Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449599
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-27
Brief Title:
Rhomboid Intercostal Block in Cardioverter Defibrillator Implantation ICD
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Efficiency of Ultrasound-Guided Rhomboid Intercostal Block for Cardioverter Defibrillator Implantation ICD A Prospective Randomized-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ICD implantation can be painful procedure even under local anesthesia and sedation In this prospective-randomised study ultrasound-guided rhomboid intercostal block will be performed to reduce intraoperative and postoperative pain Also comfort of patients and the cardiologists will be evaluated In this way we expect to reduce possible complications and make this procedure more comfortable for patients and clinicians
Detailed Description:
ICD implantation is mostly performed under local anesthesiaLAWith sedationthe patients anxiety and pain decrease but complications such as respiratory depression and hemodynamic deterioration may occur due to sedation
Rhomboid intercostal blockRIB is often applied between the rhomboid major and the intercostal muscle from the midpoint of the medial edge of the scapulaWith RIBcutaneous branches of the thoracic intercostal nerves between T2-T8 are targetedNo studies have been found on the analgesic efficiency of RIB in ICD implantation
Standard procedure will be applied to the control groupC n25In RIB groupRIBBn25 LA and RIBB will be performed under USG guidance
Patients demographic datathe vessel used to advance ICD leadthe side where the ICD is placedICD battery locationsubcutaneoussubfascialsubpectoralprocedure duration complications seen during the procedureneed for additional analgesics will be recordedThe highest pain level felt during implantation and pain level felt with coughing and at rest at the 3rd 6th 12th and 24th postoperative hours will be recorded according to the Numeric Rating Scale-11NRS -11 scoring systemFor patientphysician satisfaction5-point Likert scale will be used In the follow-up of RIBB patients if the patient expresses pain or NRS4 1 g acetaminophen will be administered intravenously
In the control grouppatients will be administered LA using standard methodsIf necessaryin postoperative period 1 g Acetominophen will be given intravenously every 8 hours
Pain occurs especially during venous puncture surgical incisionopening a pocket for the ICD battery and battery insertionAlthough LA is often applied to cover the superficial tissue puncture areas and pocket areas before the procedure it may be insufficient to completely eliminate painPatients experience instability in intraoperative and postoperative hemodynamics due to painInstable hemodynamics in cardiac patients increases the frequency of undesirable cardiac eventsWith increasing painpatients move during the operationthe procedure time is prolonged and complications such as bleedingunwanted vascular injury surgical incisions and electrode malposition increaseThe first aim of the study is to investigate the efficiency of RIBwhich is practical to apply with USG and has low complicationsin ICD patientsSecondary aim is to investigate patient and physician satisfaction in ICD implantation cases where RIB will be applied
Rhomboid intercostal blockRIB is often applied between the rhomboid major and the intercostal muscle from the midpoint of the medial edge of the scapulaWith RIBcutaneous branches of the thoracic intercostal nerves between T2-T8 are targetedNo studies have been found on the analgesic efficiency of RIB in ICD implantation
Standard procedure will be applied to the control groupC n25In RIB groupRIBBn25 LA and RIBB will be performed under USG guidance
Patients demographic datathe vessel used to advance ICD leadthe side where the ICD is placedICD battery locationsubcutaneoussubfascialsubpectoralprocedure duration complications seen during the procedureneed for additional analgesics will be recordedThe highest pain level felt during implantation and pain level felt with coughing and at rest at the 3rd 6th 12th and 24th postoperative hours will be recorded according to the Numeric Rating Scale-11NRS -11 scoring systemFor patientphysician satisfaction5-point Likert scale will be used In the follow-up of RIBB patients if the patient expresses pain or NRS4 1 g acetaminophen will be administered intravenously
In the control grouppatients will be administered LA using standard methodsIf necessaryin postoperative period 1 g Acetominophen will be given intravenously every 8 hours
Pain occurs especially during venous puncture surgical incisionopening a pocket for the ICD battery and battery insertionAlthough LA is often applied to cover the superficial tissue puncture areas and pocket areas before the procedure it may be insufficient to completely eliminate painPatients experience instability in intraoperative and postoperative hemodynamics due to painInstable hemodynamics in cardiac patients increases the frequency of undesirable cardiac eventsWith increasing painpatients move during the operationthe procedure time is prolonged and complications such as bleedingunwanted vascular injury surgical incisions and electrode malposition increaseThe first aim of the study is to investigate the efficiency of RIBwhich is practical to apply with USG and has low complicationsin ICD patientsSecondary aim is to investigate patient and physician satisfaction in ICD implantation cases where RIB will be applied
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