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NCT Number: NCT07242196

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

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.

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Key information

Conditions

Postoperative Analgesia Bites and Stings Chemically-Induced Disorders Laparoscopic Abdominal Surgeries Pediatric Surgical Procedures Poisoning Transversalis Fascia Plane Block Transversus Abdominis Plane (TAP) Block Wounds and Injuries

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayça TAŞ TUNA, PROFFESOR

CONTACT

[email protected]

905323004826

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative analgesia

Other

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, will be recorded for each patient.

The primary aim of this assessment is to compare the analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. Duration of analgesia, postoperative VAS scores, and need for rescue analgesics will be documented to determine the relative effectiveness of each block technique.

Primary outcomes

  1. Postoperative Pain Assessment (Visuel Analog Scale)

    Time frame: At 1, 2, 4, 8, 12, and 24 hours after surgery.

    The primary outcome is the comparison of the analgesic efficacy of the transversalis fascia plane block and the transversus abdominis plane block in pediatric laparoscopic surgery, measured using the Visuel Analog Scale (VAS). The Visual Analog Scale is a standardized tool used to quantify the intensity of pain. It consists of a 10-centimeter horizontal line representing a continuous range of pain levels. The minimum score is 0, indicating no pain, and the maximum score is 10, indicating the worst imaginable pain. Higher scores reflect worse outcomes, meaning greater pain intensity. Participants are asked to mark a point on the line that best represents the severity of their pain, and the distance from the zero point is measured in centimeters to obtain the final score.

Secondary outcomes

  1. Duration of Analgesia

    Time frame: 24 hours after surgery

    Time from block administration to the first report of pain Visuel Analog Scale (VAS ≥ 4) or request for rescue analgesia.

  2. Rescue Analgesic Requirement

    Time frame: 24 hours after surgery

    The number and total dose of additional analgesic medications (Intravenosus paracetamol 15 mg/kg as needed for Visual Analog Scale (VAS) ≥ 4) administered within 24 hours postoperatively.

  3. Incidence of Block-Related Complications

    Time frame: 24 hours after surgery

    Any block-related adverse events (e.g., hematoma, infection, local anesthetic toxicity) observed perioperatively or postoperatively.

  4. Patient and Parental Satisfaction

    Time frame: 24 hours after surgery

    Satisfaction with postoperative pain control, assessed using a 5-point Likert scale at 24 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Burçin Medicine Doctor

CONTACT

[email protected]

+905465903851

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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