title: Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial.
abstract: BACKGROUND
  The continuous bilateral infusion of a local anaesthetic solution around the sternotomy wound (bilateral sternal) is an innovative technique for reducing pain after sternotomy.
  
  
  OBJECTIVE
  To assess the effects of the technique on the need for intensive care in cardiac patients at increased risk of respiratory complications.
  
  
  METHODS
  Randomised, observer-blind controlled trial.
  
  
  METHODS
  Single centre, French University Hospital.
  
  
  METHODS
  In total, 120 adults scheduled for open-heart surgery, with one of the following conditions: age more than 75 years, BMI >30 kg m, chronic obstructive pulmonary disease, active smoking habit.
  
  
  METHODS
  Either a bilateral sternal infusion of 0.2% ropivacaine (3 ml h through each catheter; 'intervention' group), or standardised care only ('control' group). Analgesia was provided with paracetamol and self-administered intravenous morphine.
  
  
  METHODS
  The length of time to readiness for discharge from ICU, blindly assessed by a committee of experts.
  
  
  RESULTS
  No effect was found between groups for the primary outcome (P = 0.680, intention to treat); the median values were 42.4 and 37.7 h, respectively for the control and intervention groups (P = 0.873). Similar nonsignificant trends were noted for other postoperative delays. Significant effects favouring the intervention were noted for dynamic pain, patient satisfaction, occurrence of nausea and vomiting, occurrence of delirium or mental confusion and occurrence of pulmonary complications. In 12 patients, although no symptoms actually occurred, the total ropivacaine plasma level exceeded the lowest value for which neurological symptoms have been observed in healthy volunteers.
  
  
  CONCLUSIONS
  Because of a small size effect, and despite significant analgesic effects, this strategy failed to reduce the time spent in ICU.
  
  
  BACKGROUND
  EudraCT (N°: 2012-005225-69); ClinicalTrials.gov (NCT01828788).
authors.affiliation: From the CHU Clermont-Ferrand, Médecine Péri-Opératoire (VE, EI, PS), CHU Clermont-Ferrand, Pharmacie Centrale, Hôpital Gabriel-Montpied (DB), CHU Clermont-Ferrand, Direction de la Recherche Clinique et des Innovations (BP), CHU Clermont-Ferrand, Pôle Cardiologie, Chirurgie Cardio-Vasculaire (MF, KA), Univ Clermont1, Fac Médecine (PS, KA), CHU Clermont-Ferrand, Centre de Pharmacologie Clinique (CD) and Inserm, CIC1405 and U1107 'Neuro-Dol', Clermont-Ferrand, France (CD).
authors.forename: Vedat
authors.initials: V
authors.lastname: Eljezi
authors.forename: Etienne
authors.initials: E
authors.lastname: Imhoff
authors.forename: Daniel
authors.initials: D
authors.lastname: Bourdeaux
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farhat
authors.forename: Pierre
authors.initials: P
authors.lastname: Schoeffler
authors.forename: Kasra
authors.initials: K
authors.lastname: Azarnoush
authors.forename: Christian
authors.initials: C
authors.lastname: Dualé
mesh_terms: D000368:Aged; D000577:Amides / Q000008:administration & dosage*; D000779:Anesthetics, Local / Q000008:administration & dosage*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000639:trends*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D055104:Infusions, Subcutaneous; D007362:Intensive Care Units / Q000639:trends; D007902:Length of Stay / Q000639:trends*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D012120:Respiration Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D012307:Risk Factors; D000077212:Ropivacaine; D056346:Sternotomy / Q000009:adverse effects / Q000639:trends; D013249:Sternum / Q000187:drug effects / Q000601:surgery; D000072836:Surgical Wound / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000577:Amides; D000779:Anesthetics, Local; D000077212:Ropivacaine