An interventional study of Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) and Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Inguinal Hernia and Postoperative Pain, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
This study evaluates two ultrasound-guided nerve block techniques-Erector Spinae Plane Block (ESPB) and Transversus Abdominis Plane (TAP) block-for pain relief in children undergoing elective open inguinal hernia repair.
Children aged 2 to 8 years scheduled for unilateral open inguinal hernia surgery under general anesthesia will be randomly assigned to receive either a lumbar ESP block or a TAP block before surgery begins. Both groups will receive standardized pain management with non-opioid pain relievers (paracetamol and ibuprofen).
The main goal of the study is to compare how long each nerve block provides effective pain relief before the child requires additional pain medication (rescue opioid) within the first 24 hours after surgery. The study will also assess overall pain scores, total opioid consumption, postoperative recovery, and safety.
Effective postoperative analgesia is essential in pediatric open inguinal hernia repair to attenuate the surgical stress response, facilitate early ambulation, and enable same-day discharge. While caudal epidural block has traditionally served as the standard regional technique in pediatric lower abdominal surgery, concerns regarding motor block, urinary retention, and rare neuraxial complications have driven interest toward peripheral ultrasound-guided fascial plane blocks.
Ultrasound-guided Transversus Abdominis Plane (TAP) block provides somatic analgesia to the anterolateral abdominal wall by targeting the anterior rami of lower thoracolumbar spinal nerves (T10-L1). Recent meta-analyses demonstrate that TAP block prolongs analgesia duration and reduces rescue opioid requirements compared to caudal blockade.
Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB) is an interfascial plane technique where local anesthetic deposited deep to the erector spinae muscle at the L1 transverse process produces craniocaudal spread, blocking dorsal and ventral rami. Recent trials suggest lumbar ESPB provides effective somatic analgesia, but the degree of visceral inguinal coverage via genitofemoral and ilioinguinal pathways remains debated.
Direct, prospective head-to-head comparisons between ultrasound-guided lumbar ESPB and TAP block in pediatric open inguinal hernia repair remain limited-particularly studies utilizing a double-blind methodology, standardized multimodal analgesia, and identical local anesthetic dosing.
This prospective, randomized, double-blind controlled trial aims to compare the duration and quality of postoperative analgesia provided by ultrasound-guided lumbar ESPB versus TAP block using bupivacaine 0.25% (0.5 mL/kg, maximum 20 mL) in children aged 2-8 years undergoing elective unilateral open inguinal hernia repair under general anesthesia. The primary hypothesis is that lumbar ESPB is non-inferior to TAP block with respect to time to first rescue analgesia within 24 hours postoperatively.
567 studies on the registry are indexed under Hernia, Inguinal; 80 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 420 interventional studies indexed under Hernia, Inguinal.
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Children in Group E receive an ultrasound-guided lumbar erector spinae plane block (ESPB) performed in the lateral decubitus position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane to contact the L1 transverse process deep to the erector spinae muscle. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding.
Procedure: Ultrasound-guided Lumbar Erector Spinae Plane Block (ESPB)
Children in Group T receive an ultrasound-guided transversus abdominis plane (TAP) block performed in the supine position prior to surgical incision following general anesthesia induction. A 22-gauge 50-mm echogenic needle is advanced in-plane into the fascial plane between the internal oblique and transversus abdominis muscles at the mid-axillary line. After negative aspiration and hydrodissection verification with 1-2 mL saline, bupivacaine 0.25% at a volume of 0.5 mL/kg (maximum 20 mL; total dose 1.25 mg/kg) is injected incrementally. Identical sterile dressings are applied over both the paraspinal and abdominal block sites to maintain blinding.
Procedure: Ultrasound-guided Transversus Abdominis Plane (TAP) Block
Single-shot ultrasound-guided lumbar ESP block performed at the L1 transverse process level using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg) deposited deep to the erector spinae muscle. Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively.
Also known as: L-ESPB
Single-shot ultrasound-guided TAP block performed between the internal oblique and transversus abdominis muscles at the mid-axillary line using bupivacaine 0.25% at 0.5 mL/kg (maximum 20 mL, total dose 1.25 mg/kg). Administered after general anesthesia induction and before surgical incision. Standardized multimodal background analgesia (IV paracetamol 15 mg/kg q6h ± oral/IV ibuprofen 10 mg/kg q8h) is co-administered postoperatively.
Also known as: TAP block
Time to First Postoperative Rescue Analgesia Request
Measured as the duration (in hours) from the end of general anesthesia (tracheal extubation) until the first administration of rescue opioid. Rescue analgesia is triggered when a trained blinded observer records a Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain score greater than 3 on two consecutive assessments separated by 15 minutes.
Time frame: Up to 24 hours postoperatively
Postoperative FLACC Pain Scores
Assessed using the validated Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale (total score range: 0 to 10; higher scores indicate greater pain intensity). Recorded at discrete in-hospital time points.
Time frame: At PACU arrival (0 hours), 1, 2, 4, and 6 hours postoperatively
Area Under the Curve (AUC) of Postoperative FLACC Pain Scores
Calculated using the trapezoidal rule from serial FLACC pain scores (range 0-10) recorded over the first 6 post-anesthesia hours to derive cumulative pain exposure (score·hours).
Time frame: From PACU arrival (0 hours) through 6 hours postoperatively
Percentage of Participants Requiring Postoperative Rescue Opioids
Measured as the proportion of participants in each group who receive at least one dose of rescue opioid analgesia within the observation window.
Time frame: Up to 24 hours postoperatively
Total Cumulative 24-Hour Postoperative Opioid Consumption
Cumulative intravenous and oral rescue opioid consumption converted to standard Morphine Milligram Equivalents per kilogram of body weight (MME/kg).
Time frame: 24 hours postoperatively
Total Intraoperative Fentanyl Consumption
Total dose of intravenous fentanyl administered intraoperatively for rescue hemodynamic responses (heart rate or mean arterial pressure \> 20% above baseline), expressed in micrograms per kilogram (µg/kg).
Time frame: Intraoperatively (from surgical incision to skin closure)
Incidence of Postoperative Nausea and Vomiting (PONV)
Percentage of participants experiencing at least one episode of postoperative nausea or vomiting requiring antiemetic treatment.
Time frame: Up to 24 hours postoperatively
Time to First Mobilization
Measured in hours from the end of anesthesia to first unassisted/age-appropriate ambulation
Time frame: Up to 24 hours postoperatively
Parental Satisfaction Score at 24 Hours
Assessed via structured telephone follow-up using a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied; higher scores indicate greater satisfaction).
Time frame: 24 hours postoperatively
Incidence of Block-Related and Anesthetic Adverse Events
Percentage of participants experiencing block-related or systemic complications, including local anesthetic systemic toxicity (LAST), vascular puncture, hematoma, local infection, pneumothorax, or urinary retention requiring catheterization.
Time frame: Up to 24 hours postoperatively
Incidence of Postoperative Lower Extremity Motor Blockade
Assessed using a modified Bromage scale or age-appropriate motor strength score (ability to flex knees and ankles) prior to discharge to confirm complete absence of lower limb motor weakness.
Time frame: At PACU arrival, 2 hours postoperatively, and prior to discharge (up to 24 hours)
Time to Hospital Discharge Readiness
Measured as the time duration (in hours) from the end of general anesthesia (extubation) until achievement of standard discharge criteria (Modified Aldrete score ≥ 9, stable vital signs for ≥ 1 hour, FLACC pain score ≤ 3 on scheduled non-opioid analgesics alone, adequate oral fluid intake without intractable nausea or vomiting, and absence of active surgical or regional block complications
Time frame: Up to 24 hours postoperatively
Plan to share: Yes — De-identified individual participant data collected during the trial, including baseline demographic characteristics, primary outcome measurements (time to first rescue analgesia), serial FLACC pain scores, cumulative opioid consumption, and recorded adverse events, will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available starting 6 months after publication of the main study results in a peer-reviewed journal and will remain accessible for up to 36 months following publication.
Access criteria: Data will be shared with qualified academic investigators for secondary meta-analyses or scientific inquiries. Requests must be submitted directly via email to the principal investigator (Dr. Kerollos Moneer Neseem Mikhael). Provision of data will require a formal data-use agreement and institutional approval from Beni-Suef University Faculty of Medicine.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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