Rhomboid Intercostal Block in Cardioverter Defibrillator Implantation (ICD)

Postoperative Pain Clinical Trial

Official title: Efficiency of Ultrasound-Guided Rhomboid Intercostal Block for Cardioverter Defibrillator Implantation (ICD): A Prospective, Randomized-controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

ICD implantation is mostly performed under local anesthesia(LA).With sedation,the patient's anxiety and pain decrease but complications such as respiratory depression and hemodynamic deterioration may occur due to sedation.

Rhomboid intercostal block(RIB) is often applied between the rhomboid major and the intercostal muscle from the midpoint of the medial edge of the scapula.With RIB,cutaneous branches of the thoracic intercostal nerves between T2-T8 are targeted.No studies have been found on the analgesic efficiency of RIB in ICD implantation.

Standard procedure will be applied to the control group(C) (n:25).In RIB group(RIBB)(n:25), LA and RIBB will be performed under USG guidance.

Patients' demographic data,the vessel used to advance ICD lead,the side where the ICD is placed,ICD battery location(subcutaneous,subfascial,subpectoral),procedure duration, complications seen during the procedure,need for additional analgesics will be recorded.The 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-11(NRS -11) scoring system.For patient&physician satisfaction;5-point Likert scale will be used. In the follow-up of RIBB patients, if the patient expresses pain or NRS≥4, 1 g acetaminophen will be administered intravenously.

In the control group,patients will be administered LA using standard methods.If necessary,in postoperative period 1 g Acetominophen will be given intravenously every 8 hours.

Pain occurs especially during venous puncture, surgical incision,opening a pocket for the ICD battery and battery insertion.Although LA is often applied to cover the superficial tissue, puncture areas and pocket areas before the procedure, it may be insufficient to completely eliminate pain.Patients experience instability in intraoperative and postoperative hemodynamics due to pain.Instable hemodynamics in cardiac patients increases the frequency of undesirable cardiac events.With increasing pain,patients move during the operation,the procedure time is prolonged and complications such as bleeding,unwanted vascular injury, surgical incisions and electrode malposition increase.The first aim of the study is to investigate the efficiency of RIB,which is practical to apply with USG and has low complications,in ICD patients.Secondary aim is to investigate patient and physician satisfaction in ICD implantation cases where RIB will be applied. ;

Related Conditions & MeSH terms

• Anesthesia
• Arrhythmias, Cardiac
• Pain, Postoperative
• Postoperative Pain

• NCT number: NCT06449599
• Study type: Interventional
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Gozde Altun
• Phone: +905544290333
• Email: gozde.altun@iuc.edu.tr
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Completion date: December 15, 2024