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

NCT07242196 | Recruiting

• 1 other identifier: E-43012747-050.04-513206-484
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Analgesia; Transversus Abdominis Plane (TAP) Block; Transversalis Fascia Plane Block; Pediatric Surgical Procedures; Laparoscopic Abdominal Surgeries

Keywords

transversus abdominis plane block; transversalis fascia plane block; pediatrics; laparoscopic abdominal surgery; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Assessment (Visuel Analog Scale)

  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.

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

Secondary Outcomes (4)

• Duration of Analgesia

  24 hours after surgery

• Rescue Analgesic Requirement

  24 hours after surgery

• Incidence of Block-Related Complications

  24 hours after surgery

• Patient and Parental Satisfaction

  24 hours after surgery

Study Arms (2)

Group Transversalis Fascia Plane Block

Patients in this group will receive an ultrasound-guided transversalis fascia plane block prior to surgery. The local anesthetic will be 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. This technique aims to provide effective analgesia for the anterolateral abdominal wall and to extend sensory blockade coverage compared to traditional Transversus Abdominis Plane block. Postoperative pain, additional analgesic requirements, and duration of analgesia will be monitored and recorded.

Other: Postoperative analgesia

Group Transversus Abdominis Plane Block

Patients in this group will receive an ultrasound-guided transversus abdominis plane (TAP) block prior to surgery. The local anesthetic will be administered between the internal oblique and transversus abdominis muscles, typically providing analgesia in the T10-L1 dermatomes. This group will serve as a comparative control to assess the relative efficacy of the TAP block versus the transversalis fascia plane block in managing postoperative pain. Postoperative Visual Analog Scale scores, need for rescue analgesics, and duration of analgesia will be recorded.

Other: Postoperative analgesia

Interventions

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.

Group Transversalis Fascia Plane Block; Group Transversus Abdominis Plane Block

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pediatric patients aged 6 months to 16 years who are scheduled to undergo elective laparoscopic surgery under general anesthesia. All participants will be classified as ASA physical status I or II according to the American Society of Anesthesiologists classification. Patients with ASA III-IV status, known allergy to local anesthetic agents, bleeding diathesis or coagulation disorders, and infection at the injection site will be excluded. Eligible patients of both sexes will be enrolled, and healthy volunteers will not be included. Participants will be randomly assigned to receive either an ultrasound-guided transversalis fascia plane block or a transversus abdominis plane block for postoperative analgesia. The study aims to represent the typical pediatric population undergoing minimally invasive abdominal surgery under general anesthesia.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Serdivan, 54050, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Burçin Medicine Doctor

CONTACT

+905465903851; burcin.ersoy90@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: December 18, 2025
• Primary Completion: March 9, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-10

Locations

TU (1)