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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorSakarya University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pediatric patients aged 6 months to 16 years

Classified as ASA physical status I or II

Scheduled to undergo laparoscopic surgery under general anesthesia

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Postoperative analgesia

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Group Transversalis Fascia Plane Block1 intervention
Group B: Group Transversus Abdominis Plane Block1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Duration of Analgesia

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

Time frame
24 hours after surgery
2

Rescue Analgesic Requirement

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.

Time frame
24 hours after surgery
3

Incidence of Block-Related Complications

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

Time frame
24 hours after surgery
4

Patient and Parental Satisfaction

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

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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