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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT03182933
Eligibility Criteria:
Inclusion Criteria:
1. The subject is scheduled for elective unilateral TKA;
2. The subject is ≥ 18 years and ≤ 80 years;
3. The subject's weight is between 65-130 kg;
4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
5. The patient agrees to receive an adductor canal block;
6. American Society of Anesthesiologists class 1-3.
Exclusion Criteria:
1. Subject is \< 18 years of age or \>80 years of age;
2. Subject is non-English speaking;
3. Subject is known or believed to be pregnant;
4. Subject is a prisoner;
5. Subject has impaired decision-making capacity per discretion of the Investigator;
6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
8. Significant pre-existing neuropathy on the operative limb;
9. Significant renal, cardiac or hepatic disease per discretion of the investigator;
10. American Society of Anesthesiologists class 4-5;
11. Known hypersensitivity and/or allergies to local anesthetics;
12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03182933
Study Brief:
Protocol Section:
NCT03182933