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临床试验/CTRI/2023/04/051388
CTRI/2023/04/051388已完成不适用

Ultrasound-Guided sacral erector spinae plane block versus caudal epidural block for postoperative analgesia in children undergoinghypospadias surgery: Randomized controlled study

AIIMS Raipur1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年11月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Postoperative pain intensity by FLACC scale

研究概览

简要总结

Hypospadias occurs in 1 in 200 new born males and its correction is one of the most common Urological surgeries performed in children [1]. Various methods and medications that have Been tried to provide postoperative pain relief in the paediatric population can be associated Side effects. Use of opioid in paediatrics shows somnolence, vomiting and also respiratory Depression as an alarming side effect [2].Regional analgesia utilized for this penile reconstructive surgery is typically either a caudal Or dorsal penile nerve block. Caudal blocks are the most commonly performed blocks in Children undergoing pelvic genitourinary surgery and are frequently performed for Hypospadias surgery [3].Caudal injection through the sacral hiatus is easy to perform. For most of the year’s caudal Block is considered to be effective in further prolonging postoperative analgesia. However,Variations in sacral anatomy, the potential for coagulopathy and the possible infection risks Contribute to the complexity of application and success of the block. Caudal block may also Lead to some complications like motor block, urinary retention, block failure, blood Aspiration, and intra- vascular injection. [2]Nowadays, the use of ultrasound (US)-guided nerve block resulted in the revolutionary Change in the field of regional anaesthesia in paediatrics. Many truncal blocks are used for Both upper and lower abdominal surgeries with a high success rate [4]. Nerve blockade has Been shown to be as effective as caudal block for infra umbilical surgeries. Recent literature Suggests that, as an alternative method, peripheral nerve blocks have longer analgesia Duration and fewer adverse effects than neuraxial blocks [5,6]Erector spinae plane block (ESPB) was first described by Foreroin 2016 as an interfascial

plane block which was 1st performed at the upper thoracic levels for the treatment of thoracic neuropathic pain; eventually it was used in lower thoracic and lumbar levels.ESP block carries promise as a simpler and safer alternative to caudal block. The efficacy of this technique for the management of acute and chronic pain in the thoracic region is reported to be effective [7,8]. Case reports on sacral ESP block states that sacral erector spinae plane block provides surgical anaesthesia in ambulatory anorectal surgery [18].ESP block when used in paediatric patients presenting for hip surgery improved the postoperative analgesia. Therefore, we consider that in sacral region, it may have the same anatomical considerations to get good result.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
Male

入选标准

  • from 1 yr of age to 6 yr of age.

排除标准

  • Patients parents refusal Patients with any contraindications to regional anaesthesia History of development delay or mental retardation, which will make observational pain intensity assessment difficult History of allergic reaction to local anaesthetic Rash or skin infection at the site of injection Anatomical abnormalities Bleeding diathesis Coagulation disorder History of renal, hepatic, cardiac disorder, upper or lower infection or any neurological abnormalities.

结局指标

主要结局

Postoperative pain intensity by FLACC scale

时间窗: Postoperative pain intensity by FLACC scale

次要结局

  • Total analgesic requirement(It is the duration required for 1st rescue postoperative analgesia)

研究者

发起方
AIIMS Raipur
申办方类型
Research institution and hospital

研究点 (1)

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