Comparison of single injection of erector spinae plane block and paravertebral block in reducing post operative pain in children: a prospective, double blinded, randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the difference in the pain in children aged 1 to 15 years undergoing open pyeloplasty or simple nephrectomy, after receiving single injection of either erector spinae plane block or paravertebral block intra operatively.
研究概览
简要总结
BACKGROUND: Postoperative pain is an inevitable consequence of surgery even in children. Thelength of the incision causes significant post operative pain in children afterpyeloplasty and simple nephrectomy. Both erector spinae plane block and paravertebralblock have been proven to be effective in providing post operative analgesia.However no comparison studies have been done on their analgesic efficacy.
AIM: We aimto compare the effects of single injection of erector spinae plane block and paravertebralblock on post operative pain and analgesic requirements in children after openpyeloplasty and simple nephrectomy.
STUDY DESIGN: doubleblinded, prospective, randomised controlled trial
MATERIAL AND METHODS: a totalof100 American society ofAnesthesiologists physical status 1 and 2 paediatric patients, aged 1-15 years, scheduled to undergo open pyeloplasty or simple nephrectomy will berandomly allocated to receive either erector spinae plane block (Group A: n =50) or paravertebral block (Group B: n=50) with 0.2% ropivacaine 0.8ml/kg and0.5ml/kg respectively pre operatively post induction of general anesthesia. Astandard protocol will be used to provide general anesthesia. Post operativelyFLACC (faces, legs, activity, cry, consolability) score or VAS (visual analogscore) will be used for pain assessment according to age of the patient at 0,1, 2, 6, 12, 18, 24, 36, 48 hours and one week later on follow up. The time tofirst rescue analgesia, total analgesic requirement, time taken to perform theblocks, intraoperative hemodynamic changes and post operative parental andsurgeon satisfactions will be assessed. Data collected will be entered inEpidata software and analysed.
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
- 1.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I, II
- •children of age group 1-15 years
- •patients undergoing pyeloplasty or simple nephrectomy.
排除标准
- •Infection at the site of injection
- •Coagulopathy
- •Abnormal anatomy
- •Allergy to local anesthetics.
结局指标
主要结局
To compare the difference in the pain in children aged 1 to 15 years undergoing open pyeloplasty or simple nephrectomy, after receiving single injection of either erector spinae plane block or paravertebral block intra operatively.
时间窗: upto 48 hours postoperatively
次要结局
- To compare the time to first post operative rescue analgesia and the total dose of post operative analgesics needed in the first 48 hours after operation in both groups.(upto 48 hours postoperatively)
- To compare the time needed to perform the blocks under ultrasound.(intraoperatively)
- To compare the effect of the blocks on hemodynamic changes from baseline, during skin incision, at 15 minutes interval intraoperatively till the procedure is over.(intraoperatively)