Dexmedetomidine as an Adjuvant to Bupivacaine in Unilateral Transversus Abdominis Plane Block in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Quality of analgesia
研究概览
简要总结
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery.
详细描述
After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment.
General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 s as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block will be performed in All patients immediately after induction patients will be allocated randomly into three equal groups, 30 patients in each as the following.
Group 1 (control group) TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) Group 2 We will carry out TAP block using the same dose of bupivacaine in the control group plus dexmedetomidine 0.5 μg / kg as an adjuvant Group (3) In this participants dexmedetomidine in dose 1 μg / kg will be given as an adjuvant to the control dose of bupivacaine in the TAP block TAP block procedure With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. (Al-Sadek et al.,2014).
The procedure will be performed immediately after induction of anesthesia by candidate anesthesiologist who is not aware of group allocation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I or II, aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall
排除标准
- •Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study
研究组 & 干预措施
Control group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%)
干预措施: Bupivacain (Drug)
Dexmedetomidine 0.5 μg group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 0.5 μg / kg as an adjuvant
干预措施: Dexmedetomidine o.5 μg (Drug)
Dexmedetomidine 1 μg group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 1 μg / kg as an adjuvant
干预措施: Dexmedetomidine 1 μg (Drug)
结局指标
主要结局
Quality of analgesia
时间窗: 24 hours after block
Quality of analgesia will be assessed by using FLACC scale (face,leg,activity,cry and consolability)
次要结局
- postoperative complication(For 24 hours after surgery)
- parents' satisfaction(24 hours)
研究者
haidy salah mansour
Professor
Minia University