Parasternal After Cardiac Surgery (PACS): a prospective, randomised, double-blinded, placebo-controlled trial study protocol for evaluating a continuous bilateral parasternal block with lidocaine after open cardiac surgery through sternotomy

Multimodal analgesia that provides optimal pain treatment with minimal side effects is important for optimal recovery after open cardiac surgery. Regional anaesthesia can be used to block noxious nerve signals. Because sternotomy causes considerable pain that lasts several days, a continuous nerve block is advantageous. Previous studies on continuous sternal wound infusion or parasternal blocks with long-acting local anaesthetics have shown mixed results. This study aims to determine whether a continuous bilateral parasternal block with lidocaine, which is a short-acting local anaesthetic that has a favourable safety/toxicity profile, results in effective analgesia. We hypothesise that a 72-hour continuous parasternal block with 0.5% lidocaine at a rate of 7 ml/hour on each side provides effective analgesia and reduces opioid requirement. We will evaluate whether recovery is enhanced.

In a prospective, randomised, double-blinded manner, 45 patients will receive a continuous parasternal block with either 0.5% lidocaine or saline. The primary endpoint is cumulated intravenous morphine by patient-controlled analgesia at 72 hours. Secondary end-points include the following: (1) the cumulated numerical rating scale (NRS) score recorded three times daily at 72 hours; (2) the cumulated NRS score after two deep breaths three times daily at 72 hours; (3) the NRS score at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery; (4) oxycodone requirement at 2, 4, 8 and 12 weeks after surgery; (5) Quality of Recovery-15 score preoperatively compared with that at 24, 48 and 72 hours, and at 2, 4, 8 and 12 weeks after surgery; (6) preoperative peak expiratory flow compared with postoperative daily values for 3 days; and (7) serum concentrations of interleukin-6 and lidocaine at 1, 24, 48 and 72 hours postoperatively compared with preoperative values.

Adequate analgesia is important for quality of care and vital to a rapid recovery after cardiac surgery. This study aims to determine whether a continuous parasternal block with a short-acting local anaesthetic improves analgesia and recovery after open cardiac procedures.

The study was registered in the European Clinical Trials Database on 27/9/2019 (registration number: 2018-004672-35).