Clinical trial NCT06449599: RIB for Perioperative Analgesia in CIED Patients
Official title: Outcomes of Rhomboid Intercostal Plane Block on Local Anesthesia in Cardiac Implantable Electronic Device Implantation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Postoperative Pain
Arrhythmias, Cardiac
Keywords: rhomboid intercostal plane block,
postoperative analgesia
cardiac electrophysiology
cardiac implantable electronic devices
arrhythmia
satisfaction
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 4 months
measure: Investigation patient and physician satisfaction assessed by 5-point Likert scale. One point represents strongly unsatisfied and 5 points represent strongly satisfied.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Universtiy
Study officials:
affiliation: Proffessor
name: Kerem Erkalp
role: STUDY_CHAIR
References: