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临床试验/NCT06373185
NCT06373185已完成不适用

Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases

Giresun University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Face, Leg, Activity, Cry, Consolability (FLACC) score

研究概览

简要总结

The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

详细描述

The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed.

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 1-7 years undergoing paediatric urogenital surgery
  • Patients in American Society of Anesthesiologist (ASA) class I-II

排除标准

  • Patients whose parents do not give consent
  • Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
  • Patients with known local anaesthetic allergy
  • Patients for whom regional anaesthesia is contraindicated
  • Known neurological or muscular disease

结局指标

主要结局

Face, Leg, Activity, Cry, Consolability (FLACC) score

时间窗: baseline ,and 24 hours

The FLACC is an observational pain scale. It is widely used in the paediatric population to assess pain in infants and children who are unable to verbally express their pain.Each category is scored on the 0-2 scale which results in a total score of 0-10.

次要结局

  • Analgesic requirement(baseline, and 24 hours)
  • Satisfaction of the patient's parents(24. hours)
  • Satisfaction of the surgeons(24.hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bilge Olgun Keles

Assistant Professor

Giresun University

研究点 (2)

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