Comparison of TAP Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery

NCT07801794 | Not Yet Recruiting

• 1 other identifier: 398
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Opioid Consumption

Keywords

Pediatric Anesthesia; Pediatric Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Opioid Consumption During the First 24 Hours

  Total opioid consumption administered for postoperative analgesia will be recorded during the first 24 hours after surgery.

  First 24 hours after surgery

Secondary Outcomes (1)

• Postoperative Pain Scores

  At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively

Study Arms (2)

USG Guided Transversus Abdominis Plane Block

ACTIVE COMPARATOR

Participants randomized to this group will receive an ultrasound-guided transversus abdominis plane (TAP) block after induction of general anesthesia and before the start of surgery. The block will be performed using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.

Procedure: Ultrasound-Guided Transversus Abdominis Plane Block

USG Guided Linea Semlunaris Block

EXPERIMENTAL

Participants randomized to this group will receive an ultrasound-guided umbilical paramedian linea semilunaris block after induction of general anesthesia and before the start of surgery. After identification of the linea semilunaris and confirmation of the target plane by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.

Procedure: Ultrasound-Guided Linea Semilunaris Block

Interventions

Ultrasound-Guided Linea Semilunaris Block PROCEDURE

Following induction of general anesthesia and before the start of surgery, an ultrasound-guided umbilical paramedian linea semilunaris block will be performed. The linea semilunaris will be identified under ultrasound guidance, and the appropriate fascial plane will be confirmed by hydrodissection. Subsequently, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.

USG Guided Linea Semlunaris Block

Ultrasound-Guided Transversus Abdominis Plane Block PROCEDURE

Following induction of general anesthesia and before the start of surgery, an ultrasound-guided transversus abdominis plane (TAP) block will be performed. After identification of the target fascial plane and confirmation by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.

USG Guided Transversus Abdominis Plane Block

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Dicle University Faculty of Medicine Hospital

Diyarbakır, Diyarbakır, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Fikret Salik, MD

CONTACT

+905076214125; fikretsalik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)