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Completed

NCT Number: NCT04112277

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

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.

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Key information

Conditions

Rehabilitation Agnosia Analgesia Anesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Privé Sévigné

Cesson-Sévigné, 35510, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cumulative morphine consumption

Drug

morphine equivalent [mg] 24 hours after the procedure

Primary outcomes

  1. Cumulative morphine consumption

    Time frame: 24 hours after the procedure

    morphine equivalent [mg]

Sponsors and collaborators

Lead sponsor

Hôpital Privé Sévigné

Other

Registry information

Acronym: ASOPHA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2019
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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