RIB for Perioperative Analgesia in CIED Patients

Outcomes of Rhomboid Intercostal Plane Block on Local Anesthesia in Cardiac Implantable Electronic Device Implantation: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Arrhythmias, Cardiac; Anesthesia
• Intervention / Treatment: Device: ultrasound; Procedure: parenteral local anesthesia

Detailed Description

In accordance with the study design, a randomization list for the two groups is generated by an independent individual using a computer-assisted program (www.randomizer.org). Equal numbers of participants are assigned to either the intervention or control group in a 1:1 ratio. Patients included in the study will be randomized into two groups of 25 patients each. One group (local anaesthesia group - LAG) will receive only local anaesthesia (prilocaine 2%) as per the standard procedure of the institution. The other group (RIB group - RIBG) will receive RIB in addition to the standard procedure. Demographic and clinical data regarding the patients and the procedures performed will be recorded. Information about the first and second rescue treatments in cases of pain during the procedure, as well as the first and second rescue treatments during postoperative follow-up, will also be documented in the same database. Pain levels during the procedure, at the end of the procedure, and at 3, 6, 12, and 24 hours postoperatively will be assessed using the NRS-11. Patient and physician satisfaction will be evaluated using a five-point Likert scale. This study aims to evaluate the efficacy of RIB in patients undergoing CIED implantation by performing pain assessments with the Numeric Rating Scale-11 (NRS-11) during the procedure and the postoperative period. As a secondary outcome, patient and physician satisfaction levels will be assessed during the procedure.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: block group; 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; 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.
Sham Comparator: control group; only local anesthesia will be applied to surgical field as a part of the routine procedure.	Procedure: parenteral local anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Study Chair: Kerem Erkalp, Proffessor

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: satisfaction; postoperative analgesia; arrhythmia; cardiac electrophysiology; cardiac implantable electronic devices; rhomboid intercostal plane block,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 015 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No