A Comparative Study Of Fractionated Versus Bolus Dose Injection in Spinal Anesthesia For Patients Undergoing Elective Caesarean Section:a prospective,randomized controlled trial
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
- Duration of postoperative analgesia
研究概览
简要总结
This study is a randomized,double blind,parallel group controlled trial comparing the injection of fractionated dose versus bolus dose of 0.5% hyperbaric bupivacaine given for spinal anaesthesia in patients undergoing elective caeserean section to be conducted at Sri Lakshmi Narayana Institute of Medical Sciences,Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group.The secondary outcome measures will be duration of sensory and motor block , the perioperative hemodynamic changes and the side effects observed if any till 6 hours postoperatively.
Fractionated dose provides superior analgesia than bolus dose.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnant patients,ASA grade I and II, height 140-180 centimeters,with normal range of Body Mass Index,scheduled for elective Caeserean section under spinal anaesthesia.
排除标准
- •Patient refusal,ASA grade III,IV Height < 140 cm and > 180 cm, weight < 50 kg or >100 kg, Patients with altered mental status,spine deformities or history of laminectomy, Patients with preexisting diseases or pregnancy induced hypertension,cardiovascular or cerebrovascular diseases or any contraindications to spinal anaesthesia.
结局指标
主要结局
Duration of postoperative analgesia
时间窗: postoperatively every 30 minutes for the first 2 hours after surgery , then each hourly for next 4 hours
次要结局
- characteristics of sensory block(6 hours postoperatively)
- characteristics of motor block(6 hours postoperatively)
- any significant side effects(6 hours postoperatively)
- perioperative hemodynamic changes(6 hours postoperatively)