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NCT07801794
Comparison of TAP Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery
Conditions: Postoperative Pain, Opioid Consumption
Sex: All
Ages: 1 Year – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Location: Dicle University Faculty of Medicine Hospital Diyarbakır Diyarbakır
Summary
The aim of this prospective randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided transversus abdominis plane (TAP) block and umbilical paramedian linea semilunaris block in pediatric patients undergoing elective laparoscopic abdominal surgery.
A total of 56 pediatric patients will be randomly assigned in a 1:1 ratio to receive either a TAP block or a linea semilunaris block after induction of general anesthesia and before the start of surgery. Both blocks will be performed under ultrasound guidance using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total dose limited to 2 mg/kg.
The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first analgesic requirement, additional analgesic requirements, postoperative nausea and vomiting, and block-related complications.
Eligibility Criteria
Inclusion Criteria:
* Patients scheduled for elective pediatric laparoscopic abdominal surgery
* Age within the specified eligibility range
* American Society of Anesthesiologists (ASA) physical status I or II
* Written informed consent provided by a parent or legal guardian
* Adequate ultrasound visualization for the planned regional block
* No known allergy to bupivacaine or ultrasound gel
* No coagulopathy
* No infection at the block injection site
* No previous surgery at the block injection site
* No anticipated requirement for postoperative intensive care unit admission
Exclusion Criteria:
* Refusal of the parent or legal guardian to participate
* Emergency surgery
* Inadequate ultrasound visualization
* Coagulopathy
* Infection or previous surgery at the block injection site
* Known allergy to bupivacaine or ultrasound gel
* Conversion from laparoscopic to open surgery
* Requirement for postoperative intensive care unit admission
* ASA physical status III or higher
Source: ClinicalTrials.gov (NCT07801794). StuddyBuddy aggregates publicly available trial information.