Alparslan Turan1, Emilie P Belley-Cote, Jessica Vincent, Daniel I Sessler, Philip J Devereaux, Salim Yusuf, Rachel van Oostveen, Gustavo Cordova, Jean-Pierre Yared, Hai Yu, Jean-Francois Legare, Alistair Royse, Antoine Rochon, Vivian Nasr, Sabry Ayad, Mackenzie Quantz, Andre Lamy, Richard P Whitlock. 1. From the Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio (A.T., D.I.S., J.-P.Y., V.N., S.A.); Departments of Clinical Epidemiology and Biostatistics (E.P.B.-C., P.J.D., A.L., R.P.W.) and Medicine (P.J.D., S.Y.), McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada (J.V., P.J.D., S.Y., A.L., R.P.W.); Department of Surgery, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada (R.v.O., G.C., A.L., R.P.W.); Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China (H.Y.); Division of Cardiac Surgery, Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada (J.-F.L.); Department of Surgery, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia (A. Royse); Department of Anesthesiology, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada (A. Rochon); and Department of Surgery, London Health Sciences Centre, London, Ontario, Canada (M.Q.).
Abstract
BACKGROUND:Persistent incisional pain is common after cardiac surgery and is believed to be in part related to inflammation and poorly controlled acute pain. Methylprednisolone is a corticosteroid with substantial antiinflammatory and analgesic properties and is thus likely to ameliorate persistent surgical pain. Therefore, the authors tested the primary hypothesis that patients randomized to methylprednisolone have less persistent incisional pain than those given placebo. METHODS:One thousand forty-three patients having cardiopulmonary bypass for cardiac surgery via a median sternotomy were included in this substudy of Steroids in Cardiac Surgery (SIRS) trial. Patients were randomized to 500 mg intraoperative methylprednisolone or placebo. Incisional pain was assessed at 30 days and 6 months after surgery, and the potential risk factors were also evaluated. RESULTS:Methylprednisolone administration did not reduce pain at 30 days or persistent incisional pain at 6 months, which occurred in 78 of 520 patients (15.7%) in the methylprednisolone group and in 88 of 523 patients (17.8%) in the placebo group. The odds ratio for methylprednisolone was 0.93 (95% CI, 0.79 to 1.09, P = 0.37). Furthermore, there was no difference in worst pain and average pain in the last 24 h, pain interference with daily life, or use of pain medicine at 6 months. Younger age, female sex, and surgical infections were associated with the development of persistent incisional pain. CONCLUSIONS:Intraoperative methylprednisolone administration does not reduce persistent incisional pain at 6 months in patients recovering from cardiac surgery.
RCT Entities:
BACKGROUND: Persistent incisional pain is common after cardiac surgery and is believed to be in part related to inflammation and poorly controlled acute pain. Methylprednisolone is a corticosteroid with substantial antiinflammatory and analgesic properties and is thus likely to ameliorate persistent surgical pain. Therefore, the authors tested the primary hypothesis that patients randomized to methylprednisolone have less persistent incisional pain than those given placebo. METHODS: One thousand forty-three patients having cardiopulmonary bypass for cardiac surgery via a median sternotomy were included in this substudy of Steroids in Cardiac Surgery (SIRS) trial. Patients were randomized to 500 mg intraoperative methylprednisolone or placebo. Incisional pain was assessed at 30 days and 6 months after surgery, and the potential risk factors were also evaluated. RESULTS:Methylprednisolone administration did not reduce pain at 30 days or persistent incisional pain at 6 months, which occurred in 78 of 520 patients (15.7%) in the methylprednisolone group and in 88 of 523 patients (17.8%) in the placebo group. The odds ratio for methylprednisolone was 0.93 (95% CI, 0.79 to 1.09, P = 0.37). Furthermore, there was no difference in worst pain and average pain in the last 24 h, pain interference with daily life, or use of pain medicine at 6 months. Younger age, female sex, and surgical infections were associated with the development of persistent incisional pain. CONCLUSIONS: Intraoperative methylprednisolone administration does not reduce persistent incisional pain at 6 months in patients recovering from cardiac surgery.