AnesthesiaPhase 3SOFANCT04797312
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
A Phase 3 study testing Opioid Free Anaesthesia protocol and standard practice protocol based on the use of opioids (sufentanil or remifentanil) in people with Anesthesia and Anesthesia; Adverse Effect, run by University Hospital, Angers at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Anesthesia; Adverse Effect, Opioid Analgesic Adverse Reaction
- What is being tested?
- Opioid Free Anaesthesia protocol and standard practice protocol based on the use of opioids (sufentanil or remifentanil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2021to May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, 49000
Maxime Léger, MD, 683134722 ext. +33, maxime.leger@chu-angers.fr
About this study
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
- Being tested
- Opioid Free Anaesthesia protocol, standard practice protocol based on the use of opioids (sufentanil or remifentanil)
- Keywords
- Anesthesia, Quality of recovery, patient centered outcome
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free Anaesthesia protocolDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anesthesia (OFA) protocol | Experimental | Not described Receives: Drug: Opioid Free Anaesthesia protocol |
| standard practice protocol based on the use of opioids (sufentanil or remifentanil) | Sham comparator | Not described Receives: Drug: standard practice protocol based on the use of opioids (sufentanil or remifentanil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (11)
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.
Measured: 48 and 72 hours after surgery
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.
Measured: 6, 12, 24, 48 and 72 hours after surgery
Opioid consumption
Amount of opioid consumption in the 7 days, assessed by a blinded investigator.
Measured: 7 days
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.
Measured: 24, 48 and 72 hours
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)
Measured: day 1
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)
Measured: day 1
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.
Measured: day 1
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 Jul 2021
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maxime Léger, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797312
- Sponsor's protocol ID
- SOFA
- Acronym
- SOFA
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32654751Mauermann 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.
PubMed 29739542Leger 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.
PubMed 34838109
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
- ClinicalTrials.gov ID
- NCT04797312
- Acronym / sponsor ID
- SOFA / SOFA
- Conditions
- Anesthesia, Anesthesia; Adverse Effect, Opioid Analgesic Adverse Reaction, Post-Op Complication
- Keywords
- Anesthesia, Quality of recovery, patient centered outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Free Anaesthesia protocolThe 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. | Drug | Opioid free anesthesia (OFA) protocol |
| 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. | Drug | standard practice protocol based on the use of opioids (sufentanil or remifentanil) |
Primary outcome
FQoR-15 score at 24 hours
Time frame: 24 hours after surgery
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.
11 secondary outcomes
FQoR-15 score at 48 and 72 hours
Time frame: 48 and 72 hours after surgery
Pain on effort at 6, 12, 24, 48 and 72 hours
Time frame: 6, 12, 24, 48 and 72 hours after surgery
Opioid consumption
Time frame: 7 days
Proportion of patient with at least one POMS complication at 24, 48 and 72 hours
Time frame: 24, 48 and 72 hours
Surgeon satisfaction at day 1
Time frame: day 1
anesthesiologist satisfaction at day 1
Time frame: day 1
Incidence of hemodynamic, rhythmic and allergic complications at day 1
Time frame: day 1
Proportion of patients with chronic pain at 3 months
Time frame: 3 months
Quality of life measured from EQ VAS (EQ-5D-3L)
Time frame: 3 months
Proportion of neuropathic pain at 3 months
Time frame: 3 months
Proportion of respect of the allocated anesthesia protocol
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Background: PubMed 32654751Leger 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.
- Background: PubMed 29739542Mauermann 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.
- Derived from this study: PubMed 34838109Leger 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Léger, MD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Opioid Free Anaesthesia protocol and standard practice protocol based on the use of opioids (sufentanil or remifentanil) in people with Anesthesia and Anesthesia; Adverse Effect, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime Léger, MD (241353635 ext. +33, maxime.leger@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FQoR-15 score at 24 hours (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797312, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.