Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery

Phase 2

Recruiting

• Conditions: Fascia Transversalis Plane Block
• Interventions: Procedure: Ultrasound-guided Transversus abdominus plane block; Procedure: Ultrasound- guided Fascia Transversalis plane block; Drug: Fentanyl; Drug: Pethidine; Drug: Acetaminophen

• Registration Number: NCT06326944
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.

Detailed Description

All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time Intra-operative management Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.

General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. Volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.

The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX/13-6 MHZ transducer will be used. 0.4 ml/kg bupivacaine 0.25% will be installed in the block plane. After receiving the block, surgical incision will be allowed to be done after 15 minutes.

Continuous recording of heart rate, blood pressure, will be carried out from the moment of injection at timely intervals intra-operative.

Increase of HR BP. \>30% of baseline Indicates failure of block so fentanyl will be given at 1 mic / kg intra-operative.

Postoperative pain assessment using FLACC score will then follow till 6 hours

Study Timeline

• Study Start: 2024-01-18
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ASA physical status I-II

Exclusion Criteria

• Parents' refusal to participate in the study.
• Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
• Localized infection at the site of needle insertion.
• Known hypersensitivity or allergies to any of the used drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Acetaminophen	Patients will receive fascia transversalis block
Group A	Fentanyl	Patients will receive fascia transversalis block
Group B	Ultrasound-guided Transversus abdominus plane block	Patients will receive Transversus abdominus plane block
Group A	Ultrasound- guided Fascia Transversalis plane block	Patients will receive fascia transversalis block
Group B	Fentanyl	Patients will receive Transversus abdominus plane block
Group A	Pethidine	Patients will receive fascia transversalis block
Group B	Acetaminophen	Patients will receive Transversus abdominus plane block
Group B	Pethidine	Patients will receive Transversus abdominus plane block

Primary Outcome Measures

Name	Time	Method
Time to First need of analgesia	First 6 hours postoperative	time (minutes) to First need of rescue analgesia

Secondary Outcome Measures

Name	Time	Method
Total Pethidine Consumption	First 6 hours postoperative	Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.
Postoperative pain assessment FLACC	First 6 hours postoperative	In the PACU, quality of analgesia was assessed every 15 minutes for the first hour then at 2,4 ,and 6 hours postoperative using (face, legs, activity, and cry consolability scale) (FLACC) pain score

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Giza, Egypt