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NCT Number: NCT07099560

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

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.

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Key information

Conditions

Hypospadias Caudal Block Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Erector Spinae Plane Block Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Postoperative Complications Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

1 year–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, El-Gharbia Govenorate, 31527, Egypt

Location status: Recruiting

Location contact

Gehan M Eid, MD

SUB_INVESTIGATOR

Marwa A ELoraby, MD

SUB_INVESTIGATOR

Osama M Shalaby, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Able to complete postoperative assessments through 24 hours after surgery 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

Treatment and study plan

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.

Other names: sESPB, sacral ESP block

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.

Other names: Caudal epidural block (CEB), Caudal epidural anesthesia, Caudal block

Primary outcomes

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

    Time frame: 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.

    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.

Secondary outcomes

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

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

    Cumulative dose of IV pethidine given as rescue analgesia when FLACC ≥4, from PACU arrival through 24 h post-op. Sum all doses per participant; no other opioids planned. Group summaries will be reported.

  2. Time to first rescue analgesia requirement postoperatively

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

    If FLACC pain score ≥ 4 I.V pethidine 0.5 mg/kg will be given as rescue analgesia.

  3. Parent's satisfaction

    Time frame: 24 hours postoperatively

    Parent's Satisfaction Level were recorded on a numerical scale from 1 to 3 (not satisfied - neutral - satisfied).

  4. Incidence of postoperative adverse events

    Time frame: 24 hours postoperatively

    Postoperative adverse events as nausea and vomiting, motor weakness, urinary retention, drowsiness, respiratory depression, hematoma or infection at the site of injection will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada MA Elfekey, MBBCH

CONTACT

[email protected]

+201271600557

Marwa A Eloraby, MD

CONTACT

[email protected]

+201008618309

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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