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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03682302
Eligibility Criteria:
Inclusion Criteria:
1. Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
2. American Society of Anesthesiologists (ASA) Class 1-3.
3. Male or female subjects 6 to less than 17 years of age on the day of surgery.
4. Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
5. A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
6. Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
7. Subjects must be able to adhere to the study visit schedule and complete all study assessments.
Exclusion Criteria:
1. Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
2. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
3. Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
4. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
5. Subjects with coagulopathies or immunodeficiency disorders.
6. History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
7. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.
8. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:
9. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03682302
Study Brief:
Protocol Section:
NCT03682302