Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The time for first rescue analgesia after the TAP block
研究概览
简要总结
Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.
- Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
- Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
- Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.
详细描述
Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •parturients scheduled to undergo cesarean section under spinal anesthesia
排除标准
- •Patients who refused spinal anesthesia
- •women with chronic pelvic pain or on chronic morphine use
- •history of drug allergy
- •coagulation disorder
研究组 & 干预措施
bupivacaine 0.25% and Dexmedetomidine
bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
干预措施: bupivacaine (Drug)
bupivacaine 0.25% and Dexmedetomidine
bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
干预措施: Dexmedetomidine (Drug)
bupivacaine and clonidine
20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
干预措施: bupivacaine (Drug)
bupivacaine and clonidine
20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
干预措施: clonidine (Drug)
bupivacaine and placebo
bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
干预措施: bupivacaine (Drug)
bupivacaine and placebo
bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
干预措施: placebo (Drug)
结局指标
主要结局
The time for first rescue analgesia after the TAP block
时间窗: 24 hours post operative
calculation the time needed for first rescue analgesia after the TAP block
次要结局
- Total dose of rescue analgesia(24 hours postoperative)
- Adverse effects(24 hours postoperative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital