Comparison of bolus dose versus fractionated dose of hyperbaric bupivacaine and fentanyl in spinal anaesthesia among adult patients undergoing lower limb surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
研究概览
简要总结
Spinalanesthesia plays a critical role in lower limb surgeries, offering effectiveanalgesia and muscle relaxation. The choice between fractionated dose and bolusdose administration of bupivacaine remains a topic of debate amonganesthesiologists, with implications for patient outcomes and surgical success.This thesis aims to provide a comprehensive comparative analysis offractionated dose versus bolus dose administration of bupivacaine in spinalanesthesia for lower limb surgery, focusing on efficacy, safety, andpatient-centered outcomes.
Aims andObjectives:
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To comparethe effects on haemodynamic parameters between Bolus dose versus Fractionateddose of intrathecal bupivacaine and fentanyl.
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To comparethe block characteristics and post operative analgesia in patients receiving Bolusdose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
Materials andMethods:
This will be a randomized double blind study to bedone on 90 patients of 18-60 years of age admitted at Christian Medical Collegeand Hospital Ludhiana scheduled for elective lower limb surgery under spinalanaesthesia. They will be divided into two groups using block randomisationmethod (Group A-Bolus dose and Group B- Fractionated dose). The parameters likesensory blockade, motor blockade and hemodynamic profile along with duration ofanalgesia will be evaluated.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient who give informed consent.
- •2.ASA (American Society of Anaesthesiologists) I & II[ANNEXURE1] 3.All men and women 4.Adult 18-60 years 5.Elective lower limb surgeries under spinal anaesthesia.
排除标准
- •1.Patients with significant neurological deficit.
- •2.Spinal column deformities.
- •3.Patients on anticoagulants.
- •4.Allergic to local anaesthetic.
- •5.Allergic to adjuvant drug.
- •6.Patient with any skin lesion at the injection site.
结局指标
主要结局
1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
时间窗: Hemodynamic Trends (HR, SBP, DBP, MAP, SpO2)-Baseline (before spinal anesthesia), then intraoperatively at 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, 110 min, and 120 min. | Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.
次要结局
- To compare block characteristics & post operative analgesia in patients receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine & fentanyl.(Sensory & Motor Block Characteristics-Every 5 minutes intraoperatively until maximum block is achieved, then postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.)