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

NCT ID: NCT06326944

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-05-31

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

Conditions

Fascia Transversalis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A

Patients will receive fascia transversalis block

Group Type: ACTIVE_COMPARATOR

Ultrasound- guided Fascia Transversalis plane block

Intervention Type: PROCEDURE

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

Fentanyl

Intervention Type: DRUG

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).

Pethidine

Intervention Type: DRUG

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.

Acetaminophen

Intervention Type: DRUG

patients will be given paracetamol (15 mg /kg/8 hrs ).

Group B

Patients will receive Transversus abdominus plane block

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided Transversus abdominus plane block

Intervention Type: PROCEDURE

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.

Fentanyl

Intervention Type: DRUG

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).

Pethidine

Intervention Type: DRUG

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.

Acetaminophen

Intervention Type: DRUG

patients will be given paracetamol (15 mg /kg/8 hrs ).

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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).

Intervention Type: 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.

Intervention Type: DRUG

Acetaminophen

patients will be given paracetamol (15 mg /kg/8 hrs ).

Intervention Type: DRUG

Other Intervention Names

Rescue analgesia

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

maged gamal

Anesthesia lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ramy m alkonaiesy, MD

Role: CONTACT

ramyalkonaiesy@gmail.com

01224883990

Nada H kotb, MBBCh

Role: CONTACT

nada.h.kotb@students.kasralainy.edu.eg

01007980265 ext. +2

Facility Contacts

Maher a Fawzy, MD

Role: primary

kasralainirec@kasralainy.edu.eg

01201730249

Other Identifiers

MS-527-2023

Identifier Type: -

Identifier Source: org_study_id