Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Blood bupivacaine level [Срок оценки: 30 and 60 minutes after block application]
• FLACC (Face, Leg Mobility, Activity, Crying, Consolation) [Срок оценки: 0.HOUR, 1.HOUR, 2.HOUR, 4.HOUR, 6.HOUR, 12.HOUR 24.HOUR]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Kocaeli University — Kocaeli

Идентификаторы

NCT: NCT07256535 · KAEK/18.bI.07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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