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Not yet recruiting NCT07256535

Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

No phase Interventional Blood Bupivacaine Concentration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transversus Abdominis Plane Block, Quadratus Lumborum Block.
Who it may be relevant to
Registry conditions: Blood Bupivacaine Concentration. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Blood bupivacaine level [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Kocaeli University — Kocaeli

Identifiers

NCT: NCT07256535 · KAEK/18.bI.07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗