Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- post-operative fentanyl consumption
研究概览
简要总结
This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.
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)
盲法说明
It is double-blinded study. it is blinded to the participants and medical staff who record medical data for the patients.
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 to 10-year-old
- •ASA I, II, and II
排除标准
- •Patients whose parents or legal guardians refusing to participate.
- •Preoperative mechanical ventilation.
- •Preoperative inotropic drug infusion.
- •Known or suspected coagulopathy.
研究组 & 干预措施
Serratus Anterior Plan block
The SAPB was performed in the operative room (OR) after anesthesia induction using the same ultrasound machine (SonoSite) and linear ultrasound transducer 8- 12 Hz. The patient was positioned in a lateral position with the operative side up and arm flexed forward; then, a linear ultrasound transducer was placed in a sagittal plane over the mid-clavicular line of the thoracic cage. Then, moving inferior-lateral direction till the fifth rib was identified in the mid-axillary line. The following structures were recognized: the rib, pleura, teres major muscle (superior), latissimus dorsi muscle (superficial and posterior), and serratus muscles muscle (deep and inferior). Under complete sterile conditions, a 22-gauge echogenic needle was introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle. Then, 0.4 ml/kg of 0.25% bupivacaine was injected with continuous ultrasound guidance.
干预措施: Fascial plane block (Procedure)
Erector spinae plane block
Patients in Group ESPB receive US erector spinae plane block by injecting 0.4ml/kg (bupivacaine 0.25%). Under strict aseptic precautions, The T3 spinous process is located by palpating and counting down from the C7 spinous process. A high-frequency 12 MHz linear ultrasound transducer is placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Using an in-plane approach a 22 G needle is inserted in caudal-cephalad direction until the tip is deep to erector spinae muscle. Correct needle tip location is confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, bupivacaine is injected, and visualizing the fascial plane.
干预措施: Fascial plane block (Procedure)
结局指标
主要结局
post-operative fentanyl consumption
时间窗: 9 month
amount of fentanyl in mic consumed in the 24 hours postoperatively
次要结局
- RASS score(24 hours)
- patient satisfaction(24 hours)
- intraoperative fentanyl consumption(24 hours)
- time of first rescue analgesi(24 hours)
- Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.(24 hours)
- FLACC score at 1,2,4,8,12,24 hours postoperatively(24 hours)
- PONV(24 hours)
研究者
Ahmed Abdelaziz Ismail
Principle investigator
Cairo University