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

NCT04797312 | Unknown Phase 3

• 1 other identifier: SOFA
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

Anesthesia; Quality of recovery; patient centered outcome

Outcome Measures

Primary Outcomes (1)

• FQoR-15 score at 24 hours

  Value of the French Quality of Recovery-15 score (minimum value of 0 and maximum value of 150, with a higher score for a better outcome). The QoR-15 questionnaires will be completed by the patient himself whenever possible, who could be helped by a nurse blinded to the assignment group, or by phone if the patient has returned home.

  24 hours after surgery

Secondary Outcomes (11)

• FQoR-15 score at 48 and 72 hours

  48 and 72 hours after surgery

• Pain on effort at 6, 12, 24, 48 and 72 hours

  6, 12, 24, 48 and 72 hours after surgery

• Opioid consumption

  7 days

• Proportion of patient with at least one POMS complication at 24, 48 and 72 hours

  24, 48 and 72 hours

• Surgeon satisfaction at day 1

  day 1

Study Arms (2)

Opioid free anesthesia (OFA) protocol

EXPERIMENTAL

Drug: Opioid Free Anaesthesia protocol

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

SHAM COMPARATOR

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

Interventions

Opioid Free Anaesthesia protocol 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.

Opioid free anesthesia (OFA) protocol

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital of Angers

Angers, 49000, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 32654751 BACKGROUND

• 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.

  PMID: 29739542 BACKGROUND

• 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.

  PMID: 34838109 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Sufentanil; Remifentanil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Maxime Léger, MD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime Léger, MD

CONTACT

241353635; maxime.leger@chu-angers.fr

Béatrice Gable

CONTACT

241356825; begable@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The arm allocation is open for the anesthesia team and caregivers but the patient is blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 15, 2021
• Study Start: July 12, 2021
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)