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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449599
• Other study ID #: 015
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: June 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Gozde Altun
• Phone: +905544290333
• Email: gozde.altun[@]iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 years of age,

• no previous ICD or Pacemaker implantation attempt

• ASA ( American Society of Anesthesiologists ) score of 2-3,

• INR < 2.0 ,

• Signing the volunteer consent form,

• Patients who met the study criteria will be included in the study.

Exclusion Criteria:

• Morbidly obese patients (BMI>35 kg/m2),

• Advanced decompensated heart failure with New York Heart Association (NYHA) stage 4,

• Having severe chronic obstructive pulmonary disease,

• Allergy to the prescribed medications ,

• Those who have a skin infection or lesion in the area to be blocked,

• Cannot be communicated and cannot be given a position,

• Severe psychosis and progressive neurological deficits and muscle disease,

• ICD/ Pacemaker revision or upgrade to be made,

• ICD battery replacement

• Pregnant patients will be excluded from the study.

Related Conditions & MeSH terms

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

Intervention

Device:
• ultrasound
local anesthesia 400 mg prilocaine (priloc 2%, 20 ml, Vemilac,Türkiye) to surgical field and additionally ultrasound-guided rhomboid intercostal plane block 0,25% bupivacaine 20 ml (Buvasin 0,5%, 20 ml, Vemilac, Türkiye) will be applied to the patients who will be inserted implantable cardioverter defibrillator.

Procedure:
• parenteral local anesthesia
only local anesthesia 400 mg prilocaine (priloc 2%, 20 ml, Vemilac,Türkiye) to surgical field will be applied to the patients who will be inserted implantable cardioverter defibrillator.

Locations

Country	Name	City	State
Turkey	Istanbul Universtiy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain will be assessed by the Numeric Rating Scale-11(NRS -11). Minimum pain score is point zero, maximum pain score is ten points.	to measure the analgesic efficacy of RIB	4 months
Primary	Investigation patient and physician satisfaction assessed by 5-point Likert scale. One point represents strongly unsatisfied and 5 points represent strongly satisfied.	For patient and physician satisfaction;5-point Likert scale will be used.	4 months