The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial

Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimiz...

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Autores principales:	Maxime Léger, Solène Pessiot-Royer, Tristan Perrault, Elsa Parot-Schinkel, Fabienne Costerousse, Emmanuel Rineau, Sigismond Lasocki
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Anesthesia Opioid-free anesthesia Opioid-related adverse effects Quality of recovery Quality of life Perioperative care Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/820694f12836491cbd9337dd8f10dc4c
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spelling	oai:doaj.org-article:820694f12836491cbd9337dd8f10dc4c2021-11-28T12:28:12ZThe effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial10.1186/s13063-021-05829-x1745-6215https://doaj.org/article/820694f12836491cbd9337dd8f10dc4c2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05829-xhttps://doaj.org/toc/1745-6215Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. Methods The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. Discussion This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. Trial registration ClinicalTrials.gov NCT04797312. Registered on 15 March 2021Maxime LégerSolène Pessiot-RoyerTristan PerraultElsa Parot-SchinkelFabienne CosterousseEmmanuel RineauSigismond LasockiBMCarticleAnesthesiaOpioid-free anesthesiaOpioid-related adverse effectsQuality of recoveryQuality of lifePerioperative careMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Anesthesia Opioid-free anesthesia Opioid-related adverse effects Quality of recovery Quality of life Perioperative care Medicine (General) R5-920
spellingShingle	Anesthesia Opioid-free anesthesia Opioid-related adverse effects Quality of recovery Quality of life Perioperative care Medicine (General) R5-920 Maxime Léger Solène Pessiot-Royer Tristan Perrault Elsa Parot-Schinkel Fabienne Costerousse Emmanuel Rineau Sigismond Lasocki The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
description	Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. Methods The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. Discussion This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. Trial registration ClinicalTrials.gov NCT04797312. Registered on 15 March 2021
format	article
author	Maxime Léger Solène Pessiot-Royer Tristan Perrault Elsa Parot-Schinkel Fabienne Costerousse Emmanuel Rineau Sigismond Lasocki
author_facet	Maxime Léger Solène Pessiot-Royer Tristan Perrault Elsa Parot-Schinkel Fabienne Costerousse Emmanuel Rineau Sigismond Lasocki
author_sort	Maxime Léger
title	The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
title_short	The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
title_full	The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
title_fullStr	The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
title_full_unstemmed	The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
title_sort	effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (sofa trial): study protocol for a prospective, monocentric, randomized, single-blinded trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/820694f12836491cbd9337dd8f10dc4c
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The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial

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