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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT03206320
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
* Age \>18 at the time of informed consent
* ASA I-III physical class
* Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block
Exclusion Criteria:
* History of an allergy or contra-indication to a local anesthetic
* Baseline neurological deficit
* Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
* Presence of preexisting coagulation disorders
* Infection at injection site
* Concomitant opioid therapy
* Recent history (\<3 months) of drug or alcohol abuse
* Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03206320
Study Brief:
Protocol Section:
NCT03206320