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

University Hospital, Angers

Status and phase: Unknown; Phase 3

Conditions: Opioid Analgesic Adverse Reaction; Anesthesia; Adverse Effect; Post-Op Complication; Anesthesia

Treatments: Drug: Opioid Free Anaesthesia protocol; Drug: standard practice protocol based on the use of opioids (sufentanil or remifentanil)

Study type: Interventional

Funder types: Other

Identifiers

NCT04797312

SOFA

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Opioid free anesthesia (OFA) protocol

Experimental group

Treatment:

Drug: Opioid Free Anaesthesia protocol

standard practice protocol based on the use of opioids (sufentanil or remifentanil)

Sham Comparator group

Treatment:

Drug: standard practice protocol based on the use of opioids (sufentanil or remifentanil)