Clinical trial NCT06326944: Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery
Official title: Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fascia Transversalis Plane Block
Keywords: Transversus abdominis plane block
Open inguinal herniorrhaphy
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Time to First need of analgesia
timeFrame: First 6 hours postoperative
Secondary outcomes:
measure: Total Pethidine Consumption
timeFrame: First 6 hours postoperative
measure: Postoperative pain assessment FLACC
timeFrame: First 6 hours postoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University Hospitals
Study officials:
References: