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Clinical Trials in Turkey / NCT07256535
Starting soon Not applicable

Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

NCT07256535 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kocaeli University
Phase
Not applicable
Started
2026-01-25
Last updated
2025-12-17

Condition(s) studied

Blood Bupivacaine Concentration

Investigational drug(s) / intervention(s)

Transversus Abdominis Plane BlockQuadratus Lumborum Block

Transversus Abdominis Plane Block: transversus abdominis plane block will be performed using 0.25-0.5% cc/kg bupivacaine

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

Study 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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
6 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Blood bupivacaine level — 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.
  • FLACC (Face, Leg Mobility, Activity, Crying, Consolation) — 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).

Trial sites (1)

FacilityCityRegionStatus
Kocaeli University Kocaeli Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07256535 on ClinicalTrials.gov ↗ ← All trials in Turkey