Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

NCT07256535 | Not Yet Recruiting

• 1 other identifier: KAEK/18.bI.07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Analgesia methods such as systemic analgesics, quadratus lumborum block, and transversus abdominis plane block are used for pain management after lower abdominal surgery. Quadratus lumborum block (QLB) requires the patient to be in the lateral decubitus position, and the drug injection point is deeper. Transversus abdominis plane (TAP) block, on the other hand, can be performed with the patient supine, and the drug injection point is more superficial. However, while TAP block has no effect on visceral pain, QLB is also effective in visceral pain. Furthermore, although the injection point for QLB is deep, systemic absorption of the drug is expected to be lower than with TAP block due to its distance from vascular structures. Consequently, blood local anesthetic concentrations and the risk of local anesthetic systemic toxicity (LAST) are also expected to be lower. Despite the deeper injection, it is expected to provide better analgesia and a lower risk of LAST, making it superior to TAP block. This study aimed to compare the postoperative pain relief effect of quadratus lumborum block and transversus abdominis plane block, routinely performed in the clinic to prevent postoperative pain in pediatric patients undergoing inguinal hernia surgery, using the FLACC (Face, Leg Mobility, Activity, Crying, and Consolability) score for blood bupivacaine dose after drug injection. Based on these data, if lower blood drug concentrations are detected in patients undergoing QLB, the investigators aim to implement this technique routinely in clinical practice.

Conditions

Blood Bupivacaine Concentration

Keywords

Pediatric Population; Transversus Abdominis Plan Block; Quadratus Lumborum Block; Bupivacaine

Outcome Measures

Primary Outcomes (2)

• Blood bupivacaine level

  After the block application, 2 mL of blood will be taken into a routine biochemistry tube and the blood bupivacaine level will be measured.

  30 and 60 minutes after block application

• FLACC (Face, Leg Mobility, Activity, Crying, Consolation)

  To compare postoperative pain efficacy with FLACC (Face, Leg Mobility, Activity, Crying, Consolability) Minimum score is 0 (no pain), maximum score 10 (the worse pain).

  0.HOUR, 1.HOUR, 2.HOUR, 4.HOUR, 6.HOUR, 12.HOUR 24.HOUR

Study Arms (2)

GROUP USING Transversus Abdominis Plane Block

ACTIVE COMPARATOR

After induction of general anesthesia in all patients, once airway security is ensured, the standard regional anesthesia technique will be performed under ultrasound guidance by the same physician. A transversus abdominis plane block will be performed using an in-plane approach, passing through the external oblique and internal oblique muscles visible on ultrasound, and then advancing toward the fascial layer separating the internal oblique and transversus abdominis muscles. Following the block, the surgical team will begin the procedure. Thirty and sixty minutes after the block, 2 mL of blood will be collected into a routine biochemistry tube, and the blood bupivacaine level will be measured.

Procedure: Transversus Abdominis Plane Block

GROUP USING Quadratus Lumborum Block

ACTIVE COMPARATOR

After induction of general anesthesia in all patients, once airway security is ensured, the standard regional anesthesia technique will be performed by the same person under ultrasound guidance. The ultrasound probe is placed transversely, just above the iliac crest in the midaxillary line. After visualizing the vertebral body, transverse process, psoas major, quadratus lumborum, and erector spinae muscles, a local anesthetic will be administered between the quadratus lumborum and psoas major muscles, using an in-plane approach, as visible on ultrasound. Thirty and 60 minutes after the block, 2 mL of blood will be collected in a routine biochemistry tube, and the blood bupivacaine level will be measured.

Procedure: Quadratus Lumborum Block

Interventions

Transversus Abdominis Plane Block PROCEDURE

transversus abdominis plane block will be performed using 0.25-0.5% cc/kg bupivacaine

GROUP USING Transversus Abdominis Plane Block

Quadratus Lumborum Block PROCEDURE

Quadratus Lumborum Block will be performed using 0.25-0.5% cc/kg bupivacaine

GROUP USING Quadratus Lumborum Block

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients undergoing elective inguinal hernia surgery.
• years of age
• ASA I-II patients

You may not qualify if:

• Vulnerable populations such as those incapacitated, those in intensive care, those unconscious, those unable to give personal consent, or impressionable individuals will not be included in the study.
• Although pediatric patients who may be considered a vulnerable population will be included in the study, patients with serious illnesses such as ASA III-IV will not be included in this group.
• Patients who refuse to participate in the observational study, their parents/legal guardians,
• Patients with incomplete data
• Patients who underwent surgery with an incision other than the planned one for any reason.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Central Study Contacts

Can AKSU, Prof.

CONTACT

05332568290; dr.aksu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: January 25, 2026
• Primary Completion: April 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

TU (1)