A Randomized Controlled Trial comparing the analgesic effects of Sacral Erector Spinae Block and Caudal Block in Pediatric Genitourinary and Perineal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To compare the duration of analgesia between the two groups in the form of time to first rescue analgesia.
研究概览
简要总结
Pediatricperineal and genitourinary surgeries are extensive and painful requiringadequate analgesia in the perioperative period. Caudal block has remained thestandard and effective method of managing perioperative analgesia, however, ithas few serious risks associated. The newer Erector Spinae Block (ESPB) hasbeen established in adults as well as in pediatrics at various spinal levelsand has proven to have safer profile with no involvement of any adjacent vitalstructures. There is limited literature present comparing the sacral ESPB andcaudal block in pediatric surgeries.
The hypothesis of this study is that sacral ESPBcan provide comparable analgesic effects to caudal block in pediatric patientsundergoing genitourinary and perineal surgeries, as measured by the duration ofpostoperative analgesia, pain scores and the need for rescue analgesics withbetter safety margin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with American Anesthesiology Society (ASA) physical status I and II.
- •Patients posted for elective genitourinary- like uretheroplasty and perineal surgery- like anoplasty, vaginoplasty and posterior sagittal anorectoplasty (PSARP).
排除标准
- •Patients with significant renal, hepatic, bleeding disorder, skeletal muscles disorder or any other neurological deficit e.g. mental retardation.
- •Patients having known allergy to study drug.
- •Contraindication to regional block.
- •Day care surgeries like circumcision, stent removal etc.
结局指标
主要结局
To compare the duration of analgesia between the two groups in the form of time to first rescue analgesia.
时间窗: Pain (FLACC) scoring will be done at admission in PACU, then every 30 minutes till 2 hours then at 4, 8 and 24 hours. Time to first rescue analgesia will be noted.
次要结局
- To determine & compare between the two groups, intraoperative hemodynamic changes, postoperative pain scores & incidence of any complication(The vitals including HR, NIBP, SpO2 & end tidal carbon dioxide levels (EtCO2) will be recorded intraoperatively from the induction of anesthesia at every 15 minutes. Pain (FLACC) scoring will be done at admission in PACU, then every 30 minutes till 2 hours then at 4, 8 & 24 hours. Any complication like vomiting, bradycardia, respiratory depression will be noted)