Outcomes of Rhomboid Intercostal Plane Block on Local Anesthesia in Cardiac Implantable Electronic Device Implantation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: ultrasound (Device)
control group
only local anesthesia will be applied to surgical field as a part of the routine procedure.
干预措施: parenteral local anesthesia (Procedure)
结局指标
主要结局
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.
时间窗: 4 months
to measure the analgesic efficacy of RIB
Investigation patient and physician satisfaction assessed by 5-point Likert scale. One point represents strongly unsatisfied and 5 points represent strongly satisfied.
时间窗: 4 months
For patient and physician satisfaction;5-point Likert scale will be used.
次要结局
未报告次要终点
研究者
Kerem Erkalp, MD, Prof
proffessor
Istanbul University - Cerrahpasa