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NCT07916233
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Conditions: Inguinal Hernia, Postoperative Pain
Sex: All
Ages: 2 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Beni-Suef University
Location: Beni-Suef University Hospital Banī Suwayf
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Children aged 2 to 8 years at the time of enrollment.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Scheduled for elective unilateral open inguinal hernia repair as day-case or short-stay surgery.
* Body weight between 10 kg and 35 kg (to ensure local anesthetic dosing remains within predefined safe exposure limits).
* Written informed consent provided by parents or legal guardians, and age-appropriate assent from children where developmentally feasible.
Exclusion Criteria:
* Refusal of trial participation by parents or legal guardians.
* Known allergy, hypersensitivity, or contraindication to amide local anesthetics, paracetamol, or ibuprofen.
* Coagulopathy, bleeding disorder, or current anticoagulant/antiplatelet therapy.
* Active localized infection at or near either planned injection site (paraspinal or lateral abdominal wall).
* Pre-existing neurological, neuromuscular, or spinal disease affecting the lower limbs or trunk.
* Significant hepatic, renal, or cardiac dysfunction.
* Severe cerebral palsy, developmental delay, or neurobehavioral disorders resulting in abnormal baseline tone or movement that would render behavioral pain scoring (FLACC) unreliable.
* Bilateral inguinal hernia repair (due to bilateral block considerations).
* Previous participation in this clinical trial.
Source: ClinicalTrials.gov (NCT07916233). StuddyBuddy aggregates publicly available trial information.