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

NCT04112277 | Completed

• 1 other identifier: 2018-A03393-52
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Analgesia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Cumulative morphine consumption

  morphine equivalent \[mg\]

  24 hours after the procedure

Interventions

Cumulative morphine consumption DRUG

morphine equivalent \[mg\] 24 hours after the procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Privé Sévigné: lead

Study Sites (1)

Hopital Privé Sévigné

Cesson-Sévigné, 35510, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: April 1, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

FR (1)