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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT04639128
Eligibility Criteria:
Inclusion Criteria:
* Intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center
* Patient ambulates independently
Exclusion Criteria:
* Patient declines use of ACC
* Surgeon decides that an ACC will not be placed for any reason
* Known hypersensitivity to ropivacaine or any alternative anesthetic for ACC use
* Hypersensitivity or inability to tolerate peri-articular injections of clonidine, epinephrine, bupivacaine and ketorolac
* Any evidence of substance-use disorder in past year
* Non-English speaking
* Failure to complete all baseline study instruments prior to surgery
* Requires secondary procedure at time of TKA (e.g., removal of hardware)
* Not intending to use spinal anesthesia for TKA procedure
* Actively enrolled in KPNC chronic-pain program
* Having been prescribed long-acting opioid (e.g., Oxycontin, MS Contin) within 90 days prior to enrollment
* Inability to tolerate any oral NSAID or acetaminophen or any short-acting opioid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04639128
Study Brief:
Protocol Section:
NCT04639128