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

NCT ID: NCT07099560

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-04-30

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.

Detailed Description

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

Study Design

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

Study Groups

Arm A: Sacral Erector Spinae Plane Block (sESPB)

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.

Group Type: EXPERIMENTAL

Ultrasound-guided sacral erector spinae plane block (sESPB)

Intervention Type: 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.

Arm B - Active Comparator: Caudal Epidural Block

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.

Group Type: EXPERIMENTAL

Ultrasound-guided caudal epidural block

Intervention Type: 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.

Interventions

Ultrasound-guided sacral erector spinae plane block (sESPB)

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.

Intervention Type: PROCEDURE

Ultrasound-guided caudal epidural block

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.

Intervention Type: PROCEDURE

Other Intervention Names

sESPB; sacral ESP block; Caudal epidural block (CEB); Caudal epidural anesthesia; Caudal block

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Magdy Ahmed Elfekey

Resident of Anesthesia, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada MA Elfekey, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Tanta University, Egypt

Locations

Tanta University Hospital

Tanta, El-Gharbia Govenorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ghada MA Elfekey, MBBCH

Role: CONTACT

ghadaelfekey0@gmail.com

+201271600557

Marwa A Eloraby, MD

Role: CONTACT

marwa.elfert@med.tanta.edu.eg

+201008618309

Other Identifiers

36264MS869/3/25

Identifier Type: -

Identifier Source: org_study_id