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临床试验/CTRI/2024/06/069516
CTRI/2024/06/069516尚未招募不适用

Comparison of different volumes of Bupivacaine for ultrasound guided sacral erector spinae block in pediatric patients undergoing hypospadias repair.

Pt B D Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Number of blocked dermatomes

研究概览

简要总结

Paediatric male patients aged 8 to 12 yrs with American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo surgery for hypospadias repair will be included in the study. All children will be evaluated one day prior to surgery. The patients will be instructed on usage of pin prick method for dermatomal spread and a 10mm visual analog scale (VAS) for pain [graded from 0 ( no pain) to 10 ( most severe pain) during preoperative evaluation .From computer generated randomization, patients will be randomly allocated to one of the two groups comprising of thirty patients. Inhalational induction of anaesthesia will be done in a standardized manner to facilitate the placement of supraglottic airway device. Group I (n=30) will be given ultrasound guided sacral erector spinae plane block with 1 mlkg-1 of 0.25% bupivacaine. Group II(n=30) will be given ultrasound guided sacral erector spinae plane block with 0.75 mlkg-1 of 0.25% bupivacaine . Number of blocked dermatomes will be assessed at 30 mins, 45 mins, 60 mins using pin prick method. Pain assessment will be done postoperatively using VAS score at 0 hr, every 15 mins upto 1 hr, every half an hour upto 2 hours, 2 hrly upto 12 hours and then at 18th hour and 24 th hour postoperatively. Rescue analgesic will be given at VAS score 4. Patient will be given 15mgkg-1 paracetamol infusion over 10 min but not more frequently than 6 hours. If pain persists after paracetamol administration, oral ibuprofen 10mgkg-1 will be given but not more frequently than 8 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
8.00 Year(s) 至 12.00 Year(s)(—)
性别
Male

入选标准

  • Pediatric patients aged 8-12 years of age with ASA grade I and II scheduled for hypospadias repair.

排除标准

  • Patients with 1: weight more than 25 kg 2: history of developmental delay, 3: allergic reactions to any local anaesthetic, 4: infection at puncture site, 5: anatomical deformity at local site, 6: bleeding disorders or on anticoagulants 7: parental refusal.

结局指标

主要结局

Number of blocked dermatomes

时间窗: Number of blocked dermatomes will be assessed at 30 mins, 45 mins, 60 mins using pin prick method

次要结局

  • 1) Postoperative pain score using Visual analogue score (VAS) Scale(2) Postoperative analgesic consumption in 24hrs)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Teena Bansal

Pt B D Sharma PGIMS

研究点 (1)

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