TFPB vs QLB III in Infra-umbilical Pediatric Surgeries

NCT05671484 | Completed

• 1 other identifier: 2022.205.11.06
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgical Procedure, Unspecified

Keywords

Transversalis Fascial Plane Block; Quadratus Lumborum Block; Analgesia; Pediatric; Ultrasound Guidance

Outcome Measures

Primary Outcomes (1)

• Total dose of paracetamol consumption

  Total dose of paracetamol consumption in the ward

  in the first 24 hour postoperatively

Secondary Outcomes (4)

• FLACC score

  in the first 24 hour postoperatively

• The 1st time to rescue analgesic need

  in the first 24 hour postoperatively

• Number of postoperative nausea and vomiting

  in the first 24 hour postoperatively

• Parental satisfaction level

  in the first 24 hour postoperatively

Study Arms (2)

Transversalis Fascial Plane Block Group

ACTIVE COMPARATOR

Patients will receive ultrasound-guided transversalis fascial plane block

Other: Transversalis Fascial Plane Block

Quadratus Lumborum Block Group

ACTIVE COMPARATOR

Patients will receive ultrasound-guided quadratus lumborum block

Other: Quadratus Lumborum Plane Block

Interventions

Transversalis Fascial Plane Block OTHER

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

Also known as: TFPB

Transversalis Fascial Plane Block Group

Quadratus Lumborum Plane Block OTHER

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

Also known as: QLB III

Quadratus Lumborum Block Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 33307633 BACKGROUND

• 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.

  PMID: 36288584 BACKGROUND

• 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.

  PMID: 30886131 BACKGROUND

• 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.

  PMID: 30658324 BACKGROUND

• 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.

  PMID: 25642956 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Onur Baran, Asst. Prof.

  Namik Kemal University

  STUDY CHAIR

• Ayhan Şahin, Asst. Prof.

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

• Cavidan Arar, Prof.

  Namik Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patients will be divided randomly by a computer-generated randomization table into two equal groups.

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 4, 2023
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)