A double blinded randomised controlled study on the effectiveness of post operative analgesia - comparison between ultrasound versus anatomical landmark technique of blocking bilateral maxillary nerve (suprazygomatic branch) in pediatric patients undergoing cleft lip and palate repair.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- SRM
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Adequacy for pain relief assessed by FLACC score for postoperative pain.
研究概览
简要总结
A total of 70 patients belonging to age group 6months to 7years , ASA class I and II scheduled for cleft palate repair procedures will be prospectively studied. In this double-blinded randomized control trial, a total of 70 participants will be allocated into two groups - GROUP A ( ultrasound guidance) and GROUP B(anatomical landmark technique). Both groups will recieve block with 0.25% Ropivacaine(2mg/kg) with Dexmedetomidine(0.3mcg/kg) with maximal dose of 5ml(on each side) in paediatrics patients undergoing cleft palate repair. All children will be assessed for primary outcomes of postoperative pain (FLACC score) . Data collection will be done by observation and measurement of various parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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 undergoing Primary Cleft defect repair.
- •Aged 6 months to 7 years Both sexes Elective Surgeries.
排除标准
- •ASA III (asthma with marked stridor, asd>5mm, unrepaired VSD, TOF, Eisenmenger syndrome, bleeding disorder) infection at the injection site, allergy to the local anesthetics, associated syndromes producing facial anomalies, Parents refusal.
结局指标
主要结局
Adequacy for pain relief assessed by FLACC score for postoperative pain.
时间窗: 2hr, 4hr, 6hr, 8hr, 10hr, 12hr, 14hr, 16hr, 18hr, 20hr, 22hr, 24hr
次要结局
- 1. Time taken to administer the block(2. The total amount of rescue analgesic requirements during first the 24 h)