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:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01333956
Eligibility Criteria:
Inclusion Criteria:
* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
* Age 18 to 80 years old
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate
Exclusion Criteria:
* Patients younger than 18 years old and older than 80
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance \< 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr \< 30 mL/min, CLcr=\[(140-age (years)\] x weight (kg)x0.85 (for female patients)/\[72xserum creatinine (mg/dL)\])
* Patients with difficult to manage diabetes mellitus, including insulin-dependence
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with major prior ipsilateral open knee surgery.
* Chronic neurontin/lyrica use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01333956
Study Brief:
Protocol Section:
NCT01333956