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

Kasr El Aini Hospital

Status and phase: Enrolling; Phase 2

Conditions: Fascia Transversalis Plane Block

Treatments: Procedure: Ultrasound-guided Transversus abdominus plane block; Drug: Acetaminophen; Procedure: Ultrasound- guided Fascia Transversalis plane block; Drug: Fentanyl; Drug: Pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06326944

MS-527-2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

Patients will receive fascia transversalis block

Treatment:

Procedure: Ultrasound- guided Fascia Transversalis plane block

Drug: Pethidine

Drug: Acetaminophen

Drug: Fentanyl

Group B

Active Comparator group

Description:

Patients will receive Transversus abdominus plane block

Treatment:

Drug: Pethidine

Drug: Acetaminophen

Procedure: Ultrasound-guided Transversus abdominus plane block

Drug: Fentanyl