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临床试验/NCT03863977
NCT03863977已完成2 期

Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
1
主要终点
time of the first analgesic request

研究概览

简要总结

To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

详细描述

The transverses abdominis plane block (TAP block) is a regional anesthesia technique that provides analgesia following abdominal surgery . The TAP block significantly reduces pain after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia technique or as a complement to general anesthesia, spinal or local anesthesia .

The investigators designed this study to compare the postoperative analgesic effect of two doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

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

A blinded physician prepared the study medications in color coded syringes.

入排标准

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

入选标准

  • Patients' age from 18 to 60 years old,
  • physical status ASA I-II (by the American Society of Anesthesiologists),
  • Elective unilateral open inguinal hernia repair,
  • Under spinal anesthesia

排除标准

  • age < 18 or > 60,
  • American society of anesthesiologist (ASA)class III-IV,
  • known allergy to amino amide local anesthetics,
  • skin infection and diseases at site of injection.
  • coagulation disorders,
  • patients with body mass index (BMI) > 35 kg/m2,
  • scrotal hernias,

研究组 & 干预措施

Dex4 group

Active Comparator

After the surgery, the patients in this group will receive 4 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

干预措施: Dexamethasone (Drug)

Dex4 group

Active Comparator

After the surgery, the patients in this group will receive 4 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

干预措施: Bupivacaine (Drug)

Dex8 group

Active Comparator

After the surgery, the patients in this group will receive 8 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

干预措施: Dexamethasone (Drug)

Dex8 group

Active Comparator

After the surgery, the patients in this group will receive 8 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.

干预措施: Bupivacaine (Drug)

control group

Active Comparator

After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

time of the first analgesic request

时间窗: in the first postoperative 24 hours

time of the first analgesic request in the first postoperative 24 hours ,patients will receive analgesia if visual analog scale (VAS) score more than 3

次要结局

  • change in visual analog scale (VAS)(2nd, 4th, 8th, 16th, and 24th postoperative hours.)

研究者

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

Amani Hassan Abdel-Wahab

Principal Investigator

Assiut University

研究点 (1)

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