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Regional Anesthesia BlockNCT07256899

Analgesic Comparison of Transversus Fascial Plane and Quadratus Lumborum Blocks in Pediatric Urogenital Procedures

A study testing Anterior Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP / TAP) Block in people with Regional Anesthesia Block and Anesthesia and Analgesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare the analgesic effectiveness of the preoperatively administered Anterior Quadratus Lumborum Block (Anterior QLB) and the Transversalis Fascia Plane Block (TFP block) in children undergoing lower abdominal urogenital surgery. Read more about this study

Who is it for?
Ages 6 months to 12 years
What is being tested?
Anterior Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP / TAP) Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 5 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 6 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 6 months to 12 years
  • Scheduled for lower abdominal urogenital surgery (e.g., inguinal hernia repair, undescended testis surgery)
  • ASA physical status I-III
  • Parental/guardian informed consent obtained

Who cannot join

  • Allergy to local anesthetics
  • Infection at the injection site
  • Coagulopathy or other contraindications to regional anesthesia
  • Laparoscopic orchiopexy scheduled
  • ASA physical status IV
  • Inability to obtain consent from parent/guardian
  • Expected need for postoperative intensive care

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

    Bakırköy, Istanbul, 34153

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Transversus Fascial Plane Block and Anterior Quadratus Lumborum Block for Lower Urogenital Surgery in Pediatric Patients.

This study aims to compare the analgesic effectiveness of the preoperatively administered Anterior Quadratus Lumborum Block (Anterior QLB) and the Transversalis Fascia Plane Block (TFP block) in children undergoing lower abdominal urogenital surgery. The study will include children aged 6 months to 12 years, with randomization performed using the sealed opaque envelope method, and outcome assessment conducted in a double-blinded manner. All patients will receive a standardized anesthesia protocol, and the regional blocks will be performed under ultrasound (US)-guided techniques.

Perioperative evaluations will include pain levels, hemodynamic responses, additional analgesic requirements, block performance time, technical success rate, and family satisfaction. Postoperative pain will be monitored using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and analgesics will be administered when necessary. By comparing these two commonly used regional anesthesia techniques, this study aims to contribute to improved perioperative pain management strategies in the pediatric population.

Read the detailed description

Regional anesthesia techniques have become increasingly preferred in pediatric anesthesia due to their ability to enhance multimodal analgesia, reduce opioid use and associated side effects, and potentially prevent the development of chronic pain (1). With the widespread adoption of ultrasonography (USG), peripheral nerve blocks have gained popularity as safer alternatives to central neuraxial blocks, which carry a higher complication risk. Truncal blocks have become particularly important in abdominal surgeries. Various quadratus lumborum block (QLB) approaches have demonstrated the ability to provide extensive sensory blockade (T4-L2 dermatomes) in cadaveric and clinical studies. However, because the number of randomized controlled trials in this area remains limited, further research is needed to better establish the efficacy of QLB (2).

The anterior quadratus lumborum block (Anterior QLB) provides effective analgesia for procedures such as inguinal hernia repair and orchiopexy, likely due to its potential spread toward the paravertebral space. The transversalis fascia plane (TFP) block provides analgesia by anesthetizing the ilioinguinal and iliohypogastric nerves as they travel along the ventral surface of the quadratus lumborum muscle and course between the transversalis fascia and the transversus abdominis muscle. These nerves originate from the anterior ramus of the L1 spinal nerve, with contributions from T12.

As a primary endpoint, we predict that the TFPB group will have lower FLACC scores in the intraoperative and early and late postoperative periods compared to the anterior QLB group, and consequently, lower opioid and non-opioid drug consumption. As a secondary endpoint, we hypothesize that patient and family satisfaction levels will be higher in the TFPB group during the first 24 hours postoperatively.

Methods:

Children aged 6 months to 12 years scheduled for inguinal hernia repair or orchiopexy will be enrolled. Exclusion criteria include allergy to local anesthetics, infection at the injection site, coagulopathy or other contraindications to regional anesthesia, inability to obtain informed consent, planned laparoscopic orchiopexy, American Society of Anesthesiologists (ASA) physical status class IV, and anticipated postoperative intensive care requirements.

Randomization will be performed using a sealed opaque envelope method, and outcome assessment will be double-blinded. Following premedication, all participants will undergo standard monitoring, including electrocardiography (ECG), peripheral oxygen saturation (SpO₂), and non-invasive blood pressure (NIBP) measurement. Anesthesia induction will be performed with thiopental, fentanyl, and rocuronium, followed by intubation; maintenance anesthesia will be achieved with sevoflurane.

Participants will be allocated into two groups:

Group 1: Anterior Quadratus Lumborum Block (Anterior QLB)

Group 2: Transversalis Fascia Plane Block (TFP block)

All blocks will be performed under sterile conditions using a linear ultrasound transducer and an in-plane technique with appropriately sized (18-22 gauge) intravenous cannulas. All patients will receive 0.4 mL/kg of 0.25% bupivacaine.

Perioperative monitoring will include recording the block-to-incision duration and heart rate (HR) and blood pressure (BP) measurements at baseline and at 5, 10, 20, 30, 45, and 60 minutes after incision. If additional analgesia is required, remifentanil infusion will begin and be titrated in response to hemodynamic changes.

Postoperatively, patients will be monitored for 2 hours in the recovery unit and then transferred to the pediatric surgery ward. Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and patients with a FLACC score of ≥4 will receive acetaminophen and/or tramadol. Families will receive information regarding postoperative pain management, and structured telephone follow-up will be conducted at 24 hours to evaluate family satisfaction, which will be recorded on a 3-point scale (1 = not satisfied, 2 = partially satisfied, 3 = very satisfied).

This study aims to compare the analgesic efficacy of two regional anesthesia techniques widely used in pediatric urogenital surgery and to contribute to the development of safer and more effective perioperative pain management strategies in children.

Being tested
Anterior Quadratus Lumborum Block (QLB), Transversalis Fascia Plane (TFP / TAP) Block
Keywords
anterior QLB, Transversalis Fasia Plane block, Pediatric Regional Analgesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anterior Quadratus Lumborum Block (QLB)Procedure or surgery

    Participants in this group will receive a preoperative ultrasound-guided anterior quadratus lumborum block. The block will be performed under sterile conditions using an in-plane technique with a linear ultrasound probe. The dose of 0.4 ml/kg of 0.25% bupivacaine will be administered according to age and weight. Standardized anesthesia protocols will be applied for all patients. Postoperative pain will be assessed using FLACC scores, and additional analgesics will be administered if required.

  • Transversalis Fascia Plane (TFP / TAP) BlockProcedure or surgery

    Participants in this group will receive a preoperative ultrasound-guided transversalis fascia plane block. The block will be performed supine under sterile conditions using an in-plane technique with a linear ultrasound probe. The dose of 0.4 ml/kg of 0.25% bupivacaine will be administered according to age and weight. Standardized anesthesia protocols will be applied for all patients. Postoperative pain will be assessed using FLACC scores, and additional analgesics will be administered if required.

Study groups in NCT07256899
Study groupRoleWhat they receive
Anterior QLB - Preoperative ultrasound-guided anterior quadratus lumborum blockExperimentalPreoperative ultrasound-guided anterior quadratus lumborum block administered according to standardized anesthesia protocol.
Receives: Procedure: Anterior Quadratus Lumborum Block (QLB)
TFP Block - Preoperative ultrasound-guided transversalis fascia plane blockExperimentalPreoperative ultrasound-guided transversalis fascia plane block administered according to standardized anesthesia protocol.
Receives: Procedure: Transversalis Fascia Plane (TFP / TAP) Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FLACC scores, Total Analgesic Consumption

    the primary outcomes were postoperative FLACC scores at predefined time points and perioperative analgesic consumption, including intraoperative rescue remifentanil and postoperative paracetamol and tramadol during the first 24 hours after surgery.

    Measured: intraoperatif periods and First 24 hours postoperatively

Secondary outcomes (3)
  1. time to first mobilization, FLACC scores at during to mobilization

    Secondary outcomes included time to first mobilization

    Measured: 0-24 hours postoperatively

  2. Time to First Rescue Analgesia, FLACC scores

    Time from the end of surgery to the first additional analgesic administration will be measured and FLACC score at first mobilization

    Measured: 0-24 hours postoperatively

  3. Parent/Patient Satisfaction

    Parents will be contacted by phone to assess satisfaction with pain management using a 3-point Likert scale (1 = not satisfied, 2 = partially satisfied, 3 = very satisfied).

    Measured: 24th postoperative hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion5 Mar 2026
  4. Study completion5 Mar 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel assignment design in which participants are randomly allocated to one of two intervention groups: the Anterior Quadratus Lumborum Block (QLB) group or the Transversalis Fascia Plane (TFP) block group. Each participant receives only one type of block, and there is no crossover between groups.Patients were assigned to two groups on the morning of surgery, prior to intubation: the Anterior Quadratus Lumborum Block (QLB) group or the Transversalis Fascia Plane (TFP) block group, and randomized 1:1. Randomization was achieved using a computer-generated random number sequence; assignment confidentiality was maintained using sequentially numbered, opaque, and sealed envelopes. The randomization process was conducted by an independent investigator who was not involved in patient inclusion, block application, or clinical evaluations. The anesthesiologist who assessed the inclusion and exclusion criteria, monitored intraoperative and postoperative clinical pain scores
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256899
Sponsor's protocol ID
ctf-qlb/tfpb-02
Status last verified
Sep 2026
First submitted
20 Nov 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP / TAP) Block in people with Regional Anesthesia Block and Anesthesia and Analgesia, run by Istanbul University - Cerrahpasa 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Sep 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FLACC scores, Total Analgesic Consumption (time frame: intraoperatif periods and First 24 hours postoperatively). 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 30 Sep 2026.

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