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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT05981105
Eligibility Criteria:
Inclusion Criteria:
* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
* Age 18 to 75 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)
* Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
* Lives within one hour of the hospital
* Has a smartphone
Exclusion Criteria:
* Hepatic or renal insufficiency
* Younger than 18 years old and older than 65
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* ASA of III,IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* PCS \> 30
* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
* Patients with severe valgus deformity or flexion contracture
* Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter
* Patients who have no home caregivers in the event if a catheter is to be sent home with the patient
* Patients with planned stay at rehab facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05981105
Study Brief:
Protocol Section:
NCT05981105