Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326944
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-18
Brief Title:
Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery A Randomized Comparative Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 002 mgKg and midazolam 02 mgKg will be followed by insertion of intravenous IV 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 05mgkg and fentanyl 1μgkg patients will be given Endotracheal intubation will then follow by appropriate size of endotracheal tube Volume control ventilation VCV 5-7 mlkg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using GE-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 01mgkg will be given every 30 minutes for neuromuscular blockade
The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX13-6 MHZ transducer will be used 04 mlkg bupivacaine 025 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
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 05mgkg and fentanyl 1μgkg patients will be given Endotracheal intubation will then follow by appropriate size of endotracheal tube Volume control ventilation VCV 5-7 mlkg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using GE-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 01mgkg will be given every 30 minutes for neuromuscular blockade
The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX13-6 MHZ transducer will be used 04 mlkg bupivacaine 025 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None