Caudal vs Dorsal Penile Nerve Block for Postoperative Analgesia in Children Undergoing Hypospadias Repair (CaD-DPNB)

NCT07306806 | Completed

• 1 other identifier: FMASU MS 575/ 2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias Repair; Pediatric Anesthesia; Postoperative Analgesia

Keywords

DPB vs caudal block in hypospadius repair

Outcome Measures

Primary Outcomes (2)

• Time to first rescue analgesia.

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

  Within the first 24 hours postoperatively

• Total 24-hrs postoperative analgesic consumption.

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

  Within the 24 hours postoperatively

Secondary Outcomes (2)

• Postoperative Pain Score using Face, Legs, Activity, Cry, Consolability ( FLACC score)

  At PACU, and 3, 6, 9, and 12 hours postoperatively.

• Time to Ambulation

  Within the first 24 hours postoperatively

Study Arms (2)

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.

Procedure: Caudal epidural block

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.

Procedure: Dorsal Penile nerve Block

Interventions

Caudal epidural block PROCEDURE

A caudal epidural block was performed after induction of general anesthesia with the patient in the lateral decubitus position. A 22-G needle was inserted through the sacral hiatus into the caudal epidural space after loss of resistance of the sacrococcygeal membrane. Bupivacaine 0.25% at a dose of 0.5 mL/kg was injected following negative aspiration.

Caudal epidural block

Dorsal Penile nerve Block PROCEDURE

A dorsal penile nerve block was performed after induction of general anesthesia using the subpubic approach with the patient in the supine position. A 22-G needle was inserted bilaterally at the 10 and 2 o'clock positions near the base of the penis after gentle caudal traction. After negative aspiration, bupivacaine 0.25% at a dose of 1 mL/kg, divided equally on both sides, was injected to block the dorsal penile nerves.

Dorsal penile nerve block

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

intensive care unit Department, Ain Shams University Hospital

Cairo, Cairo Governorate, 11517, Egypt

Location

Study Officials

• Mariam K Habib, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology and Critical Care

Model Details: This study follows a randomized parallel-group interventional model comparing two established regional anesthesia techniques: caudal block and dorsal penile nerve block. Participants are randomly allocated in a 1:1 ratio using concealed assignment to ensure unbiased group distribution. Each participant receives only the technique assigned, with no crossover permitted. Standardized protocols are applied for induction, drug dosing, positioning, and monitoring to minimize procedural variability. Outcome assessors and data collectors are blinded to group allocation whenever feasible. Both groups follow identical perioperative timelines, including preoperative evaluation, intraoperative monitoring, and postoperative pain assessment. This model allows a controlled and unbiased comparison of the efficacy, safety, and clinical performance of the two techniques under uniform conditions.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: September 28, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Start Date: Upon publication of the study results. End Date: 5 years after publication.
• Access Criteria: Qualified researchers who provide a methodologically sound proposal and have obtained approval from the study investigators will be able to access the de-identified individual participant data and relevant supporting documents. Requests should be submitted via email to the corresponding author, and data will be shared under a data use agreement ensuring confidentiality and proper use.

Locations

EG (1)