Outcomes of rhomboid intercostal plane block on local anaesthesia in cardiac implantable electronic device implantation: a randomized controlled clinical trial
摘要
Rhomboid intercostal plane block (RIB) has been described in the last decade. 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.
MethodsThe randomized controlled trial was structured into two arms, each comprising 25 patients and allocation was performed using a sealed-envelope randomization technique. Local anaesthesia group-LAG received only local anaesthesia (LA) (prilocaine 2%) as the standard procedure. RIB group-RIBG received RIB in addition to the standard procedure. Demographic and clinical data about the patients and the procedures performed were recorded. The first and second rescue treatments in cases of pain during the procedure and the first and second rescue treatments during the postoperative follow-up were also recorded. Pain levels during the procedure, at the end of the procedure and 3, 6, 12, and 24 h after the procedure were determined according to the NRS-11(Numeric Rating Scale-11). Patient and physician satisfaction were recorded on a five-point Likert scale. The primary outcome of the study was the efficacy of RIB in patients undergoing CIED implantation, assessed by NRS-11 pain scores during the procedure and in the postoperative period. As secondary outcome, patient and physician satisfaction levels were evaluated during the procedure.
ResultsThere was less need for additional local anaesthetic in the RIBG than in the LAG (p < 0.001). NRS-11 scores during implantation, at the end of the implantation procedure, and at the 3-, 6-, 12-, and 24-hour follow-ups were greater in the LAG (p < 0.001). The satisfaction levels of both doctors and patients were higher in the RIBG (p < 0.001).
ConclusionsRIB application in CIED implantations showed adequate analgesic efficacy in patients during the perioperative period and up to 24 h postoperatively. At the same time, it provided high procedural satisfaction for patients and physicians. RIB should be considered in the multimodal analgesia approach in the perioperative analgesia of this patient group. There is a need for collaboration between anaesthesiologists and cardiologists to establish protocols, including RIB, for perioperative pain management in patients who undergo CIED implantation.
Trial registrationThis study was registered in the Clinical Trials (ID: NCT06449599, 27/05/2024).