Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

December 9, 2025 updated by: Can AKSU, Kocaeli University

Blood Bupivacaine Concentration After Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli University
        • Contact:
          • Can Aksu, Prof.
          • Phone Number: 05332568290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing elective inguinal hernia surgery.
  • 1-6 years of age
  • ASA I-II patients

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP USING Transversus Abdominis Plane Block
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
transversus abdominis plane block will be performed using 0.25-0.5% cc/kg bupivacaine
Active Comparator: GROUP USING Quadratus Lumborum Block
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
Quadratus Lumborum Block will be performed using 0.25-0.5% cc/kg bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood bupivacaine level
Time Frame: 30 and 60 minutes after block application
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)
Time Frame: 0.HOUR, 1.HOUR, 2.HOUR, 4.HOUR, 6.HOUR, 12.HOUR 24.HOUR
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

April 25, 2026

Study Completion (Estimated)

June 25, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAEK/18.bI.07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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