Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement (ASOPHA)
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 the ATO on postoperative rehabilitation and reduced length of hospitalization.
Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA during the PTH.
PTH remains a painful procedure and the occurrence of morphinic-related side effects in sometimes elderly patients is often observed.
The main objective of this study is to assess the feasibility of ATO in anterior hip replacement under general anesthesia with the primary endpoint of morphine consumption measured 24 hours after surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cesson-Sévigné, France, 35510
- Hôpital privé Sévigné
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative morphine consumption
Time Frame: 24 hours after the procedure
|
morphine equivalent [mg]
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24 hours after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A03393-52
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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