Blood Bupivacaine ConcentrationNCT07256535
Blood Bupivacaine Concentration After Regional Block Applications in Pediatric Patients
A study testing Transversus Abdominis Plane Block and Quadratus Lumborum Block in people with Blood Bupivacaine Concentration, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Blood Bupivacaine Concentration
- What is being tested?
- Transversus Abdominis Plane Block and Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2026to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing elective inguinal hernia surgery.
- 1-6 years of age
- ASA I-II patients
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli University
Kocaeli
Can Aksu, Prof., 05332568290
About this study
Official title: Blood Bupivacaine Concentration After Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients: A Randomized Controlled 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.
- Conditions
- Blood Bupivacaine Concentration
- Being tested
- Transversus Abdominis Plane Block, Quadratus Lumborum Block
- Keywords
- Pediatric Population, Transversus Abdominis Plan Block, Quadratus Lumborum Block, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane BlockProcedure or surgery
transversus abdominis plane block will be performed using 0.25-0.5% cc/kg bupivacaine
Quadratus Lumborum BlockProcedure or surgery
Quadratus Lumborum Block will be performed using 0.25-0.5% cc/kg bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| GROUP USING Transversus Abdominis Plane Block | Active comparator | 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. Receives: Procedure: Transversus Abdominis Plane Block |
| GROUP USING Quadratus Lumborum Block | Active comparator | 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. Receives: Procedure: Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 and 60 minutes after block application
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).
Measured: 0.HOUR, 1.HOUR, 2.HOUR, 4.HOUR, 6.HOUR, 12.HOUR 24.HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start25 Jan 2026 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Bupivacaine ConcentrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256535
- Sponsor's protocol ID
- KAEK/18.bI.07
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Bupivacaine Concentration After Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07256535
- Acronym / sponsor ID
- KAEK/18.bI.07
- Conditions
- Blood Bupivacaine Concentration
- Keywords
- Pediatric Population, Transversus Abdominis Plan Block, Quadratus Lumborum Block, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP USING Transversus Abdominis Plane Block | Active comparator | Procedure: Transversus Abdominis Plane BlockAfter 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 USING Quadratus Lumborum Block | Active comparator | Procedure: Quadratus Lumborum BlockAfter 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients undergoing elective inguinal hernia surgery.
- 1-6 years of age
- ASA I-II patients
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abdominis Plane Blocktransversus abdominis plane block will be performed using 0.25-0.5% cc/kg bupivacaine | Procedure or surgery | GROUP USING Transversus Abdominis Plane Block |
| Quadratus Lumborum BlockQuadratus Lumborum Block will be performed using 0.25-0.5% cc/kg bupivacaine | Procedure or surgery | GROUP USING Quadratus Lumborum Block |
Primary outcome
Blood bupivacaine level
Time frame: 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)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block and Quadratus Lumborum Block in people with Blood Bupivacaine Concentration, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Can AKSU, Prof. (05332568290, dr.aksu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood bupivacaine level (time frame: 30 and 60 minutes after block application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.