Open heart surgery – does it have to hurt that much? PACS – Parasternal After Cardiac Surgery. A prospective randomised study to assess the analgesic effect of a continuous bilateral parasternal block with lidocaine after sternotomy.

INTERVENTION: Trade Name: Xylocain Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Other use (Noncurrent) CONDITION: The analgesic effect of continuous bilateral parasternal infusion of local anaesthetic after open cardiac surgery. Therapeutic area: Body processes [G] ‐ Physiological processes [G07] PRIMARY OUTCOME: ; Main Objective: The study will test the hypothesis that a continuous bilateral parasternal block with lidocaine will decrease postoperative pain after sternotomy for open cardiac surgery.; Primary end point(s): Cumulated intravenous PCA (Patient Controlled Analgesia) morphine consumption at 72 hours Secondary Objective: The study will evaluate whether improved analgesia by a continuous parasternal block will increase postoperative recovery. Timepoint(s) of evaluation of this end point: After 72 hours SECONDARY OUTCOME: ; Secondary end point(s): • Cumulated NRS (Numeric Rating Scale) score for pain every 8 hours at 72 hours; • QoR‐15 (Quality of Recovery questionnaire) score at 24,48 and 72 hours as well as 2, 4, 8 and 12 weeks after surgery; • NRS at rest at all time points during initial 72 hours; • NRS score at rest and in movement at 2, 4, 8 and 12 weeks after surgery; • Morphine consumption at 24, 48 and 72 hours; • Oxycodon requirement at 2, 4, 8 and 12 weeks after surgery; • Cumulated NRS after two deep breaths three times daily, during 72 hours; • NRS after two deep breaths three times daily, during 72 hours; • NRS at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery; • Incidence of nausea and/or vomiting at any time during initial 72 hours; • Incidence of sedation at any time during initial 72 hours; • Incidence of arrhythmia, more than single or solitary coupled supraventricular and ventricular extra beats at any time during initial 72 hours; • Spirometry preoperatively, and then postoperatively at the morning after surgery and in the evening from day after surgery until postoperative day 3; • Plasma levels of stress markers and lidocaine 1, 24, 48 and 72 hours postoperatively compared to preoperative values; • Day of discharge and discharge time; ; Timepoint(s) of evaluation of this end point: Please see E.5.2; INCLUSION CRITERIA: • Age 20 to 80 years • ASA 2‐3 (American Society of Anesthesiologists) Physcial Status Class 2‐3 • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40