TFPB vs QLB III in Infra-umbilical Pediatric Surgeries

Not Applicable

Not yet recruiting

• Conditions: Surgical Procedure, Unspecified
• Interventions: Other: Quadratus Lumborum Plane Block; Other: Transversalis Fascial Plane Block

• Registration Number: NCT05671484
• Lead Sponsor: Namik Kemal University

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.

Detailed Description

Transversalis fascial plane block and quadratus lumborum block are performed under general anesthesia just before the surgical incision, unless there are contraindications for the procedure for every patient scheduled for elective infraumbilical surgery in our center. In our study, patients will be divided into 2 groups and the effectiveness of trunk plan blocks, which are part of multimodal analgesia, will be compared. In the first group there will be patients who underwent transversalis fascial plane block (TFPB) alone, and in the second group there will be patients who underwent type III quadratus lumborum block (QLB). Post-operative pain scores with the Face, Leg, Activity, Cry, Consolability (FLACC) score will be recorded in 2-6-12-24th hours. Between both groups, postoperative analgesia need, time of analgesia need, presence of nausea and vomiting, surgeon and parent satisfaction will be followed up and recorded. All patients are operated under general anesthesia. General anesthesia is maintained with inhalation anesthesia. At the end of the surgery, the patient is awakened and taken to the recovery unit. In this prospective randomized study, the investigators will compare the efficacy of these two blocks, which are part of multimodal analgesia, with postoperative analgesic consumption. Postoperative patient comfort, complications, demographic findings will be used as data.

Study Timeline

• Study First Submitted: 2022-12-31
• Study First Submitted QC: 2022-12-31
• Study First Posted: 2023-01-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum Block Group	Quadratus Lumborum Plane Block	Patients will receive ultrasound-guided quadratus lumborum block
Transversalis Fascial Plane Block Group	Transversalis Fascial Plane Block	Patients will receive ultrasound-guided transversalis fascial plane block

Primary Outcome Measures

Name	Time	Method
Total dose of paracetamol consumption	in the first 24 hour postoperatively	Total dose of paracetamol consumption in the ward

Secondary Outcome Measures

Name	Time	Method
FLACC score	in the first 24 hour postoperatively	Postoperative FLACC score in the ward. FLACC score is a 10 point behavioral face, leg, activity, cry, consolability pain scale with a minimum score of 0 and a maximum of 10.
Number of postoperative nausea and vomiting	in the first 24 hour postoperatively	Postoperative nausea and vomiting presence
Parental satisfaction level	in the first 24 hour postoperatively	Parental satisfaction level will be evaluated using a five-point Likert scale 5= very satisfied 4= satisfied 3= neutral 2= dissatisfied; 1= very dissatisfied
The 1st time to rescue analgesic need	in the first 24 hour postoperatively	The time to ask for postoperative analgesia is the time from the end of operation to patient reporting FLACC score ≥ 4.

Trial Locations

Locations (1)

Tekirdag Namik Kemal University; 🇹🇷 Tekirdağ, Turkey