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临床试验/NCT05323565
NCT05323565Unknown4 期

A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients Undergoing Lower Open Abdominal Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
45
试验地点
1
主要终点
1st time for rescue analgesia

研究概览

简要总结

Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.

详细描述

A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.

排除标准

  • Infection at site of injection.
  • Patient refusal.
  • Psychiatric or physical illness that lead to inability to cooperate, speak or read.
  • Abdominal operations under spinal anesthesia.
  • History or evidence of coagulopathy.
  • Known allergies to drugs used .
  • Preexisting neurological disorders.

研究组 & 干预措施

Group A (n=15): (Dexamethasone group)

Active Comparator

Patients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock.

干预措施: Dexmedetomidine (Drug)

Group B (n=15): (Dexmedetomidine group)

Active Comparator

Patients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block.

干预措施: Dexmedetomidine (Drug)

Group C (n=15): (control group)

Sham Comparator

Patients will receive 20 ml 0.25% bupivacaine on each side TAB block.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

1st time for rescue analgesia

时间窗: first 24 hours post-operatively

Time to first analgesia requirment(starting from drug injection)

次要结局

  • Pain score- Visual Analogue Score (VAS)(First 24 hours post-operatively.)

研究者

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

Yasser Sayed Sobhy

Anesthesia specialist

Ain Shams University

研究点 (1)

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