Nitish K. Dhingra, Fallon Dennis, Syed Mohammad Ali Hassan, Adrian Quan, Hwee Teoh, Kyle Chin, Michael J. Ricci, John D. Tran, Jason li, Raj Verma, Fábio de Vasconcelos Papa, Youngseo Lee, Ashton Chang, Jesús Igualada, JUAN F. MORALES, Juan P. Ghiringhelli, Kendra Derry, Thomas George, Amine Mazine, Ori D. Rotstein, Corey Adams, Richard C. Cook, Ansar Hassan, A Dave Nagpal, Terrence M. Yau, Jessica Spence, Korey Sutherland, Pawel M. Martinka, Christopher Noss, James L. Dougherty, Pieter de Jager, Alexander J. Gregory, Rakesh C. Arora, Subodh Verma, Ahmad Alli, CDavid Mazer
PURPOSE OF THE TRIAL: Inadequate pain control following cardiac surgery remains a significant clinical and socioeconomic burden. Superficial parasternal intercostal plane (SPIP) blocks are not widely utilized for reducing pain and opioid consumption post-cardiac surgery because the available evidence is weak and inconsistent. METHODS: The double-blind, placebo-controlled, multicenter EPOCH CardioLink-10 trial was designed to evaluate how continuous bilateral SPIP blocks affect opioid consumption and recovery-related endpoints among individuals who have undergone cardiac surgery via median sternotomy. Participants from four Canadian sites are randomized to receive either 0.2% ropivacaine or placebo (0.9% sodium chloride) for 48-h following bilateral catheter insertion into the SPIP. The primary outcome is cumulative postoperative opioid use (morphine milligram equivalents) up to 72-hours post-catheter insertion. Secondary endpoints include median pain scores and the incidence of delirium over the 72-hours post-catheter insertion; cumulative postoperative opioid use up to hospital discharge; and participant-reported quality of recovery 24-96 h post-surgery. SUMMARY: EPOCH CardioLink-10 is to date the largest randomized controlled trial to evaluate an Enhanced Recovery After Surgery (ERAS) intervention among individuals who are recuperating from cardiac surgery with median sternotomy. Its overarching goal is to obtain robust data to improve clinical care and inform on post-cardiac surgery pain management guidelines.