Analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block versus Caudal epidural Block in pediatric patients undergoing urethroplasty under general anesthesia: a randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- FLACC that is face legs activity cry consolability scale score at different time
研究概览
简要总结
Analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block versus Caudal epidural Block in pediatric patients undergoing urethroplasty under general anesthesia: a randomized controlled study is my study title. Aim of our study is to compare the analgesic efficacy of ultrasound guided sacral erector spinae plane block versus caudal epidural block in pediatric patients undergoing urethroplasty under general anesthesia. Primary objective is to determine and compare effect on intra and post-operative analgesia over the 1st 24 hrs after surgery. A total sample size of 60 patients with age group 1-8yrs will be recruited in the study and divided into two groups one with ultrasound guided sacral Erector Spinae Plane Block and the other with ultrasound guided caudal block each group consisting of 30 patients. Erector Spinae Plane Block group patient will be positioned in the lateral position for block. Under all aseptic precautions, USG guided (7–13 MHz linear probe on the Sonosite™ MTurbo) erector spinae plane block will be given with echogenic 5 cm 22 G needle at the 3rd - 4th median crest with 0.25% bupivacaine (1ml/kg) combined with dexmedetomidine 1mcg/kg after negative aspiration. In caudal epidural block group patient will be positioned in the lateral position for the caudal block. Under all aseptic precautions USG guided caudal epidural block will be given using 0.25% bupivacaine 1 ml/kg volume with dexmedetomidine 1mcg/kg. FLACC (face, legs, activity, cry, consolability) scale score at different time points- 0 h, 1 h, 2, 6, 12 and 24, 36, 48 h postoperatively. Will determine and compare intra operative opioid consumption , time to rescue analgesia in post operative period (in hours) , Parental satisfaction score, Stress response measured by taking baseline and 24 hrs salivary cortisol levels, Occurrence of bladder spasm post operatively in the first 24 hours postoperatively , Time to achieving DrEaMing bundle (Drinking, eating and mobilising bundle).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- Male
入选标准
- •Consenting parents or guardians • Children from 1 to 8 years of age • Undergoing urethroplasty surgery with plan of anesthesia as general anesthesia with a regional block • ASA 1 and 2 patients.
排除标准
- •Allergy to the study drugs • Infection or skin changes at the puncture site • Vertebral anomalies • Syndromic association • We wish to exclude age less than 1 year due to technical difficulties expected in this age group and more than 8yrs due to the expected anatomical difficulties during caudal epidural block because of progressive ossification of sacrococcygeal ligament).
结局指标
主要结局
FLACC that is face legs activity cry consolability scale score at different time
时间窗: at 0hour 1h 2 6 12 and 24 36 48 hours postoperatively
points
时间窗: at 0hour 1h 2 6 12 and 24 36 48 hours postoperatively
次要结局
- To determine and compare between above 2 groups(• Intra operative opioid consumption)
研究者
Dr Roopa
All Institute Of Medical Sciences Bhopal