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

  • STATUS
    Recruiting
  • days left to enroll
    58
  • participants needed
    140
  • sponsor
    University Hospital, Angers
Updated on 20 October 2021
analgesics
morphine
ketamine
opioid
remifentanil
sufentanil
lidocaine

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.

Details
Condition sensory loss, anaesthesia, Anesthesia, Opioid Analgesic Adverse Reaction, anesthesia procedures, dental anesthesia, anesthesia for, Anesthesia; Adverse Effect, Postoperative Complication, Anesthesia (Local)
Treatment Opioid Free Anaesthesia protocol, standard practice protocol based on the use of opioids (sufentanil or remifentanil)
Clinical Study IdentifierNCT04797312
SponsorUniversity Hospital, Angers
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

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 psychiatric or cognitive disorder that interferes with the evaluation through questionnaires
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