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:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02685735
Eligibility Criteria:
Inclusion Criteria:
* Adults scheduled for elective total knee or hip replacement
* American Society of Anesthesiologists physical status 1-3
* Participants must be able to read and write English
Exclusion Criteria:
* Inability to complete questionnaires
* Pregnancy
* Litigation or workers compensation related to joint surgery
* For 250 subjects in primary analysis - taking \< 100 mg morphine equivalents/day. For 50 subjects to test gabapentin's effect on pupil diameter - taking \>100 mg morphine equivalents/day
* history of Raynaud's disease of the feet
* suffering from a psychotic disorder or a recent psychiatric hospitalization
* history of eye surgery or topical eye medications that would render pupillometry unreliable or would directly affect pupil diameter.
* any disorder that would affect pupil responsivity or prevent accuracy of pupillometry such as movement disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02685735
Study Brief:
Protocol Section:
NCT02685735