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
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
- 否
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
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
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
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
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
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
Amani Hassan Abdel-Wahab
Principal Investigator
Assiut University