CTRI/2021/09/036479尚未招募不适用
Comparison of analgesic effect of incision site infiltration versus scalp nerve block with 0.75% Ropivacaine in cases undergoing supratentorial craniotomy under general anaesthesia: A randomized Interventional study, S.M.S. Medical college, Jaipur during the year 2020-2021.
Department of Anaesthesiology SMS Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean time duration for the need of first rescue analgesia
研究概览
简要总结
The study is randomized interventional study comparing the analgesic effect of incision site infiltration versus scalp nerve block using 0.75% ropivacaine in patients undergoing supratentorial craniotomy aged between 20 to 55 years by measuring mean time duration for the need of first rescue analgesia, total dose of analgesia required in 24 hours and change in CRP levels in 60 patients as the primary outcome. As the secondary outcome hemodynamic changes during surgery and side effects after surgery will be measured. This will be conducted in department of anaesthesiology, neurosurgery OT, SMS Medical college and hospital, Jaipur
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
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade I-III patients willing to give written and informed consent, GCS above 13,Weight of Patients between 40 to 75kg.
排除标准
- •History of allergy to anaesthetic agents used in the study, History of uncontrolled hypertension, arrhythmia, coagulation disorder, Past History of craniotomy surgery, Pregnancy, Any absolute or relative contraindication to study drug, Non communicative status, Psychiatric patients, Surgery more than 5 hours.
结局指标
主要结局
Mean time duration for the need of first rescue analgesia
时间窗: After the end of surgery in post operative period
次要结局
- change in mean C-Reactive Protein levels(Baseline, 8hours after skin incision, 24hours after skin incision)
- Total dose of analgesia required(24 hours starting from skin incision)
- percentage of cases who develop side effects(After the end of surgery in postoperative period)
- change in intra-operative hemodynamic parameters(Baseline, Just after induction, Just after intubation, Just after scalp nerve block/ incision site infiltration, Skin incision, 5 minutes after skin incision, 10 minutes after skin incision, During skull drilling, During dura opening and after every 15 minutes till the end of the surgery)
研究者
研究点 (1)
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