Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid free anesthesia (OFA) protocol | Experimental |
| |
| standard practice protocol based on the use of opioids (sufentanil or remifentanil) | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 and 72 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime Léger, MD | Contact | 241353635 | +33 | maxime.leger@chu-angers.fr |
| Béatrice Gable | Contact | 241356825 | +33 | begable@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maxime Léger, MD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Angers | Recruiting | Angers | 49000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32654751 | Background | 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. | |
| 29739542 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The arm allocation is open for the anesthesia team and caregivers but the patient is blind.
|
| 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. |
|
| 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. | 6, 12, 24, 48 and 72 hours after surgery |
| Opioid consumption | Amount of opioid consumption in the 7 days, assessed by a blinded investigator. | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 24 hours after surgery |
| 34838109 | Derived | 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. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided