Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07256535

Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location contact

Can Aksu, Prof.

CONTACT

05332568290

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transversus abdominis plane block

Procedure

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

quadratus lumborum block

Procedure

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

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Can AKSU, Prof.

CONTACT

[email protected]

05332568290

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.