Status:
UNKNOWN
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Lead Sponsor:
University Hospital, Angers
Conditions:
Anesthesia
Anesthesia; Adverse Effect
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04797312
Start Date
July 12 2021
End Date
May 1 2023
Last Update
October 14 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Angers
Angers, France, 49000