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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT04432428
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between 40-75 years old
* Able to give consent
* Scheduled of elective knee arthroplasty with a fast rehabilitation program
* Able to understand PCA principle and capable to operate SSTS device
Exclusion Criteria:
* Outside age range
* Contra indication for anti-inflammatory drugs
* Revision total knee arthroplasty
* history of substance abuse,
* pregnancy,lactation
* severe hepatic impairment (INR\>1,5 and/or AST/ALT above x3 highest normal value),
* sleep apnea (documented by sleep laboratory study),
* severe chronic kidney disease (eGFR\<30 mL/min/1.73 m2),
* severe and very severe COPD (GOLD III and IV)
* opioid tolerance (use of \>15mg oral morphine equivalent per day within the past 3 months),
* chronic pain conditions necessitating gabapentinoids, steroids or anti-inflammatory drugs
* hypersensitivity to sufentanil
* significant respiratory depression (need for outpatient supplemental oxygen therapy),
* participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04432428
Study Brief:
Protocol Section:
NCT04432428