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

Primary Purpose

Anesthesia, Anesthesia; Adverse Effect, Opioid Analgesic Adverse Reaction

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Opioid Free Anaesthesia protocol
standard practice protocol based on the use of opioids (sufentanil or remifentanil)
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia, Quality of recovery, patient centered outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital of AngersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Opioid free anesthesia (OFA) protocol

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

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

FQoR-15 score at 48 and 72 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.
Pain on effort at 6, 12, 24, 48 and 72 hours
Pain evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain) assessed by a blinded nurse.
Opioid consumption
Amount of opioid consumption in the 7 days, assessed by a blinded investigator.
Proportion of patient with at least one POMS complication at 24, 48 and 72 hours
POMS complication as described in the Post-operative Morbidity Survey, assessed by a blinded investigator.
Surgeon satisfaction at day 1
satisfaction concerning the protocole evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain)
anesthesiologist satisfaction at day 1
satisfaction concerning the protocole evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain)
Incidence of hemodynamic, rhythmic and allergic complications at day 1
Hemodynamic tolerance: the need to introduce catecholamines intraoperatively, or the need to stop one of the treatments in the protocol for hemodynamic reasons, Rhythmic tolerance: episode of extreme bradycardia < 35 bpm or tachycardia > 140 bpm for more than 30 seconds, The occurrence of a hypersensitivity reaction or other adverse events attributable to the anesthesia protocol. The complications are collected by the anesthesia team.
Proportion of patients with chronic pain at 3 months
Proportion of patients with chronic pain at 3 months detecting with brief pain inventory, assessed by a blinded investigator.
Quality of life measured from EQ VAS (EQ-5D-3L)
The Quality of life is evaluated via EQ VAS (derivating from the 5-level EQ-5D version (EQ-5D-3L), by a blinded assessor. The value from this scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine'. The scale is rated from 0 to 100.
Proportion of neuropathic pain at 3 months
The proportion of patients reporting neuropathic pain is defined by the DN4 questionnaire by a phone call with a blinded investigator. If the score is equal to or greater than 4/10, we define the presence of neuropathic pain.
Proportion of respect of the allocated anesthesia protocol
Respect of the allocated protocol by the anesthesia team: OFA protocol will be considered complete if at least two of the following drugs are used between ketamine, lidocaine, clonidine and magnesium sulfate, and if no intraoperative opioids are used; the standard group will be considered complete if lidocaine, clonidine or magnesium sulfate are not used intra-operatively. This outcome is collected by one of the investigator.

Full Information

First Posted
February 10, 2021
Last Updated
October 5, 2021
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04797312
Brief Title
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Acronym
SOFA
Official Title
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Anesthesia; Adverse Effect, Opioid Analgesic Adverse Reaction, Post-Op Complication
Keywords
Anesthesia, Quality of recovery, patient centered outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The arm allocation is open for the anesthesia team and caregivers but the patient is blind.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid free anesthesia (OFA) protocol
Arm Type
Experimental
Arm Title
standard practice protocol based on the use of opioids (sufentanil or remifentanil)
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Opioid Free Anaesthesia protocol
Intervention Description
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
Intervention Name(s)
standard practice protocol based on the use of opioids (sufentanil or remifentanil)
Intervention Description
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.
Primary Outcome Measure Information:
Title
FQoR-15 score at 24 hours
Description
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.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
FQoR-15 score at 48 and 72 hours
Description
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.
Time Frame
48 and 72 hours after surgery
Title
Pain on effort at 6, 12, 24, 48 and 72 hours
Description
Pain evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain) assessed by a blinded nurse.
Time Frame
6, 12, 24, 48 and 72 hours after surgery
Title
Opioid consumption
Description
Amount of opioid consumption in the 7 days, assessed by a blinded investigator.
Time Frame
7 days
Title
Proportion of patient with at least one POMS complication at 24, 48 and 72 hours
Description
POMS complication as described in the Post-operative Morbidity Survey, assessed by a blinded investigator.
Time Frame
24, 48 and 72 hours
Title
Surgeon satisfaction at day 1
Description
satisfaction concerning the protocole evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain)
Time Frame
day 1
Title
anesthesiologist satisfaction at day 1
Description
satisfaction concerning the protocole evaluated via a 11-item analogue scale (from 0 to 10, with 10 for the worst pain)
Time Frame
day 1
Title
Incidence of hemodynamic, rhythmic and allergic complications at day 1
Description
Hemodynamic tolerance: the need to introduce catecholamines intraoperatively, or the need to stop one of the treatments in the protocol for hemodynamic reasons, Rhythmic tolerance: episode of extreme bradycardia < 35 bpm or tachycardia > 140 bpm for more than 30 seconds, The occurrence of a hypersensitivity reaction or other adverse events attributable to the anesthesia protocol. The complications are collected by the anesthesia team.
Time Frame
day 1
Title
Proportion of patients with chronic pain at 3 months
Description
Proportion of patients with chronic pain at 3 months detecting with brief pain inventory, assessed by a blinded investigator.
Time Frame
3 months
Title
Quality of life measured from EQ VAS (EQ-5D-3L)
Description
The Quality of life is evaluated via EQ VAS (derivating from the 5-level EQ-5D version (EQ-5D-3L), by a blinded assessor. The value from this scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine'. The scale is rated from 0 to 100.
Time Frame
3 months
Title
Proportion of neuropathic pain at 3 months
Description
The proportion of patients reporting neuropathic pain is defined by the DN4 questionnaire by a phone call with a blinded investigator. If the score is equal to or greater than 4/10, we define the presence of neuropathic pain.
Time Frame
3 months
Title
Proportion of respect of the allocated anesthesia protocol
Description
Respect of the allocated protocol by the anesthesia team: OFA protocol will be considered complete if at least two of the following drugs are used between ketamine, lidocaine, clonidine and magnesium sulfate, and if no intraoperative opioids are used; the standard group will be considered complete if lidocaine, clonidine or magnesium sulfate are not used intra-operatively. This outcome is collected by one of the investigator.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Léger, MD
Phone
241353635
Ext
+33
Email
maxime.leger@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Béatrice Gable
Phone
241356825
Ext
+33
Email
begable@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime Léger, MD
Organizational Affiliation
Angers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Léger, MD
Phone
683134722
Ext
+33
Email
maxime.leger@chu-angers.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32654751
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.
Results Reference
background
PubMed Identifier
29739542
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.
Results Reference
background
PubMed Identifier
34838109
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.
Results Reference
derived

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

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