Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorKocaeli University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective inguinal hernia surgery.

1-6 years of age

ASA I-II patients

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transversus Abdominis Plane Block

    Procedure/Surgery

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

  • Quadratus Lumborum Block

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: GROUP USING Transversus Abdominis Plane BlockActive comparator 1 intervention
Group B: GROUP USING Quadratus Lumborum BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood bupivacaine level

After the block application, 2 mL of blood will be taken into a routine biochemistry tube and the blood bupivacaine level will be measured.

Time frame
30 and 60 minutes after block application
2

FLACC (Face, Leg Mobility, Activity, Crying, Consolation)

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).

Time frame
0.HOUR, 1.HOUR, 2.HOUR, 4.HOUR, 6.HOUR, 12.HOUR 24.HOUR

Secondary outcomes

Other outcomes

Sponsors and contacts

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