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临床试验/NCT06667947
NCT06667947已完成不适用

Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications Following Primary Repairs: A Randomized Controlled Trial

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年7月16日最近更新:
适应症

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
2
主要终点
complication rate

研究概览

简要总结

Hypospadias is one of the most common congenital malformations in male babies, affecting approximately 1 in every 200-300 live male births. This condition is characterized by an abnormal location of the urethral meatus, located on the ventral side of the penis, anywhere from the glans to the perineum.

Treatment of hypospadias is primarily surgical and aims at functional and cosmetic correction. However, surgery is often complex and can be associated with a significant risk of complications, such as fistula formation, wound dehiscence, urethral stricture, and dissatisfaction with cosmetic results. The search for optimal surgical techniques and postoperative management strategies that can reduce these complications continues.

Postoperative pain after penile surgery can cause agitation and anxiety in children, which can also lead to stress and tension in parents. In addition to ensuring the comfort of both children and parents, pain control reduces complications in the postoperative period and accelerates recovery. Different techniques such as local anesthesia, sedoanalgesia, general anesthesia or regional anesthesia are used in penile surgery. Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, its anesthetic safety and effectiveness have been proven in recent years, and caudal block is generally applied safely to provide postoperative analgesia in these patients. These block applications reduce the need for analgesic and anesthetic drugs and prolong the pain-free period. At the same time, this method is easy and safe to apply. However, some anesthetic complications of caudal block have been reported in previous studies6. It has also been suggested that the use of caudal nerve block is a potential risk factor contributing to surgical complications in hypospadias surgeries. This was first reported by Kundra and his team in 2012. In the study, they noted that the fistula rate increased to 19.2% in patients receiving caudal nerve block compared to a 0% fistula rate in those receiving penile block during one-stage hypospadias repair. Since the initial findings of Kundra and his team, the use of caudal anesthesia during hypospadias repair has been a subject of ongoing debate.

Caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, and its safety and effectiveness as an anesthetic are well established. The purpose of this study was to evaluate the potential effect of caudal nerve block anesthesia on postoperative surgical outcomes in male patients aged 6-48 months undergoing hypospadias repair

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 48 Months(Child)
性别
Male
接受健康志愿者

入选标准

  • hypospadias

排除标准

  • the patients who alder than 48 month

结局指标

主要结局

complication rate

时间窗: 01.07.2023-01.03.2024

Surgery-related complications such as wound dehiscence, fistula formation, and urethral stenosis due to the surgical procedure will be recorded.

次要结局

未报告次要终点

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fikret Salık

Associate professor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

研究点 (2)

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