Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03443518
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2018-02-06
Brief Title:
Psoas Compartment Block PCB Versus LA Infiltration and Remifentanil Infusion During EVAR
Sponsor:
Dr Erfan and Bagedo General Hospital
Organization:
Dr Erfan and Bagedo General Hospital
Study Overview
Official Title:
Comparative Study Between Psoas Compartment Block PCB Versus Local Anesthesia With Remifentanil Infusion for Endovascular Repair of Abdominal Aortic Aneurysm EVAR A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Endovascular aneurysm repair EVAR was introduced in 1990 for the first time as a minimally invasive procedure instead of the conventional open surgical repair with the aim to decrease morbidity and mortality Nowadays EVAR has become an acceptable management for patients with infra-renal aortic aneurysms AAA A lot of anesthetic techniques have been used successfully for EVAR EVAR requires sedative analgesic medications to achieve an acceptable level of comfort to the patient and cardiorespiratory stability
This is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo EVAR Patients demographic data will be assessed as well as clinical presentation intraoperative complications
30 patients undergoing elective EVAR will be included and will be divided equally into 2 groups
First group is the psoas compartment block PCB 15 patients 30 ml of bupivacaine 025 will be infused over 3 minutes at the anatomical landmark
Second group is the LA and remifentanil group LR 15 patients lidocaine 5 ml of 2 will be injected subcutaneous as local infiltration then remifentanil infusion with rate 003-01 μg kg-1 min-1 to achieve visual analog scale VAS 3 or less
Vital date will be recorded as baseline then every 5 minutes till the end of the procedure VAS will be recorded as baseline then every 5 minutes till the end of the procedure Also stress response which will be measured subjectively as vital data and VAS and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure
This is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo EVAR Patients demographic data will be assessed as well as clinical presentation intraoperative complications
30 patients undergoing elective EVAR will be included and will be divided equally into 2 groups
First group is the psoas compartment block PCB 15 patients 30 ml of bupivacaine 025 will be infused over 3 minutes at the anatomical landmark
Second group is the LA and remifentanil group LR 15 patients lidocaine 5 ml of 2 will be injected subcutaneous as local infiltration then remifentanil infusion with rate 003-01 μg kg-1 min-1 to achieve visual analog scale VAS 3 or less
Vital date will be recorded as baseline then every 5 minutes till the end of the procedure VAS will be recorded as baseline then every 5 minutes till the end of the procedure Also stress response which will be measured subjectively as vital data and VAS and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure
Detailed Description:
Anatomical imaging and clinical studies suggest that psoas compartment block PCB which was done at L2-L3 level has a high possibility to include L1-L2 roots and thus can be suitable for inguinal surgery In our study the investigators introduce a modified PCB which will be performed in lateral decubitus by a 120 mm stimulated needle inserted at the junction between the lateral third and the medial two-thirds of a line drawn at L2-L3 interspace between the interspinous line and a line passing through the posterior superior iliac spine PSIS parallel to the interspinous line If twitching of the anterior thigh area is observed the needle is moved slight cranially When twitching of the inguinal field is observed bupivacaine 05 30 ml will be injected
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?:
False
Is an FDA AA801 Violation?:
None