• Helene Beloeil, Bruno Laviolle, Cedric Menard, Catherine Paugam-Burtz, Matthias Garot, Karim Asehnoune, Vincent Minville, Philippe Cuvillon, Sebastien Oger, Julien Nadaud, Sylvain Lecoeur, Gerald Chanques, Emmanuel Futier, and SFAR research network.
• CHU Rennes, Pôle Anesthésie et Réanimation, Inserm, NuMeCan, CIC 1414 and Université de Rennes 1, Rennes, France.
• BMJ Open. 2018 Jun 30; 8 (6): e020873.

IntroductionReducing opioid consumption during and after surgery has been recommended for more than 10 years. Opioid-free anaesthesia (OFA) is a multimodal anaesthesia associating hypnotics, NMDA antagonists, local anaesthetics, anti-inflammatory drugs and α-2 agonists. Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesised that the reduced opioid consumption allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.Methods/AnalysisThe POFA trial is a prospective, randomised, parallel, single-blind, multicentre study of 400 patients undergoing elective intermediate or major non-cardiac surgery. Patients will be randomly allocated to receive either a standard anaesthesia protocol or an OFA. The primary outcome measure is the occurrence of a severe postoperative opioid-related adverse event within the first 48 hours after extubation defined as: postoperative hypoxaemia or postoperative ileus or postoperative cognitive dysfunction. In addition, each component of the primary outcome measure will be analysed separately. Data will be analysed on the intention-to-treat principle and a per-protocol basis.Ethics And DisseminationThe POFA trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in November 2017. Results will be published in international peer-reviewed medical journals.Trial Registration NumberNCT03316339; Pre-results.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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