Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.
详细描述
A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.
After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.
After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .
Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.
The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA I-II physical status patients.
- •Genders Eligible for Study :male.
- •All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
- •Duration of Laparoscopic procedure not exceeding 90 minutes.
- •Written informed consent from parent of guardian .
排除标准
- •Sensitivities to local anesthetics.
- •Significant renal, liver, or cardiac disease.
- •Surgery requiring an open procedure
研究组 & 干预措施
Group B
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
干预措施: Bupivacaine 0.125% (Drug)
Group C
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
pain score
时间窗: 12 hours postoperative
Children's Hospital Eastern Ontario Pain Scale
次要结局
- Total intraoperative fentanyl consumption(12 hours postoperative)
- number of participants with incidence of infection(12 hours postoperative)
- Total postoperative paracetamol consumption(12 hours postoperative)
- Number of participants with incidence of vomiting(12 hours postoperative)
- number of participants with incidence of nausea(12 hours postoperative)
- number of participants with incidence of hematoma(12 hours postoperative)
研究者
Abdelrady S Ibrahim, MD
Assistant professor of Anesthesia and Intensive care
Assiut University