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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT04471233
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age 18-80
4. Undergoing primary unilateral TKA for primary osteoarthritis
5. English speaking
6. Patients whose primary residence is in a home and not a facility or rehabilitation center.
Exclusion Criteria:
1. Chronic (\>6 months) use of neuromodulators pregabalin or gabapentin.
2. Pregnancy or lactation
3. Prior history of adverse reactions to pregabalin
4. Coexisting chronic pain condition rated ≥50mm on 100-mm VAS requiring narcotics.
5. Coexisting condition leading to sedation or dizziness
6. Kidney disease
7. History of angioedema
8. History of depression with suicidal ideation.
9. Extensive history of opioid/ substance use and/or abuse.
10. Receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant.
11. Patient staying less than one night in the hospital.
12. Patients with a history of chronic obstructive pulmonary disease (COPD) with supplementary oxygen requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04471233
Study Brief:
Protocol Section:
NCT04471233