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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02947633
Eligibility Criteria:
Inclusion Criteria:
A subject may be INCLUDED in this study if:
1. The subject is male or female;
2. The subject is of any racial or ethnic group;
3. The subject is age 10 years to 18 years (inclusive);
4. The subject is scheduled for the following: Unilateral ACL reconstruction with a hamstring autograft under general anesthesia on an outpatient basis, and not being performed in conjunction with any other surgical procedures;
5. The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
6. The subject or legally authorized representative has consented to femoral and sciatic peripheral nerve blockade for the procedure and the consent for peripheral nerve blockade has been obtained by a clinician (MD, DO, CRNA or APN) authorized to obtain consent;
7. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Exclusion Criteria:
A subject will be EXCLUDED from this study if:
1. Additional surgical procedures are being performed concurrently;
2. The subject is ASA classification \> II;
3. The subject has pre-existing allergies to amide local anesthetics;
4. The subject receives sedation preoperatively;
5. The subject is schedule for overnight hospital admission;
6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study, including but not limited to coagulopathy, preexisting central or peripheral nervous systems disorders, and local infection or sores at the anticipated site of needle insertion;
7. Unsuccessful PNB or CPI catheter placement occurs during the study. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT02947633
Study Brief:
Protocol Section:
NCT02947633