Comparison of Analgesic Efficiency in Laparoscopic Percutaneous Extraperitoneal Closure for Pediatric Inguinal Hernia and Hydrocele Provided by Ultrasound Guided Posterior Quadratus Lumborum Block Using Between 0.125% and 0.25% Bupivacaine
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of postoperative analgesia
研究概览
简要总结
The aim of the present study is to evaluate and compare the analgesic efficiency of the difference concentration between 0.125% and 0.25% bupivacaine provided by ultrasound guided posterior quadratus lumborum block undergoing LPEC in children
详细描述
Fifty participants both male and female aged from 1 to 6 years old, AGED FROM 1 TO 6 YEARS OLD, ASA class I to II undergoing elective Laparoscopic percutaneous extraperitoneal closure for pediatric inguinal hernia and hydrocele will be randomly divided into two equal groups of twenty five by using computer generated random table.
All received premedication in the form of midazolam 0.1 mcg/kg IV. Perioperative monitoring included continuous ECG, NIBP and pulse oximetry. Baseline reading of these were recorded. General anesthesia will be inducted using thiopental 5 mg/kg then atracurium 0.5 mg/kg to facilitate endotracheal tube intubation and fentanyl 1 mcg/kg. Anesthesia will be maintained using 2% isoflurane with oxygen to air 40:60.
Posterior quadratus lumborum block (The technique which local anesthetic agent is injected at middle thoracolumbar fascia between erector spina muscle and quadratus lumborum muscle) provided by GE, LOGIQe VERSION (12L-RS, LINEAR ARRAY) ultrasound guided and using stimuplex needle 22G-2 inches on both sides under sterile technique in lateral position will be performed in all patients immediately after induction and before starting surgery. patients will be allocated randomly into two equal groups, twenty five in each as the following GROUP 1 will receive 0.25% bupivacaine 0.4 ml/kg. per each side. GROUP 2 will receive 0.125% bupivacaine 0.4 ml/kg. per each side. The patients and parents along with independent anesthesiologist and attending nurses were not aware of group allocation.
The surgical intervention was started not less than 10 minutes after block. Pneumoperitonium pressure was limited not exceed 10 mmHg. After completion of surgery, anesthesia was discontinued and muscle relaxant was reversed as usual. After extubation, the patients will be transfer to PACU.
Postoperative pain will be assessed by attending nurses, using CHEOPs SCORE. Acetaminophen 10 mg/kg. orally will be given as rescue analgesia for patient with CHEOPs SCORE more than 6. Parameters will be assessed
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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
- •ASA I-II physical status patients
- •Complete inform consent for intervention
排除标准
- •Contraindication for regional anesthesia
- •Sensitive to local anesthetic agent, opioid or acetaminophen
- •Previous history of abdominal surgery
- •History of neuromuscular disease
- •G6PD deficiency
研究组 & 干预措施
ROUTINE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.
干预措施: Bupivacaine hydrochloride (Drug)
ALTERNATIVE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.
干预措施: Bupivacaine hydrochloride (Drug)
结局指标
主要结局
Quality of postoperative analgesia
时间窗: 24 hours after surgery
Postoperative pain score as CHEOPs SCORE
次要结局
- Incidence of complications(12 hours after surgery)
研究者
Kullasate Sakpichaisakul
Queen Sirikit National Institute of Child Health
Queen Sirikit National Institute of Child Health