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OpenTrials
Completed

NCT Number: NCT06326944

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

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.

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Key information

Conditions

Fascia Transversalis Plane Block

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Hospitals

Giza, Giza Governorate, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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).

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.

Other names: Rescue analgesia

Acetaminophen

Drug

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

Primary outcomes

  1. Time to First need of analgesia

    Time frame: First 6 hours postoperative

    time (minutes) to First need of rescue analgesia

Secondary outcomes

  1. Total Pethidine Consumption

    Time frame: First 6 hours postoperative

    Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.

  2. Postoperative pain assessment FLACC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.