RIB for Perioperative Analgesia in CIED Patients

NCT06449599 | Completed

• 1 other identifier: 015
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Rhomboid intercostal plane block (RIB) has been described in the last decade. Various clinical applications have been found to provide hemithorax analgesia. The use of cardiac implantable electronic devices (CIEDs) is increasing due to comorbidities in the elderly population. Increased myocardial stress with pain in these patients may increase the frequency of adverse cardiac events. Therefore, perioperative pain management ensures patient welfare, reduces complications, and maintains stable hemodynamic values. In this study, we aimed to evaluate the outcomes of RIB in terms of perioperative analgesia and patient and physician satisfaction in patients undergoing CIED.

Conditions

Anesthesia; Postoperative Pain; Arrhythmias, Cardiac

Keywords

rhomboid intercostal plane block,; postoperative analgesia; cardiac electrophysiology; cardiac implantable electronic devices; arrhythmia; satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

block group

ACTIVE COMPARATOR

local anesthesia will be applied to surgical field as a part of the routine procedure and additionally rhomboid intercostal plane block will be applied

Device: ultrasound

control group

SHAM COMPARATOR

only local anesthesia will be applied to surgical field as a part of the routine procedure.

Procedure: parenteral local anesthesia

Interventions

ultrasound DEVICE

Local anesthesia 400 mg(20ml) prilocaine 2% to surgical field and additionally ultrasound-guided RIB with 0,25% bupivacaine 20 ml will be applied to the patients who will be inserted cardiac implantable electronic devices An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment. In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol 1 g, IV will be administered with dosing intervals not shorter than 6 hours.

block group

parenteral local anesthesia PROCEDURE

Only local anesthesia 400 mg(20ml) prilocaine 2% prilocaine to surgical field will be applied to the patients who will be inserted cardiac implantable electronic devices. An additional 100 mg of prilocaine will be administered as the first-line rescue treatment if the intraoperative NRS-11 score was ≥4.If the patient has an NRS-11 score of ≥4 again during the procedure,100 mg of prilocaine will be administered again as the second rescue treatment. In the postoperative follow-up of the patients,1 g of paracetamol will be administered IV as an infusion for 20 minutes as the first rescue treatment if the patients have an NRS-11 pain score of ≥4. Two hours after IV paracetamol,if the NRS-11 score≥4, 50 mg of tramadol HCL will be administered IV as the second rescue treatment.In addition, when the NRS score is ≥4 at follow-up, paracetamol (1 g, IV) will be administered with dosing intervals not shorter than 6 hours.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Universtiy

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Arrhythmias, Cardiac; Personal Satisfaction

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kerem Erkalp

  Proffessor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The RIB procedure for the intervention group will be performed in a separate room 60 minutes prior to the patient's transfer to the cardiac electrophysiology laboratory, as described in the methodology section. When the patient arrives at the electrophysiology lab, the cardiologist performing the CIED implantation is not informed whether RIB has been administered beforehand. However, due to the nature of the study, patients are not blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: proffessor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: June 4, 2024
• Primary Completion: October 15, 2024
• Study Completion: January 15, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)