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

Anesthesia Clinical Trial

— ASOPHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112277
• Other study ID #: 2018-A03393-52
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: February 2020
• Source: Hôpital Privé Sévigné
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Rehabilitation

Intervention

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

Locations

Country	Name	City	State
France	Hopital Privé Sévigné	Cesson-Sévigné

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Privé Sévigné

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption	morphine equivalent [mg]	24 hours after the procedure