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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT02449369
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-85
2. Primary, unilateral total knee arthroplasty
3. American Society of Anesthesiologist (ASA) physical status I, II, or III
Exclusion Criteria:
1. Chronic pain (as determined by regular opioid use in the month preceding surgery)
2. Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
3. Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
4. Severe renal dysfunction, creatinine \> 2.0
5. Allergy or other contraindications to use of orphenadrine and/or acetaminophen
6. Pregnant or breast feeding
7. Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
8. History of Hepatitis, B or C,
9. History of cirrhosis or hepatic insufficiency
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02449369
Study Brief:
Protocol Section:
NCT02449369