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临床试验/NCT02858622
NCT02858622已完成不适用

Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study

Cairo University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
total dose of rescue analgesia

研究概览

简要总结

Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3-16 years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

排除标准

  • known allergy to bupivacaine

研究组 & 干预措施

dual TAB group

Active Comparator

22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg

干预措施: bupivacaine (Drug)

dual TAB group

Active Comparator

22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg

干预措施: Pethidine (Drug)

dual TAB group

Active Comparator

22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg

干预措施: perfalgan (Drug)

dual TAB group

Active Comparator

22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg

干预措施: fentanyl (Drug)

control group

Sham Comparator

22 patients who will not receive dual TAB block

干预措施: Pethidine (Drug)

control group

Sham Comparator

22 patients who will not receive dual TAB block

干预措施: perfalgan (Drug)

control group

Sham Comparator

22 patients who will not receive dual TAB block

干预措施: fentanyl (Drug)

结局指标

主要结局

total dose of rescue analgesia

时间窗: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

pethidine given as rescue analgesia postoperative.

次要结局

  • Intraoperative blood pressure(from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours)
  • pain scoring system (objective behavioural pain score)(from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative)
  • postoperative heart rate(from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours)
  • intraoperative heart rate(from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours)
  • postoperative blood pressure(from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherif Mohamed Abd el moneim Soaida, MD

Assistant Professor

Cairo University

研究点 (1)

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