Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362915
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Analgesic Effect of Illiohypogastic Ilioinguinal Nerve Block in TAVR - TF Prospective Randomized Study
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Analgesic Effect of Illiohypogastic Ilioinguinal Nerve Block in TAVR - TF Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI
Detailed Description:
This prospective randomized double blinded study will take place at cardiothoracic academy Ain Shams University hospitals Cairo Egypt In this study participants care providers and outcomes assessors will be ignorant of the treatment allocation The study will start after obtaining the ethical approval will continue for a 1 year All patients will sign written informed consent before inclusion
Patients fulfilling criteria for TAVI regarding age pathology of aortic valve will be included in the study
Exclusion criteria
Refusal of the patients Patients with neurological disease Disturbed conscious level or psychiatric illness severe respiratory disease need mechanical ventilation or need respiratory support coagulation abnormalities infection at site of injection
After confirming the diagnosis preoperative sizing of the valve by CT heart and then confirmation that no need for TEE guidance of the procedure we will include 60 patients and then will be divided into two groups according to the technique of local anesthesia for the site of puncture
Sample size calculation was done using G power program setting power at 80 and α error at 5 a sample size 52 patients undergoing transcatheter aortic valve implantation TAVI 26 patients receiving iliohypogastric with ilioinguinal nerve block and 26 patients receiving local infiltration with lidocaine will be added to detect a statistically significant difference between the two groups as regard analgesic consumption assuming a large effect size difference dz08regarding Hasak et al2019 Patients will be randomly allocated into two equal groups each one made of 30 patients the allocation ratio is 11 and the method of randomization will be computer generated randomized numbers and it will be hidden in sealed opaque envelopes to conceal the allocation The study will start after acquisition of ethical approval and expected to continue for a year
Group A will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1
Group B will receive ultrasound-guided ilioinguinaliliohypogastric nerve block using 20 ml Bupivicane 025 by an experienced anesthesiologist 9
In both group all patients undergo preoperative assessment Full history examination investigations
ECG ECHO CT heart and CT coronary angiography LL venous arterial duplex CBC Kidney and liver functions Coagulation profile carotid duplex
Inside the catheterization room for both groups after standard monitors and invasive hemodynamic monitors were applied US guided arterial in left radial CVC inserted in left IJV sheath in right IJV for pacemaker
Then Dexmedetomidine started in both groups by 01 up to 05 mickghour without loading with continuous monitoring for the HR and BP
Then the patients divided into two groups group for local infiltration and group for ilioinguinal illiohypogastric nerve block
During injection of local anesthesia in both group any hemodynamic changes blood pressure and heart rate should be closely monitored and recorded during data collection
TAVI procedure will be proceeded All patients were sent to ICU for postoperative care HR MAP Conscious level of the patient assessed every 5 minutes Need for increments narcotics or Propofol recorded and collected at end of procedure
A Study made in 2019 on the effect of illiohypogastric ilioinguinal nerve block in TAVI patient found that Ultrasound-guided II-IH nerve block produce better intraoperative analgesia and less analgesic consumption than local infiltration anesthesia in patients undergoing TAVI
Patients fulfilling criteria for TAVI regarding age pathology of aortic valve will be included in the study
Exclusion criteria
Refusal of the patients Patients with neurological disease Disturbed conscious level or psychiatric illness severe respiratory disease need mechanical ventilation or need respiratory support coagulation abnormalities infection at site of injection
After confirming the diagnosis preoperative sizing of the valve by CT heart and then confirmation that no need for TEE guidance of the procedure we will include 60 patients and then will be divided into two groups according to the technique of local anesthesia for the site of puncture
Sample size calculation was done using G power program setting power at 80 and α error at 5 a sample size 52 patients undergoing transcatheter aortic valve implantation TAVI 26 patients receiving iliohypogastric with ilioinguinal nerve block and 26 patients receiving local infiltration with lidocaine will be added to detect a statistically significant difference between the two groups as regard analgesic consumption assuming a large effect size difference dz08regarding Hasak et al2019 Patients will be randomly allocated into two equal groups each one made of 30 patients the allocation ratio is 11 and the method of randomization will be computer generated randomized numbers and it will be hidden in sealed opaque envelopes to conceal the allocation The study will start after acquisition of ethical approval and expected to continue for a year
Group A will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1
Group B will receive ultrasound-guided ilioinguinaliliohypogastric nerve block using 20 ml Bupivicane 025 by an experienced anesthesiologist 9
In both group all patients undergo preoperative assessment Full history examination investigations
ECG ECHO CT heart and CT coronary angiography LL venous arterial duplex CBC Kidney and liver functions Coagulation profile carotid duplex
Inside the catheterization room for both groups after standard monitors and invasive hemodynamic monitors were applied US guided arterial in left radial CVC inserted in left IJV sheath in right IJV for pacemaker
Then Dexmedetomidine started in both groups by 01 up to 05 mickghour without loading with continuous monitoring for the HR and BP
Then the patients divided into two groups group for local infiltration and group for ilioinguinal illiohypogastric nerve block
During injection of local anesthesia in both group any hemodynamic changes blood pressure and heart rate should be closely monitored and recorded during data collection
TAVI procedure will be proceeded All patients were sent to ICU for postoperative care HR MAP Conscious level of the patient assessed every 5 minutes Need for increments narcotics or Propofol recorded and collected at end of procedure
A Study made in 2019 on the effect of illiohypogastric ilioinguinal nerve block in TAVI patient found that Ultrasound-guided II-IH nerve block produce better intraoperative analgesia and less analgesic consumption than local infiltration anesthesia in patients undergoing TAVI
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