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临床试验/NCT04866368
NCT04866368Unknown不适用

Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery

Kocaeli University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
FLACC score

研究概览

简要总结

In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.

详细描述

ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 9 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital

排除标准

  • •xclusion Criteria:
  • •American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site

研究组 & 干预措施

The erector spinae plane block

Active Comparator

The ultrasound-guided Erector spinae plane block (ESPB) with 1 ml/kg 0,25 % bupivacaine at the lumbar vertebral level will perform before surgery to all patients in the ESPB group.

干预措施: The ultrasound-guided Sacral Erector spinae plane block (Procedure)

The penile block

Active Comparator

The penile block with 0,5ml/kg 0,25 % bupivacaine will be performed after the patients give standard general anesthesia and a laryngeal mask is applied.

干预措施: The dorsal penile block (Procedure)

结局指标

主要结局

FLACC score

时间窗: during postoperative 24 hour

At the end of the operation and after the patient is awakened 5th min., 30th min., 1st, 2nd, 4th, 6th, 12th, 24th Hourly FLACC pain scores will be recorded.

次要结局

未报告次要终点

研究者

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

Can AKSU

Associate professor

Kocaeli University

研究点 (2)

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