Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Time to first postoperative rescue analgesia
研究概览
简要总结
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •American society of anesthesiologists (ASA) class I and II
- •Children undergoing unilateral open renal surgeries
排除标准
- •Parents refusal for the block
- •Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- •Skin lesion, wounds or infection at the puncture site.
- •Known allergy to local anesthetic drugs
研究组 & 干预措施
Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Ultrasound-guided Erector Spinae Plane Block (Procedure)
Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Ultrasound Machine (Device)
Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Echogenic needle (Device)
Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Fentanyl (Drug)
Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Pethidine (Drug)
Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Ultrasound-guided Quadratus Lumborum Block (Procedure)
Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Ultrasound Machine (Device)
Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Echogenic needle (Device)
Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Fentanyl (Drug)
Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
干预措施: Pethidine (Drug)
结局指标
主要结局
Time to first postoperative rescue analgesia
时间窗: 12 hours
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
次要结局
- Intraoperative heart rate(During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block))
- Total opioid analgesic consumption in the first 12 hours postoperative period(from time of patient transfer to the PACU, till 12 hours postoperatively)
- Intraoperative mean arterial blood pressure(During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block))
- Postoperative pain score(from time of patient transfer to the PACU, till 12 hours postoperatively)
- Block performance time(Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.)
研究者
Kareem Mohammed Assem Nawwar
Lecturer
Cairo University