Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05277220
Eligibility Criteria:
Inclusion Criteria:
* Person who has received complete information on the organization of the research and has not opposed their participation and the use of their data
* Adult patients,
* ASA score from I to 3 stabilized
* Outpatient orthopedic surgery of the lower limbs scheduled at the CCEG-Regional University Hospital Center of NANCY
* Locoregional anesthesia by spinal anesthesia
* Affiliation to a social security scheme or beneficiary of such a scheme
Exclusion Criteria:
* Documented allergy to one of the agents injected intrathecally
* Uncorrected absolute and / or relative hypovolaemia, as well as situations where the hemodynamics are not stabilized (state of shock, cardiac decompensation, etc.)
* Obstructive heart disease (tight mitral stenosis, tight aortic stenosis, obstructive hypertrophic cardiomyopathy)
* Arterial hypertension uncontrolled
* Constrictive pericarditis
* Obliterating arterial disease of the lower limbs
* Raynaud's syndrome
* Localized infection near the puncture site and / or documented systemic infection
* Infection of the lower limbs like erysipelas
* Hemostatic disorder
* Intracranial hypertension
* Neurodegenerative diseases of the spinal cord
* Congenital malformations (spina bifida)
* Surgical emergency
* Multi visceral failure
* Conventional hospitalization
* Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code:
* Pregnant woman, parturient or nursing mother
* Person deprived of liberty by a judicial or administrative decision
* Person unable to express their consent
* Person undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the Public Health Code
* Minor (not emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05277220
Study Brief:
Protocol Section:
NCT05277220