Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

NCT07099560 | Recruiting DMC

• 1 other identifier: 36264MS869/3/25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.

Conditions

Hypospadias; Caudal Block; Erector Spinae Plane Block; Pain, Postoperative

Keywords

hypospadias; nerve block; erector spinae plane block; caudal block; pain; ultra-sound

Outcome Measures

Primary Outcomes (1)

• FLACC pain score (0-10) during the first 24 hours after surgery

  The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.

  From immediately after surgery through 24 hours postoperatively: at the time of Post-Anesthesia Care Unit (PACU) arrival (0 hours), and at 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery.

Secondary Outcomes (4)

• Total opioid consumption (pethidine), 0-24 h (mg/kg)

  From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery.

• Time to first rescue analgesia requirement postoperatively

  From the time of arrival to the Post-Anesthesia Care Unit (0 hours) until the first rescue dose, within 24 hours after surgery

• Parent's satisfaction

  24 hours postoperatively

• Incidence of postoperative adverse events

  24 hours postoperatively

Study Arms (2)

Arm A: Sacral Erector Spinae Plane Block (sESPB)

EXPERIMENTAL

Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg/kg) if FLACC ≥4.

Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB)

Arm B - Active Comparator: Caudal Epidural Block

EXPERIMENTAL

Participants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.

Procedure: Ultrasound-guided caudal epidural block

Interventions

Ultrasound-guided sacral erector spinae plane block (sESPB) PROCEDURE

After induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg/kg if FLACC ≥4.

Also known as: sESPB, sacral ESP block

Arm A: Sacral Erector Spinae Plane Block (sESPB)

Ultrasound-guided caudal epidural block PROCEDURE

After induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.

Also known as: Caudal epidural block (CEB), Caudal epidural anesthesia, Caudal block

Arm B - Active Comparator: Caudal Epidural Block

Eligibility Criteria

• Age: 1 Year - 5 Years
• Gender Eligibility Details: Male only. Enrollment is limited to pediatric patients with male genitalia (sex assigned male at birth) undergoing hypospadias repair. Rationale: hypospadias is a congenital condition of the penis and occurs in males; therefore, females and other genders are not eligible."
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male children aged 1-5 years
• ASA physical status I-II
• Scheduled for elective hypospadias repair under general anesthesia
• Parent or legal guardian provides written informed consent

You may not qualify if:

• Parent/guardian refusal of participation
• Coagulopathy or current anticoagulant therapy
• Infection at the intended injection site (sacral/caudal region) or systemic infection
• Allergy/hypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications
• Neurologic or spinal disorders or congenital sacral anomalies affecting block safety
• Significant hepatic, renal, or cardiac disease
• Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia Govenorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Hypospadias; Pain, Postoperative; Pain

Interventions

Anesthesia, Caudal

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Epidural; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ghada MA Elfekey, MBBCH

  Faculty of Medicine, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada MA Elfekey, MBBCH

CONTACT

+201271600557; ghadaelfekey0@gmail.com

Marwa A Eloraby, MD

CONTACT

+201008618309; marwa.elfert@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management

Model Details: Two-arm, parallel assignment. Participants are randomized 1:1 after induction of anesthesia to receive either ultrasound-guided sacral erector spinae plane block or ultrasound-guided caudal epidural block. Each participant receives one procedure only (no crossover), and both groups are followed concurrently for 24 hours with standardized perioperative care. Randomization uses a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. Blocks are performed by an anesthesiologist not involved in postoperative assessments; outcome assessors are blinded to group assignment. Single-center study at Tanta University Hospitals.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)