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

NCT ID: NCT04797312

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Opioid free anesthesia (OFA) protocol

Group Type: EXPERIMENTAL

Opioid Free Anaesthesia protocol

Intervention Type: DRUG

The OFA protocol begins with a systematic preoperative premedication with clonidine, continues with an adapted intraoperative management without opioid administration, but associating several molecules (clonidine, magnesium, lidocaine, ketamine) and ends with a continued administration of xylocaine up to 1 hour postoperatively in PACU. The use of an opioid in preoperative or intraoperative phases is considered as a deviation from the protocol.

To these different molecules, the use of hypnotic molecules left to the choice of the practitioner and a curare will be systematically associated.

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

Group Type: SHAM_COMPARATOR

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

Intervention Type: DRUG

Standard anesthetic practices can be summed up as the combination of a hypnotic, a morphinic (sufentanil or remifentanil) and a curare. The use of ketamine is allowed.

Interventions

Opioid Free Anaesthesia protocol

The OFA protocol begins with a systematic preoperative premedication with clonidine, continues with an adapted intraoperative management without opioid administration, but associating several molecules (clonidine, magnesium, lidocaine, ketamine) and ends with a continued administration of xylocaine up to 1 hour postoperatively in PACU. The use of an opioid in preoperative or intraoperative phases is considered as a deviation from the protocol.

To these different molecules, the use of hypnotic molecules left to the choice of the practitioner and a curare will be systematically associated.

Intervention Type: DRUG

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

Standard anesthetic practices can be summed up as the combination of a hypnotic, a morphinic (sufentanil or remifentanil) and a curare. The use of ketamine is allowed.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime Léger, MD

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

University Hospital of Angers

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maxime Léger, MD

Role: CONTACT

maxime.leger@chu-angers.fr

241353635 ext. +33

Béatrice Gable

Role: CONTACT

begable@chu-angers.fr

241356825 ext. +33

Facility Contacts

Maxime Léger, MD

Role: primary

maxime.leger@chu-angers.fr

683134722 ext. +33

References

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.

Reference Type: BACKGROUND

PMID: 32654751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29739542 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34838109 (View on PubMed)

Other Identifiers

SOFA

Identifier Type: -

Identifier Source: org_study_id