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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT01195103
Eligibility Criteria:
Inclusion Criteria:
* Undergoing elective orthopedic surgery
* With a regional block prior to surgery
* Able to consent and complete the assessments and procedures
* If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening
* American Society of Anesthesiologists Physical Classification System status category P1 to P4
Exclusion Criteria:
* History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
* Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01195103
Study Brief:
Protocol Section:
NCT01195103