Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
