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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal of the parent or legal guardian to participate

Emergency surgery

Inadequate ultrasound visualization

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Transversus Abdominis Plane Block

    Procedure/Surgery

    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.

  • Ultrasound-Guided Linea Semilunaris Block

    Procedure/Surgery

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: USG Guided Transversus Abdominis Plane BlockActive comparator 1 intervention
Group B: USG Guided Linea Semlunaris BlockExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
First 24 hours after surgery

Secondary outcomes

1

Postoperative Pain Scores

Postoperative pain intensity will be assessed using age-appropriate pain assessment scales (FLACC or Wong-Baker Faces Pain Rating Scale).

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

Other outcomes

Sponsors and contacts

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