Phase 3 Bunionectomy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CPL-01, saline placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Bunion. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
Overview
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
Detailed description
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
Interventions
- Drug CPL-01
Administration by the Surgeon during the operation - Drug saline placebo
Administration by the Surgeon during the operation
Primary outcome measures
- Postoperative Pain with activity [Time frame: 24 hours]
Secondary outcome measures (2)
- Postoperative Pain with rest [Time frame: 24 hours, 72 hours]
- Postoperative rescue medication use [Time frame: 24 hours, 72 hours]
Eligibility criteria
Inclusion criteria
- Bunion
Exclusion criteria
- Concomitant conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- CenExel — Salt Lake City
Publications
- Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19. PMID 39303759
Identifiers
NCT: NCT07490496 · CPL-01-3021