Official websites use. Share sensitive information only on official, secure websites. Correspondence to Professor Helene Beloeil; helene. Reducing opioid consumption during and after surgery has been recommended for more than 10 years.
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. The POFA trial is a prospective, randomised, parallel, single-blind, multicentre study of patients undergoing elective intermediate or major non-cardiac surgery.
Patients will be randomly allocated to receive either a standard anaesthesia protocol or an OFA. 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. The POFA trial has been approved by an independent ethics committee for all study centres.
Participant recruitment begins in November Results will be published in international peer-reviewed medical journals. NCT ; Pre-results. The POFA trial is the first prospective, randomised, parallel, single-blind, multicentre study evaluating the effect of opioid-free anaesthesia OFA on severe postoperative opioid-related adverse events. The multicentre design, broad inclusion criteria, large sample size patients and follow-up will support external validity. Other type of OFAs ie, using clonidine will not be tested.
Synthetic opioids were introduced to achieve haemodynamic stability during anaesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anaesthesia has changed from inhalation to multimodal anaesthesia with lower doses of hypnotic. In , the intraoperative objectives of hypnosis, haemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids.
