
次要结局
- 1.Haemodynamic variables(PR,MAP,SPO2)(2.Ramsay sedation score)