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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07449468
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 75 years
* Scheduled for elective primary total hip arthroplasty
* Planned spinal anesthesia
* ASA physical status II-III
* Ability to provide written informed consent
* Ability to communicate and reliably assess pain using the Numeric Rating Scale (NRS)
* Expected postoperative hospitalization ≥ 72 hours
Exclusion Criteria:
* Pre-existing delirium, acute psychosis, or active major psychiatric disorder
* Documented severe dementia or inability to provide informed consent
* Severe hearing or visual impairment preventing reliable CAM assessment
* Contraindications to regional anesthesia (e.g., coagulopathy according to institutional standards, infection at the injection site, allergy to local anesthetics)
* Pre-existing neurological deficits of the operative lower limb are interfering with assessment
* Chronic opioid use (\>30 mg morphine milligram equivalents per day for \>2 weeks prior to surgery)
* Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
* Severe hepatic insufficiency
* Participation in another interventional clinical trial within 30 days
* Any other condition that, in the investigator's judgment, may interfere with study participation or protocol adherence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Maximum Age:
100 Years
Study:
NCT07449468
Study Brief:
Protocol Section:
NCT07449468