Surgical Procedure, UnspecifiedNCT05671484
TFPB vs QLB III in Infra-umbilical Pediatric Surgeries
A study testing Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block in people with Surgical Procedure, Unspecified, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Feb 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Transversalis Fascial Plane Block, Quadratus Lumborum Plane Block
- Keywords
- Transversalis Fascial Plane Block, Quadratus Lumborum Block, Analgesia, Pediatric, Ultrasound Guidance
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascial Plane BlockOther
Also called TFPB
Patients will receive ultrasound-guided transversalis fascial plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
Quadratus Lumborum Plane BlockOther
Also called QLB III
Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascial Plane Block Group | Active comparator | Patients will receive ultrasound-guided transversalis fascial plane block Receives: Other: Transversalis Fascial Plane Block |
| Quadratus Lumborum Block Group | Active comparator | Patients will receive ultrasound-guided quadratus lumborum block Receives: Other: Quadratus Lumborum Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of paracetamol consumption
Total dose of paracetamol consumption in the ward
Measured: in the first 24 hour postoperatively
Secondary outcomes (4)
FLACC score
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.
Measured: in the first 24 hour postoperatively
The 1st time to rescue analgesic need
The time to ask for postoperative analgesia is the time from the end of operation to patient reporting FLACC score ≥ 4.
Measured: in the first 24 hour postoperatively
Number of postoperative nausea and vomiting
Postoperative nausea and vomiting presence
Measured: in the first 24 hour postoperatively
Parental satisfaction level
Parental satisfaction level will be evaluated using a five-point Likert scale 5= very satisfied 4= satisfied 3= neutral 2= dissatisfied
1= very dissatisfied
Measured: in the first 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Sep 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Baran, Namik Kemal University
- Investigators
- Onur Baran, Asst. Prof., Study chair, Namik Kemal UniversityAyhan Şahin, Asst. Prof., Principal investigator, Namik Kemal UniversityCavidan Arar, Prof., Study director, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671484
- Sponsor's protocol ID
- 2022.205.11.06
- Status last verified
- Feb 2026
- First submitted
- 31 Dec 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33307633Arafa 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.
PubMed 36288584Black 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.
PubMed 30886131Ahiskalioglu 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.
PubMed 30658324Chakraborty 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.
PubMed 25642956
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05671484
- Acronym / sponsor ID
- 2022.205.11.06
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Transversalis Fascial Plane Block, Quadratus Lumborum Block, Analgesia, Pediatric, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 4 Jan 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups.
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascial Plane Block Group | Active comparator | Other: Transversalis Fascial Plane BlockPatients will receive ultrasound-guided transversalis fascial plane block |
| Quadratus Lumborum Block Group | Active comparator | Other: Quadratus Lumborum Plane BlockPatients will receive ultrasound-guided quadratus lumborum block |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Transversalis Fascial Plane BlockAlso: TFPBPatients will receive ultrasound-guided transversalis fascial plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction | Other | Transversalis Fascial Plane Block Group |
| Quadratus Lumborum Plane BlockAlso: QLB IIIPatients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction | Other | Quadratus Lumborum Block Group |
Primary outcome
Total dose of paracetamol consumption
Time frame: in the first 24 hour postoperatively
Total dose of paracetamol consumption in the ward
4 secondary outcomes
FLACC score
Time frame: in the first 24 hour postoperatively
The 1st time to rescue analgesic need
Time frame: in the first 24 hour postoperatively
Number of postoperative nausea and vomiting
Time frame: in the first 24 hour postoperatively
Parental satisfaction level
Time frame: in the first 24 hour postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 33307633Abdelbaser 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.
- Background: PubMed 36288584Arafa 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.
- Background: PubMed 30886131Black 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.
- Background: PubMed 30658324Ahiskalioglu 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.
- Background: PubMed 25642956Chakraborty 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Onur Baran, Asst. Prof. study chair
Namik Kemal University
Ayhan Şahin, Asst. Prof. principal investigator
Namik Kemal University
Cavidan Arar, Prof. study director
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block in people with Surgical Procedure, Unspecified, run by Namik Kemal 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 4 inclusion and 8 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 10 Feb 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?
Total dose of paracetamol consumption (time frame: in the first 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671484, which also lists 5 linked publications.
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 10 Feb 2026.