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

Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Fascia Transversalis Plane Block
• Intervention / Treatment: Drug: Fentanyl; Procedure: Ultrasound- guided Fascia Transversalis plane block; Drug: Pethidine; Drug: Acetaminophen; Procedure: Ultrasound-guided Transversus abdominus 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ramy m alkonaiesy, MD; Phone Number: 01224883990; Email: ramyalkonaiesy@gmail.com
• Study Contact Backup: Name: Nada H kotb, MBBCh; Phone Number: +2 01007980265; Email: nada.h.kotb@students.kasralainy.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 11562
    • Recruiting
    • Cairo University Hospitals
    • Contact: Maher a Fawzy, MD; Phone Number: 01201730249; Email: kasralainirec@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients will receive fascia transversalis block	Drug: Fentanyl; patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).; Procedure: Ultrasound- guided Fascia Transversalis plane block; Ultrasound probe will be placed in a transverse orientation above the iliac crest; and the external oblique, internal oblique (IO), and transversus abdominis TA muscles will be identified and traced posteriorly until first the TA muscle and then the IO muscle tapered into their common aponeurosis, adjacent to the quadratus lumborum muscle. The tip of a 22-gauge 80-mm block needle will be positioned just deep to the TA muscle and its aponeurosis at the point where the TA is tapered off. 0.4 ml/kg bupivacaine 0.25% will be injected into the plane between the TA and underlying transversalis fascia; Drug: Pethidine; Pethidine IV will be given as rescue analgesia (0.5 mg/kg) if the FLACC pain score was more than 4 , the maximum allowed dose is 1mg/kg every 4 hours.; Other Names: Rescue analgesia; Drug: Acetaminophen; patients will be given paracetamol (15 mg /kg/8 hrs ).
Active Comparator: Group B; Patients will receive Transversus abdominus plane block	Drug: Fentanyl; patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).; Drug: Pethidine; Pethidine IV will be given as rescue analgesia (0.5 mg/kg) if the FLACC pain score was more than 4 , the maximum allowed dose is 1mg/kg every 4 hours.; Other Names: Rescue analgesia; Drug: Acetaminophen; patients will be given paracetamol (15 mg /kg/8 hrs ).; Procedure: Ultrasound-guided Transversus abdominus plane block; the probe will be placed transversely in the mid-axillary line between the iliac crest and the costal margin at the level of the umbilicus. The external oblique, internal oblique and transversus abdominis muscles and their fascias will be visualized. A 22 gauge, 80 mm needle will be introduced anteriorly and in the plane of the ultrasound probe, and on entering the plane between IO and TA, 2 ml of 0.9% saline will be injected to verify the correct position of the needle. Following negative aspiration, 0.4 ml/kg of bupivacaine 0.25% will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First need of analgesia	time (minutes) to First need of rescue analgesia	First 6 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Pethidine Consumption	Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.	First 6 hours postoperative
Postoperative pain assessment FLACC	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	First 6 hours postoperative

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Transversus abdominis plane block; Open inguinal herniorrhaphy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Acetaminophen; Meperidine
• Other Study ID Numbers: MS-527-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No