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Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement (ASOPHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112277
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hôpital Privé Sévigné

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 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.


Condition or disease Intervention/treatment
Rehabilitation Analgesia Anesthesia Drug: Cumulative morphine consumption

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement


Intervention Details:
  • Drug: Cumulative morphine consumption
    morphine equivalent [mg] 24 hours after the procedure


Primary Outcome Measures :
  1. Cumulative morphine consumption [ Time Frame: 24 hours after the procedure ]
    morphine equivalent [mg]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ASA (American Society of Anesthesiology) I-III for whom a total Hip Prosthesis is programmed anteriorly (Hueler Method).
Criteria

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

Information from the National Library of Medicine

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): NCT04112277


Contacts
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Contact: Christophe AVELINE, MD +33 2.99.25.51.25 caveline@vivalto-sante.com

Locations
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France
Hopital Privé Sévigné Recruiting
Cesson-Sévigné, France, 35510
Contact: Christophe AVELINE, MD    +33 2.99.25.51.25    caveline@vivalto-sante.com   
Sponsors and Collaborators
Hôpital Privé Sévigné

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Responsible Party: Hôpital Privé Sévigné
ClinicalTrials.gov Identifier: NCT04112277    
Other Study ID Numbers: 2018-A03393-52
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents