Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582667
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Assessing the Effectiveness and Safety of Pericapsular Nerve Group PENG Block in Hip Fracture Patients on Antithrombotic Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Effectiveness and Safety of Pericapsular Nerve Group PENG Block in Hip Fracture Patients on Antithrombotic Therapy A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENG Block
Brief Summary:
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
Detailed Description:
Patients will be randomized into two groups
Group A Antithrombotic Therapy Group 50 Patients on continuous antithrombotic therapy will receive BENG block
Group C Control Group 50 Patients without antithrombotic therapy will receive BENG block
Intervention
PENG Block Standardized administration of the PENG block will be performed by experienced anesthesiologists for both groups using ultrasound device
The patients will be subjected to standard monitoring and received nasal cannula oxygen 2 Lmin Midazolam 1-2 mg will be administered intravenously for light sedation
Under sterile conditions a low-frequency curvilinear probe of ultrasound SonoSite S-Nerve Machine Fujifilm is initially placed in a transverse plane over the anterior inferior iliac spine and is then rotated parallel to the pubic ramus to obtain a short-axis view of the iliopsoas muscle and tendon lying on the ramus pubic adjacent to the iliopubic eminence After skin infiltration with 1-3 mL 1 lidocaine a 23 G 70 mm insulated block needle is inserted in-plane in a lateral-to- medial direction to place the tip in the musculofascial plane between the psoas tendon and the pubic ramus A total of 20 mL 05 bupivacaine AstraZeneca EGYPT is injected slowly in 5 mL increments with intermittent aspiration and under constant ultrasound surveillance for adequate fluid spread Thirty minutes after the block completion standardized endotracheal general anesthesia is induced with propofol 2-25 mgkg fentanyl 05-15 μgkg and atracurium 05 mgkgmaintenance of anesthesia is done with sevoflurane 2-25 with o2and air 6040 Antithrombotic Management Clear protocols for managing antithrombotic therapy in Group A will be implemented considering perioperative bleeding risk
Group A Antithrombotic Therapy Group 50 Patients on continuous antithrombotic therapy will receive BENG block
Group C Control Group 50 Patients without antithrombotic therapy will receive BENG block
Intervention
PENG Block Standardized administration of the PENG block will be performed by experienced anesthesiologists for both groups using ultrasound device
The patients will be subjected to standard monitoring and received nasal cannula oxygen 2 Lmin Midazolam 1-2 mg will be administered intravenously for light sedation
Under sterile conditions a low-frequency curvilinear probe of ultrasound SonoSite S-Nerve Machine Fujifilm is initially placed in a transverse plane over the anterior inferior iliac spine and is then rotated parallel to the pubic ramus to obtain a short-axis view of the iliopsoas muscle and tendon lying on the ramus pubic adjacent to the iliopubic eminence After skin infiltration with 1-3 mL 1 lidocaine a 23 G 70 mm insulated block needle is inserted in-plane in a lateral-to- medial direction to place the tip in the musculofascial plane between the psoas tendon and the pubic ramus A total of 20 mL 05 bupivacaine AstraZeneca EGYPT is injected slowly in 5 mL increments with intermittent aspiration and under constant ultrasound surveillance for adequate fluid spread Thirty minutes after the block completion standardized endotracheal general anesthesia is induced with propofol 2-25 mgkg fentanyl 05-15 μgkg and atracurium 05 mgkgmaintenance of anesthesia is done with sevoflurane 2-25 with o2and air 6040 Antithrombotic Management Clear protocols for managing antithrombotic therapy in Group A will be implemented considering perioperative bleeding risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None