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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT05553366
Eligibility Criteria:
Key Inclusion Criteria:
* Before Surgery
* Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
* After Surgery
* Participant is lucid and able to follow commands
* All analgesic guidelines were followed during and after the bunionectomy
Key Exclusion Criteria:
* Before Surgery
* Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
* History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
* Any prior surgery within 1 month before the first study drug dose
* After Surgery
* Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
* Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05553366
Study Brief:
Protocol Section:
NCT05553366