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

NCT ID: NCT07306806

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-04-01

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.

Detailed Description

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.

After induction and stabilization, regional anesthesia was performed according to the group assignment. All techniques were executed under sterile conditions using using isoflurane (1-2%) in a mixture of oxygen and air. Ventilation parameters were adjusted to maintain normocapnia. Throughout surgery, continuous monitoring allowed detection of inadequate analgesia. A >20% rise from baseline in mean arterial pressure or heart rate was considered indicative of insufficient block. In such cases, fentanyl 1 µg/kg was administered, and the participant was subsequently excluded from per-protocol analysis to ensure the study accurately reflected the analgesic performance of each regional technique. At the end of surgery, inhalational agents were discontinued, and extubation was performed once all criteria were met, including adequate spontaneous breathing, protective reflexes, and hemodynamic stability. Patients were then transferred to the post-anesthesia care unit (PACU) for initial recovery and postoperative monitoring. DPB is designed to target the primary sensory nerves of the penis at the most proximal location accessible extracorporeally, maximizing analgesic coverage of the penile shaft and glans. It minimizes motor involvement, preserves lower-limb function, and is well suited for early mobilization. Caudal block provides sensory and motor blockade to the lumbosacral dermatomes, ensuring extensive analgesia for penile and perineal surgeries. Its principal advantage is its prolonged analgesic duration, although transient motor impairment may delay ambulation.

PERIOPERATIVE MONITORING AND SAFETY OVERSIGHT

Intraoperative monitoring continued throughout the procedure, with recordings of heart rate, mean arterial pressure, oxygen saturation, and end-tidal CO₂ at predetermined intervals. Any adverse events, such as hypotension, bradycardia, local anesthetic systemic toxicity, arrhythmias, or signs of block-related complications, were documented. Postoperative monitoring focused on detecting pain, hemodynamic alterations, sedation levels, nausea, vomiting, urinary retention, motor impairment, and block-related complications. All assessments were performed in the PACU and continued in the ward at 3, 6, 9, and 12-hour intervals, with additional observations made as clinically necessary. Pain assessment utilized the FLACC scale because of its reliability and effectiveness in non-verbal and preverbal pediatric populations. All nurses and assessors were trained in FLACC scoring to avoid inter-observer variability.

DATA COLLECTION AND MANAGEMENT All collected data, including demographic variables, perioperative measurements, and postoperative findings, were entered into standardized data sheets and subsequently transferred to a secure electronic database. Data accuracy was verified by dual-entry validation. Confidentiality of participant information was strictly maintained, with de-identified codes used for all analyses.

STATISTICAL HANDLING AND ANALYTIC FRAMEWORK Quantitative variables were initially assessed for normality using the Shapiro-Wilk test. Parametric data were analyzed using the independent-samples t-test to compare means between the two groups. Non-parametric variables, including FLACC scores, were analyzed using the Mann-Whitney U test. Categorical variables, such as ASA status, were analyzed using the chi-square test. A 95% confidence interval and significance threshold of p < 0.05 were applied.

STUDY FLOW AND CLINICAL OBSERVATIONS The flow of participants from recruitment through follow-up was documented in accordance with CONSORT guidelines. No block-related complications, such as hematoma, infection, or systemic toxicity, were observed. Both regional techniques demonstrated favorable safety profiles. Clear differences emerged between the two groups in postoperative hemodynamics, pain trajectories, timing of rescue analgesia, and recovery parameters. These findings provided robust comparative insights into the performance of each regional anesthesia modality under consistent surgical and anesthetic conditions.

INTERPRETATION AND CLINICAL SIGNIFICANCE The trial revealed distinct advantages and limitations of each regional technique. Caudal block offered superior early postoperative analgesia and significantly prolonged the time to first analgesic requirement. It also resulted in reduced total consumption of rescue analgesics within 24 hours. These outcomes highlight its value in situations where extended postoperative pain control is a clinical priority. However, the caudal block was associated with delayed ambulation, likely resulting from transient motor involvement in the lower limbs. This consideration is crucial in fast-track surgical settings or when early mobilization is required. The dorsal penile nerve block provided effective analgesia with shorter recovery time and earlier ambulation, making it an appropriate choice for ambulatory care or settings aiming for rapid discharge.

The findings underscore the importance of individualized analgesic planning based on the surgical context, patient characteristics, and recovery goals. Both blocks are safe and effective when performed by skilled practitioners.

CONCLUSION This detailed clinical investigation provides comprehensive comparative data on two widely used regional anesthesia techniques for hypospadias repair. By standardizing anesthetic management, surgical technique, and postoperative assessment, the study establishes strong evidence to guide pediatric pain management and optimize perioperative outcomes.

Conditions

Hypospadias Repair; Pediatric Anesthesia; Postoperative Analgesia

Keywords

DPB vs caudal block in hypospadius repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Caudal epidural block

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.

Group Type: EXPERIMENTAL

Caudal epidural block

Intervention Type: 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.

Dorsal penile nerve block

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.

Group Type: EXPERIMENTAL

Dorsal Penile nerve Block

Intervention Type: 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.

Interventions

Caudal epidural block

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.

Intervention Type: PROCEDURE

Dorsal Penile nerve Block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Kamal Habib

Lecturer of Anesthesiology and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam K Habib, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

intensive care unit Department, Ain Shams University Hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU MS 575/ 2021

Identifier Type: -

Identifier Source: org_study_id