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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02666118
Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female;
* The subject is of any racial and ethnic groups;
* The subject is age 10 years to 21 years (inclusive);
* The subject is scheduled for the following
* Unilateral shoulder repair under general anesthesia on an out- patient basis, and not being performed in conjunction with any other surgical procedures;
* Agreement of the surgeon for subject participation in study.
* The subject or legally authorized representative has consented to an intra- scalene block for the procedure and the consent for the block has been obtained by an clinician (MD, DO, CRNA or APN) authorized to obtain consent who is independent of the study team
* The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
* 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:
* Additional surgical procedures are being performed concurrently;
* The subject is ASA classification \> II;
* The subject has pre-existing allergies to local anesthetics;
* The subject receives sedation preoperatively;
* The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
* 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 preexisting neuropathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT02666118
Study Brief:
Protocol Section:
NCT02666118