Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery (SOFA)
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| ClinicalTrials.gov Identifier: NCT04797312 |
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Recruitment Status :
Recruiting
First Posted : March 15, 2021
Last Update Posted : October 14, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anesthesia Anesthesia; Adverse Effect Opioid Analgesic Adverse Reaction Post-Op Complication | Drug: Opioid Free Anaesthesia protocol Drug: standard practice protocol based on the use of opioids (sufentanil or remifentanil) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Masking Description: | The arm allocation is open for the anesthesia team and caregivers but the patient is blind. |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery |
| Actual Study Start Date : | July 12, 2021 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | May 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Opioid free anesthesia (OFA) protocol |
Drug: 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. |
| Sham Comparator: standard practice protocol based on the use of opioids (sufentanil or remifentanil) |
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. |
- 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.
- FQoR-15 score at 48 and 72 hours [ Time Frame: 48 and 72 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.
- Pain on effort at 6, 12, 24, 48 and 72 hours [ Time Frame: 6, 12, 24, 48 and 72 hours after surgery ]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 [ Time Frame: 7 days ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 3 months ]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 [ Time Frame: 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 [ Time Frame: 24 hours after surgery ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04797312
| Contact: Maxime Léger, MD | 241353635 ext +33 | maxime.leger@chu-angers.fr | |
| Contact: Béatrice Gable | 241356825 ext +33 | begable@chu-angers.fr |
| France | |
| University Hospital of Angers | Recruiting |
| Angers, France, 49000 | |
| Contact: Maxime Léger, MD 683134722 ext +33 maxime.leger@chu-angers.fr | |
| Principal Investigator: | Maxime Léger, MD | Angers University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT04797312 |
| Other Study ID Numbers: |
SOFA |
| First Posted: | March 15, 2021 Key Record Dates |
| Last Update Posted: | October 14, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Anesthesia Quality of recovery patient centered outcome |
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Postoperative Complications Pathologic Processes Sufentanil Remifentanil Analgesics, Opioid Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General |