Status:
COMPLETED
Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement
Lead Sponsor:
Hôpital Privé Sévigné
Conditions:
Rehabilitation
Analgesia
Eligibility:
All Genders
18-85 years
Brief Summary
Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found a benefit from t...
Eligibility Criteria
Inclusion
- Age 18 and 85
- ASA (American Society of Anesthesiology) I-III
- Total Hip Prosthesis programmed anteriorly
- Prior obtaining free and informed written consent .Affiliation or beneficiary of a social security scheme. Patients affiliated with or beneficiaries of a social security plan and not included in another trial.
Exclusion
- Pregnant women or breastfeeding Spinal anesthesia Patient on long-term opiate Body Mass Index (BMI) - 20 or 45kg/m2 Incomprehension of the ENS scale Unaccompanied cardiac conduction disorder, Adam-Stokes syndrome Preoperative Spontaneous Cardiac Frequency - 40 beats/min Left ventricle ejection fraction - 40% Unpaired sleep apnea syndrome (OSA) Adult incompetent, adults under guardianship or curatorial or deprived of liberty Allergy to one of the protocol products or their excipients: levobupivacaine, paracetamol, pregabalin, ketoprofen, dexmedetomidine Paracetamol-specific contraindication: hepatocellular deficiency Ketoprofen-specific contraindications: creatinine clearance - 60ml/min, ATCD of perforated peptic ulcer, heart failure, progressive hemorrhage, asthma associated with ketoprofen use Contraindications to nefopam: symptomatic prostate disorders, angle-closing glaucoma, epilepsy Participation in another clinical study
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04112277
Start Date
April 1 2019
End Date
February 25 2020
Last Update
February 26 2020
Active Locations (1)
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1
Hopital Privé Sévigné
Cesson-Sévigné, France, 35510