Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
2022年5月19日 更新者：Kareem Mohammed Assem Nawwar、Cairo University
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (预期的)
60
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kareem MA Nawwar, M.D.
- 电话号码：+201003878369
- 邮箱：drknawwar@cu.edu.eg
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 至 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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%
|
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique.
The spread of the injectate will be observed to distribute within this plane.
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
|
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有源比较器：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%
|
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it.
The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique.
The spread of the injectate will be observed to distribute within the target plane.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first postoperative rescue analgesia
大体时间：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).
|
12 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total opioid analgesic consumption in the first 12 hours postoperative period
大体时间：from time of patient transfer to the PACU, till 12 hours postoperatively
|
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively.
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).
|
from time of patient transfer to the PACU, till 12 hours postoperatively
|
|
Intraoperative mean arterial blood pressure
大体时间：During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
|
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
|
Intraoperative heart rate
大体时间：During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
|
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
|
Postoperative pain score
大体时间：from time of patient transfer to the PACU, till 12 hours postoperatively
|
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
|
from time of patient transfer to the PACU, till 12 hours postoperatively
|
|
Block performance time
大体时间：Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
|
Time to perform ultrasound guided nerve block
|
Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Indirect signs of local anesthetic toxicity
大体时间：from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
|
intraoperative arrhythmias and delayed awakening
|
from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Nevine M Gouda、Cairo University
- 学习椅：Sherif M Soaida、Cairo University
- 学习椅：Ismail S Hammad、Cairo University
- 首席研究员：Ahmed T Bahnaswy、Cairo University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年5月20日
初级完成 (预期的)
2022年9月1日
研究完成 (预期的)
2022年9月15日
研究注册日期
首次提交
2022年5月8日
首先提交符合 QC 标准的
2022年5月19日
首次发布 (实际的)
2022年5月23日
研究记录更新
最后更新发布 (实际的)
2022年5月23日
上次提交的符合 QC 标准的更新
2022年5月19日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.