UnknownPhase 3

Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

France140 participantsStarted 2021-07-12

Plain-language summary

Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain. Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Surgery lasting more than 90 minutes with planned use of morphine analgesics during post-operative hospitalization (outside the PACU stay), * ENT surgery, plastic and reconstructive surgery, digestive and visceral surgery, urological surgery and gynecological surgery, * Surgery that does not involve any bone procedure, * Written consent of the patient, * French-speaking patient, able to understand and answer a questionnaire, * Social security affiliation Exclusion Criteria: * Pregnant, breastfeeding or parturient woman, * Person deprived of liberty by judicial or administrative decision, * A person who is subject to a legal protection measure, * Person unable to express consent, * BMI \< 18 and \> 39 kg/m2, * Drug contraindications, in particular hypersensitivity to the active substances of one of the study drugs (in particular lidocaine hydrochloride or amide- or clonidine-linked local anaesthetics) or to one of the excipients, * Porphyria, * Heart failure or unstable coronary artery disease, * bradyarrhythmia due to sinus node disease or conduction clock, or Adam-Stock's syndrome, not fitted, * Hepatocellular insufficiency with TP \< or =50%, * Chronic renal failure with glomerular filtration \< 60 ml/min. * Long-term treatment with Imipraminics, Neuroleptics, Baclofen, and all other molecules at risk of QT prolongation, * Uncontrolled epilepsy, * Chronic treatment with beta-blockers, * Need for induction in fast sequence, * Severe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FQoR-15 score at 24 hours

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT04797312

SponsorUniversity Hospital, Angers

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-11

Contact for this trial

Maxime Léger, MD

241353635 maxime.leger@chu-angers.fr

View on ClinicalTrials.gov More Anesthesia trials