Post-operative pain relief in laparoscopic cholecystectomy, comparison between Opioid-free anaesthesia using injection Dexmedetomidine infusion and injection Lidocaine bolus vs Opioid anaesthesia using injection Fentanyl: A Randomized Controlled Prospective, Double Blind Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare pain relief in post operative period using visual analogue scale for 24 hour during rest at 0, 2, 4, 6, 12, 24 hours & at movement (coughing & lateral decubitus position )at 6, 12, 24 hours
研究概览
简要总结
The aim of this study to compare pain relief between opioid free analgesia group and opioid group posted for laparoscopic cholecystectomy for gall stone . subjects and outcome assessor are blinded to type of group ,patients age between 18 to 70 years with cholelithiasis scheduled for surgery will be assessed for eligibility to participate in study . patients with ASA > III allergy to drugs used in trial are excluded .during surgery intraoperative parameters (HR, BP ) between 2 groups noted before induction and at 5, 15, 30, 60 min after induction for all patients subjects will receive either opioid analgesia or opioid free analgesia after randomization .monitor throughout surgery .
after surgery patients will be monitored in PACU for pain relief using Visual analogue scale at 2,4,6,12,24 hr at rest and 6,12,24 hr at movements . inadeqate pain relief VAS more than 4 non opioid based analgesia inj diclofenac sodium 75 mg and VAS more than 8 opioid based analgesia inj Tramadol 50 mg will be administered . for 24 hr post operative period pain will be assessed .and post operative nausea vomiting will be noted treated with antiemetic .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •All patients coming for laparoscopic cholecystectomy surgery of American Society of Anesthesiologists Grade I-II patients.
排除标准
- •1.BMI: 35 and above 2.Second degree Heart block and above 3.Bradycardia and hypotension 4.Diabetes 5.Psychiatric disease 6.History of chronic pain 7.Alcohol or drug abuse 8.Allergy to any of a drug in the study groups 9.Pregnant, breast-feeding or menstruating women 10.Any analgesic or antiemetic use in last 24 hours before anaesthesia induction.
结局指标
主要结局
To compare pain relief in post operative period using visual analogue scale for 24 hour during rest at 0, 2, 4, 6, 12, 24 hours & at movement (coughing & lateral decubitus position )at 6, 12, 24 hours
时间窗: 24 hours post operative period
次要结局
- 1. Comparison of intra-operative hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure) between 2 groups at just before induction & at 5, 15, 30, 60 min after induction for all patients.(2. Compare total rescue analgesic requirements between 2 groups in first 24 hours.( rescue non-opioid analgesic Inj. Diclofenac 75mg will be given If VAS more than 4, those patients with persistent severe pain [VAS more than 8-10],opioid analgesia in form of Inj. Tramadol 50 mg.))