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Recruiting NCT07242196

Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children

Observational Postoperative Analgesia Transversus Abdominis Plane (TAP) Block Transversalis Fascia Plane Block Pediatric Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Postoperative analgesia.
Who it may be relevant to
Registry conditions: Postoperative Analgesia, Transversus Abdominis Plane (TAP) Block, Transversalis Fascia Plane Block, Pediatric Surgical Procedures. Basic parameters: 6 months — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Analgesic Effects of Ultrasound-Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block in Pediatric Laparoscopic Surgery

Overview

This prospective clinical study aims to compare the postoperative analgesic efficacy of the ultrasound-guided transversalis fascia plane block (TFPB) and the transversus abdominis plane (TAP) block in pediatric patients undergoing laparoscopic surgery. Effective and long-lasting postoperative analgesia is essential for patient and parental satisfaction in pediatric anesthesia. With recent advances in ultrasound technology, regional anesthesia techniques have become increasingly utilized in pediatric practice. In the TAP block, local anesthetic is injected between the internal oblique and transversus abdominis muscles, providing analgesia typically between Torachal vertebra 10 (T10) and Lumbar vertebra (L1) dermatomes. The transversalis fascia plane block, developed as a modification of this approach, targets the proximal portions of the T12 and L1 nerves by depositing local anesthetic between the transversus abdominis muscle and the transversalis fascia, potentially offering wider sensory coverage. This study compares both blocks in terms of postoperative pain scores, duration of analgesia, and requirement for rescue analgesics in children undergoing laparoscopic surgery. The results are expected to contribute to the optimization of regional anesthesia techniques and improve pain management strategies in pediatric surgical patients.

Detailed description

In pediatric anesthesia, achieving effective and long-lasting analgesia is essential for ensuring the satisfaction of both pediatric patients and their parents. To guarantee this, many pediatric anesthesiologists have incorporated various regional anesthesia techniques into their daily clinical practice. Advances in technology have enabled the use of many regional anesthesia techniques across diverse clinical settings.

The transversus abdominis plane (TAP) block is an interfascial plane block technique in which a local anesthetic is typically administered, under ultrasound guidance, between the internal oblique and transversus abdominis muscles. Although several approaches have been described for this block, all involve the injection of anesthetic into this interfascial layer, providing analgesia from the T10 to L1 dermatomes. With the widespread adoption of ultrasound technology in pediatric practice, this technique and related fascial plane blocks have become increasingly popular.

The transversalis fascia plane (TFP) block was developed as a technique aiming to block more thoracic nerves. In this approach, local anesthetic is injected between the transversus abdominis muscle and the deep transversalis fascia at the level of the posterior axillary line, targeting the proximal portions of the T12 and L1 nerves. The blockade extends medially toward the inner surface of the quadratus lumborum muscle, thereby providing a more effective block of the anterolateral abdominal wall.

The aim of this study is to compare the postoperative analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. The primary outcome of the study is the evaluation of postoperative pain using validated pediatric pain assessment scales at defined postoperative intervals. The secondary outcomes include the assessment of additional analgesic requirements, the duration of postoperative analgesia provided by each block, and any block-related complications. Furthermore, this research aims to enhance knowledge regarding regional anesthesia applications in pediatric patients and provide scientific contributions to clinical practice.

Interventions

  • Other Postoperative analgesia
    Postoperative analgesia will be assessed using the Visual Analog Scale (VAS) at predefined time points following surgery: 1, 2, 4, 8, 12, and 24 hours postoperatively. Pain evaluation will be performed both at rest and during movement (e.g., coughing or mobilization). Additional analgesics will be administered according to a standardized protocol: intravenous paracetamol (15 mg/kg/dose, every 6 hours as needed) will be given if VAS ≥ 4. Rescue analgesia requirements, including timing and dosage

Primary outcome measures

  • Postoperative Pain Assessment (Visuel Analog Scale) [Time frame: At 1, 2, 4, 8, 12, and 24 hours after surgery.]
Secondary outcome measures (4)
  • Duration of Analgesia [Time frame: 24 hours after surgery]
  • Rescue Analgesic Requirement [Time frame: 24 hours after surgery]
  • Incidence of Block-Related Complications [Time frame: 24 hours after surgery]
  • Patient and Parental Satisfaction [Time frame: 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • Pediatric patients aged 6 months to 16 years
  • Classified as ASA physical status I or II
  • Scheduled to undergo laparoscopic surgery under general anesthesia

Exclusion criteria

  • Patients classified as ASA physical status III or IV
  • Known allergy or hypersensitivity to local anesthetic agents
  • Presence of bleeding diathesis or coagulation disorders
  • Infection at the injection site or local skin lesions preventing block application

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Sakarya University-Anesthesiology and Reanimation Department — Sakarya

Publications

  • Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x. PMID 20964768

Identifiers

NCT: NCT07242196 · E-43012747-050.04-513206-484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗