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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT02228759
Eligibility Criteria:
Inclusion Criteria:
1. Male and females of 40-70years of age
2. Scheduled to undergo unilateral primary total knee arthroplasty
3. ASA Class I, II
Exclusion Criteria:
1. ASA 3, 4
2. Revision surgery
3. Narcotic dependent (opioid intake morphine equivalent \> 10 mg/ day for more than 3 months)
4. Other sources of chronic pain like fibromyalgia
5. Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)
6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease
7. Recent MI/ Stroke/ CHF (in the past 3 months)
8. BMI\> 35
9. Obstructive sleep apnea (AHI \> 15)
10. Patients with coexisting hematological disorder or with deranged coagulation parameters.
11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
12. Psychiatric illnesses
13. Uncontrolled diabetes mellitus
14. Lack of informed consent.
15. Allergy to any of the drugs used in the study
16. Preoperative neurological deficits
17. Use of walking aids preoperatively
18. Living alone (Lack of Chaperone/home help)
19. Language barrier
20. Contralateral leg weakness
21. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02228759
Study Brief:
Protocol Section:
NCT02228759