Clinical trial NCT04797312: Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Official title: Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anesthesia
Anesthesia; Adverse Effect
Opioid Analgesic Adverse Reaction
Post-Op Complication
Keywords: Anesthesia
Quality of recovery
patient centered outcome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-03-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: FQoR-15 score at 24 hours
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: FQoR-15 score at 48 and 72 hours
timeFrame: 48 and 72 hours after surgery
measure: Pain on effort at 6, 12, 24, 48 and 72 hours
timeFrame: 6, 12, 24, 48 and 72 hours after surgery
measure: Opioid consumption
timeFrame: 7 days
measure: Proportion of patient with at least one POMS complication at 24, 48 and 72 hours
timeFrame: 24, 48 and 72 hours
measure: Surgeon satisfaction at day 1
timeFrame: day 1
measure: anesthesiologist satisfaction at day 1
timeFrame: day 1
measure: Incidence of hemodynamic, rhythmic and allergic complications at day 1
timeFrame: day 1
measure: Proportion of patients with chronic pain at 3 months
timeFrame: 3 months
measure: Quality of life measured from EQ VAS (EQ-5D-3L)
timeFrame: 3 months
measure: Proportion of neuropathic pain at 3 months
timeFrame: 3 months
measure: Proportion of respect of the allocated anesthesia protocol
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
Study officials:
affiliation: Angers University Hospital
name: Maxime Léger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.
citation: Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.
citation: Leger M, Pessiot-Royer S, Perrault T, Parot-Schinkel E, Costerousse F, Rineau E, Lasocki S. 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. Trials. 2021 Nov 27;22(1):855. doi: 10.1186/s13063-021-05829-x.