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临床试验/NCT07306806
NCT07306806已完成不适用

Comparison of Post-Operative Analgesia of Caudal Versus Dorsal Penile Nerve Blocks for Pediatric Patients Undergoing Hypospadias Repair

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Time to first rescue analgesia.

研究概览

简要总结

This prospective, randomized clinical trial conducted at Ain Shams University Hospitals evaluated the analgesic efficacy of dorsal penile nerve block versus caudal epidural block in 30 male children undergoing primary hypospadias repair. Patients were randomly assigned to the penile block group (n=15) or the caudal block group (n=15). Both groups received standardized general anesthesia. The dorsal penile nerve block was performed with 0.25% bupivacaine (1 mL/kg) via a subpubic approach, while the caudal block used 0.25% bupivacaine (0.5 mL/kg) through the sacral hiatus. Block failure was managed with intravenous fentanyl. Baseline demographics and operative duration were comparable between groups. Postoperative pain assessed using the FLACC scale showed superior early analgesia in the caudal group at 0 and 3 hours, with comparable scores at 6-12 hours. The caudal block group required rescue analgesia later and consumed lower total doses of paracetamol and pethidine within 24 hours. However, caudal block delayed ambulation compared to the penile block group. No major complications were reported. The study concludes that both blocks are safe and effective; caudal epidural provides superior early postoperative analgesia, while dorsal penile block may be preferred when early ambulation is desired.

详细描述

BACKGROUND AND RATIONALE Hypospadias repair remains one of the most common pediatric urological procedures, with thousands of cases performed annually worldwide. Despite continuous refinement of surgical techniques, perioperative pain management in this population poses consistent clinical challenges. Children undergoing hypospadias repair typically experience significant postoperative discomfort due to tissue manipulation, dissection of delicate structures, and exposure of the highly innervated penile shaft. Poorly controlled postoperative pain may lead to increased stress responses, delayed discharge, impaired healing, and difficulties with early postoperative voiding. Because pain expression in young children is complex and often non-verbal, anesthesiologists rely on validated objective scoring systems-such as the FLACC scale-to assess discomfort and guide analgesic therapy.

Regional anesthesia is widely employed as an adjunct to general anesthesia to enhance perioperative analgesia while reducing the need for systemic opioids. Among the most widely used techniques are the caudal epidural block and the dorsal penile nerve block. Each technique has distinct advantages, limitations, and implications for recovery, ambulation, and analgesic duration. Caudal block is traditionally considered the gold standard for infra-umbilical surgeries in pediatrics due to its ease of application, high success rate, and ability to provide profound postoperative analgesia. However, concerns persist regarding delayed motor recovery, urinary retention, and potential adverse hemodynamic effects.

In contrast, the dorsal penile nerve block provides targeted sensory blockade limited to the penile region, minimizing motor involvement and typically allowing earlier mobilization. It is frequently favored in ambulatory settings or when rapid recovery is required. However, its duration of action may be shorter, and there is ongoing debate about whether it can provide analgesic efficacy equivalent to caudal anesthesia following more extensive penile reconstruction, such as hypospadias repair. Given the variation in practice patterns and the lack of high-quality comparative studies in the local setting, this trial was designed to provide a head-to-head comparison of the two regional techniques under standardized anesthetic conditions. The objective was to characterize their intraoperative stability, postoperative pain control, recovery profile, need for rescue analgesia, and safety, enabling clinicians to make informed decisions tailored to patient characteristics, surgical technique, and postoperative care priorities.

STUDY DESIGN OVERVIEW This trial was designed as a prospective, randomized, and comparative clinical study conducted at the Pediatric Surgery Unit of Ain Shams University Hospitals. The study was carried out over a six-month period, following institutional ethical approval, and adhered strictly to the principles of good clinical practice and the Declaration of Helsinki. All participants were recruited consecutively from eligible children scheduled for primary hypospadias repair. A computer-generated randomization sequence was utilized to allocate patients into two equal groups receiving one of two regional anesthesia techniques. All procedures were performed by anesthesiologists with extensive experience in pediatric regional anesthesia, ensuring consistency and proficiency across techniques. A standardized perioperative protocol was applied to all cases to avoid confounding variables. General anesthesia was induced and maintained using identical agents, ventilation strategies, and monitoring parameters. The regional blocks were administered after induction but before surgical incision. Hemodynamic stability, adequacy of analgesia, and possible complications were monitored meticulously throughout the intraoperative and postoperative periods. Data collection continued for the first 24 hours after surgery, with measurements obtained at fixed postoperative intervals. Pain scores, hemodynamic variables, time to ambulation, and need for rescue analgesia were recorded using objective and validated tools. All study staff responsible for postoperative evaluation were blinded to group allocation to minimize assessment bias.

ANESTHETIC MANAGEMENT PROTOCOL A unified anesthetic protocol was implemented for all participants to ensure consistency. Upon arrival in the operating room, each child underwent inhalational induction using 8% sevoflurane in 100% oxygen. Intravenous access was then secured with an appropriately sized cannula (22-24G). Routine monitoring included electrocardiography, non-invasive blood pressure, oxygen saturation, and end-tidal CO₂. Once anesthetized, participants were intubated without the use of neuromuscular blocking agents to prevent interference with motor-based postoperative assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male children aged 1 to 8 years.
  • ASA physical status I or II.
  • Scheduled for elective distal or mid-penile hypospadias repair.
  • Under general anesthesia.
  • Written informed consent obtained from parents or legal guardians.

排除标准

  • Age < 1 year or > 8 years.
  • ASA physical status III or higher.
  • Complicated hypospadias.
  • Coagulopathy or ongoing anticoagulant therapy.
  • Known allergy or contraindication to local anesthetics.
  • Significant neurological or neuromuscular disorders affecting pain perception.
  • Vertebral anomalies.
  • Local infection at the site of injection.
  • Refusal or inability of parents/guardians to provide informed consent.

研究组 & 干预措施

Caudal epidural block

Experimental

Participants receive a single caudal epidural injection of 0.25% bupivacaine (0.5 mL/kg) via the sacral hiatus in lateral decubitus position after general anesthesia induction. Standard intraoperative monitoring and postoperative care are applied.

干预措施: Caudal epidural block (Procedure)

Dorsal penile nerve block

Experimental

Participants receive a bilateral dorsal penile nerve block with 0.25% bupivacaine (1 mL/kg divided equally) via the subpubic approach after general anesthesia induction. Standard intraoperative monitoring and postoperative care are applied.

干预措施: Dorsal Penile nerve Block (Procedure)

结局指标

主要结局

Time to first rescue analgesia.

时间窗: Within the first 24 hours postoperatively

Time elapsed from the end of surgery until the first administration of rescue analgesia.

Total 24-hrs postoperative analgesic consumption.

时间窗: Within the 24 hours postoperatively

Total amount of postoperative analgesics (paracetamol and pethidine) administered during the first 24 hours after surgery, expressed as mg/kg.

次要结局

  • Time to Ambulation(Within the first 24 hours postoperatively)
  • Postoperative Pain Score using Face, Legs, Activity, Cry, Consolability ( FLACC score)(At PACU, and 3, 6, 9, and 12 hours postoperatively.)

研究者

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

Mariam Kamal Habib

Lecturer of Anesthesiology and Critical Care

Ain Shams University

研究点 (1)

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