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

Anesthesia Clinical Trial

— SOFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797312
• Other study ID #: SOFA
• Status: Recruiting
• Phase: Phase 3
• Start date: July 12, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Angers
• Contact: Maxime Léger, MD
• Phone: 241353635
• Email: maxime.leger[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia; Adverse Effect
• Opioid Analgesic Adverse Reaction
• Post-Op Complication
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

Léger 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Opioid consumption	Amount of opioid consumption in the 7 days, assessed by a blinded investigator.	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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