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Clinical Trials/NCT04112277
NCT04112277
Completed
Not Applicable

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

Hôpital Privé Sévigné1 site in 1 country100 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
Hôpital Privé Sévigné
Enrollment
100
Locations
1
Primary Endpoint
Cumulative morphine consumption
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
February 25, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital Privé Sévigné
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Cumulative morphine consumption

Time Frame: 24 hours after the procedure

morphine equivalent \[mg\]

Study Sites (1)

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