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

Last updated: October 5, 2021
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

3

Condition

Anesthesia

Treatment

N/A

Clinical Study ID

NCT04797312
SOFA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years
  • Surgery lasting more than 90 minutes with planned use of morphine analgesics duringpost-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

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 oneof the study drugs (in particular lidocaine hydrochloride or amide- orclonidine-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'ssyndrome, 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 moleculesat 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 throughquestionnaires.

Study Design

Total Participants: 140
Study Start date:
July 12, 2021
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • University Hospital of Angers

    Angers, 49000
    France

    Active - Recruiting

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