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Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients

NCT ID: NCT07256535

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-25

Study Completion Date

2026-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Bupivacaine Concentration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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GROUP USING Transversus Abdominis Plane Block

After induction of general anesthesia in all patients, once airway security is ensured, the standard regional anesthesia technique will be performed under ultrasound guidance by the same physician. A transversus abdominis plane block will be performed using an in-plane approach, passing through the external oblique and internal oblique muscles visible on ultrasound, and then advancing toward the fascial layer separating the internal oblique and transversus abdominis muscles. Following the block, the surgical team will begin the procedure. Thirty and sixty minutes after the block, 2 mL of blood will be collected into a routine biochemistry tube, and the blood bupivacaine level will be measured.

Group Type ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type PROCEDURE

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

GROUP USING Quadratus Lumborum Block

After induction of general anesthesia in all patients, once airway security is ensured, the standard regional anesthesia technique will be performed by the same person under ultrasound guidance. The ultrasound probe is placed transversely, just above the iliac crest in the midaxillary line. After visualizing the vertebral body, transverse process, psoas major, quadratus lumborum, and erector spinae muscles, a local anesthetic will be administered between the quadratus lumborum and psoas major muscles, using an in-plane approach, as visible on ultrasound. Thirty and 60 minutes after the block, 2 mL of blood will be collected in a routine biochemistry tube, and the blood bupivacaine level will be measured.

Group Type ACTIVE_COMPARATOR

Quadratus Lumborum Block

Intervention Type PROCEDURE

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

Interventions

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Transversus Abdominis Plane Block

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

Intervention Type PROCEDURE

Quadratus Lumborum Block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Can AKSU

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Can AKSU, Prof.

Role: CONTACT

[email protected]
05332568290

Facility Contacts

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Can Aksu, Prof.

Role: primary

05332568290

Other Identifiers

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KAEK/18.bI.07

Identifier Type: -

Identifier Source: org_study_id