- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05671484
TFPB vs QLB III in Infra-umbilical Pediatric Surgeries
February 6, 2026 updated by: Onur Baran, Namik Kemal University
Investigation of the Effects of Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block Applied in Pediatric Infra-umbilical Surgeries on Postoperative Pain and Analgesic Consumption
Regional anesthetic techniques; they reduce postoperative morbidity, provide early mobilization and provide great advantages by significantly reducing the need for narcotic analgesics.
Regional anesthetic techniques are widely used in our clinic for postoperative analgesia, especially in infants and children.
In patients undergoing lower abdominal surgery, postoperative analgesia is usually provided by systemic opioids and neuraxial methods.
Complications such as sedation, respiratory depression, itching, nausea, vomiting and possible paraplegia or bleeding of neuraxial methods due to the use of opioids seem to be the biggest disadvantages of these two methods.
Transversalis fascial plane (TFP) block is a regional anesthesia technique that provides intraoperative and postoperative analgesia as an alternative to caudal and epidural analgesia, especially in children.
Transversalis fascial plane (TFP) block was first described in 2009.
TFP block has been shown to be effective as an alternative to epidural analgesia and as part of a multimodal postoperative analgesic approach in lower abdominal and pelvic surgeries in children.
Quadratus lumborum block (QLB) is a widely used regional anesthesia technique.
It is used in pediatric patients to reduce postoperative pain in supraumbilical or infraumbilical surgeries.
As a common result of all approaches, the main effect in quadratus lumborum block is anesthesia of the lateral cutaneous branches.
In our center, the investigators have been using both methods, alone or in combination, routinely for a long time, and the investigators aim to compare the two methods in this study.
This study consists of comparing two domain blocks known as part of multimodal analgesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Transversalis fascial plane block and quadratus lumborum block are performed under general anesthesia just before the surgical incision, unless there are contraindications for the procedure for every patient scheduled for elective infraumbilical surgery in our center.
In our study, patients will be divided into 2 groups and the effectiveness of trunk plan blocks, which are part of multimodal analgesia, will be compared.
In the first group there will be patients who underwent transversalis fascial plane block (TFPB) alone, and in the second group there will be patients who underwent type III quadratus lumborum block (QLB).
Post-operative pain scores with the Face, Leg, Activity, Cry, Consolability (FLACC) score will be recorded in 2-6-12-24th hours.
Between both groups, postoperative analgesia need, time of analgesia need, presence of nausea and vomiting, surgeon and parent satisfaction will be followed up and recorded.
All patients are operated under general anesthesia.
General anesthesia is maintained with inhalation anesthesia.
At the end of the surgery, the patient is awakened and taken to the recovery unit.
In this prospective randomized study, the investigators will compare the efficacy of these two blocks, which are part of multimodal analgesia, with postoperative analgesic consumption.
Postoperative patient comfort, complications, demographic findings will be used as data.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tekirdağ, Turkey (Türkiye)
- Tekirdag Namik Kemal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 7 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Parental acceptation to participate and signed written consent
- Aged between 3 and 7
- American Society of Anesthesiologists (ASA) physical score I or II
- Elective infra umbilical surgery
Exclusion Criteria:
- Parental refusal to participate
- Known allergy to local anesthetics
- American Society of Anesthesiologists (ASA) physical score ≥ III
- Coagulopathy
- Hypersensitivity history to the agents to be used
- Local infections
- Known anatomically or systemic disorder
- Known growth and developmental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Transversalis Fascial Plane Block Group
Patients will receive ultrasound-guided transversalis fascial plane block
|
Patients will receive ultrasound-guided transversalis fascial plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
Other Names:
|
|
Active Comparator: Quadratus Lumborum Block Group
Patients will receive ultrasound-guided quadratus lumborum block
|
Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total dose of paracetamol consumption
Time Frame: in the first 24 hour postoperatively
|
Total dose of paracetamol consumption in the ward
|
in the first 24 hour postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FLACC score
Time Frame: in the first 24 hour postoperatively
|
Postoperative FLACC score in the ward.
FLACC score is a 10 point behavioral face, leg, activity, cry, consolability pain scale with a minimum score of 0 and a maximum of 10.
|
in the first 24 hour postoperatively
|
|
The 1st time to rescue analgesic need
Time Frame: in the first 24 hour postoperatively
|
The time to ask for postoperative analgesia is the time from the end of operation to patient reporting FLACC score ≥ 4.
|
in the first 24 hour postoperatively
|
|
Parental satisfaction level
Time Frame: in the first 24 hour postoperatively
|
Parental satisfaction level will be evaluated using a five-point Likert scale 5= very satisfied 4= satisfied 3= neutral 2= dissatisfied 1= very dissatisfied |
in the first 24 hour postoperatively
|
|
Number of postoperative nausea and vomiting
Time Frame: in the first 24 hour postoperatively
|
Postoperative nausea and vomiting presence
|
in the first 24 hour postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Onur Baran, Asst. Prof., Namik Kemal University
- Principal Investigator: Ayhan Şahin, Asst. Prof., Namik Kemal University
- Study Director: Cavidan Arar, Prof., Namik Kemal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ahiskalioglu A, Aydin ME, Doymus O, Yayik AM, Celik EC. Ultrasound guided transversalis fascia plane block for lower abdominal surgery: First pediatric report. J Clin Anesth. 2019 Aug;55:130-131. doi: 10.1016/j.jclinane.2018.12.046. Epub 2019 Jan 15. No abstract available.
- Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
- Abdelbaser I, Mageed NA, El-Emam EM, ALseoudy MM, Elmorsy MM. Preemptive analgesic efficacy of ultrasound-guided transversalis fascia plane block in children undergoing inguinal herniorrhaphy: a randomized, double-blind, controlled study. Korean J Anesthesiol. 2021 Aug;74(4):325-332. doi: 10.4097/kja.20601. Epub 2020 Dec 14.
- Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
- Black ND, Malhas L, Jin R, Bhatia A, Chan VWS, Chin KJ. The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial. Korean J Anesthesiol. 2019 Aug;72(4):336-343. doi: 10.4097/kja.d.18.00352. Epub 2019 Mar 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
February 1, 2026
Study Completion (Actual)
February 1, 2026
Study Registration Dates
First Submitted
December 31, 2022
First Submitted That Met QC Criteria
December 31, 2022
First Posted (Actual)
January 4, 2023
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022.205.11.06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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