TFPB vs QLB III in Infra-umbilical Pediatric Surgeries

NCT ID: NCT05671484

Last Updated: 2026-02-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Transversalis Fascial Plane Block Group

Patients will receive ultrasound-guided transversalis fascial plane block

Group Type ACTIVE_COMPARATOR

Transversalis Fascial Plane Block

Intervention Type OTHER

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 Block Group

Patients will receive ultrasound-guided quadratus lumborum block

Group Type ACTIVE_COMPARATOR

Quadratus Lumborum Plane Block

Intervention Type OTHER

Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction

Interventions

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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

Intervention Type OTHER

Quadratus Lumborum Plane Block

Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction

Intervention Type OTHER

Other Intervention Names

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TFPB QLB III

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Namik Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Onur Baran

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur Baran, Asst. Prof.

Role: STUDY_CHAIR

Namik Kemal University

Ayhan Şahin, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Cavidan Arar, Prof.

Role: STUDY_DIRECTOR

Namik Kemal University

Locations

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Tekirdag Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33307633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36288584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30886131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30658324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25642956 (View on PubMed)

Other Identifiers

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2022.205.11.06

Identifier Type: -

Identifier Source: org_study_id

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