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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT02864602
Eligibility Criteria:
Inclusion Criteria:
* ASA 1 (normal healthy) volunteers.
* 18 - 50 years of age.
* 60 - 100kg weight.
* English speaking.
* Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
* Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.
Exclusion Criteria:
* Medical disorders (including bleeding disorders).
* Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
* Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
* Contraindication to regional anesthetic block.
* Inability to provide informed consent.
* Baseline abnormality of hand sensation or motor function.
* Pregnancy / breast feeding.
* Individuals with mental health disorders (for example bipolar disorder or depression).
* Individuals with cataracts or glaucoma.
* Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02864602
Study Brief:
Protocol Section:
NCT02864602