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NCT Number: NCT06667947

Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications

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

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Key information

Age range

6 month–48 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dicle University

Sur, Di̇yarbakir, (507) 621-4125, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hypospadias

Exclusion criteria

  • the patients who alder than 48 month

Treatment and study plan

Caudal block

Procedure

For the caudal block, a caudal needle was used by the same anesthesiologist after the patients were placed in the left lateral decubitus position.

Other names: penile block

Primary outcomes

  1. complication rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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