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

NCT06326944 | Recruiting Phase 2

• 1 other identifier: MS-527-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fascia Transversalis Plane Block

Keywords

Transversus abdominis plane block; Open inguinal herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• Time to First need of analgesia

  time (minutes) to First need of rescue analgesia

  First 6 hours postoperative

Secondary Outcomes (2)

• Total Pethidine Consumption

  First 6 hours postoperative

• Postoperative pain assessment FLACC

  First 6 hours postoperative

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will receive fascia transversalis block

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

Group B

ACTIVE COMPARATOR

Patients will receive Transversus abdominus plane block

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

Interventions

Ultrasound- guided Fascia Transversalis plane block 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

Group A

Ultrasound-guided Transversus abdominus plane block 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.

Group B

Fentanyl 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).

Group A; Group B

Pethidine 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.

Also known as: Rescue analgesia

Group A; Group B

Acetaminophen DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I-II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospitals

Giza, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl; Meperidine; Acetaminophen

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ramy m alkonaiesy, MD

CONTACT

01224883990; ramyalkonaiesy@gmail.com

Nada H kotb, MBBCh

CONTACT

01007980265; nada.h.kotb@students.kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: January 18, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

EG (1)