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Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPL-01 | Experimental | Intra-operative local administration |
|
| Saline placebo | Placebo Comparator | Intra-operative local administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPL-01 | Drug | Administration by the Surgeon during the operation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain with activity | AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain with rest | AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable) | 24 hours, 72 hours |
| Postoperative rescue medication use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erol Onel, MD | Contact | 203-837-6500 | e.onel@calibiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, MD | CenExel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel | Salt Lake City | Utah | 84107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39303759 | Background | 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. |
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All IPD necessary for results
After approval
As necessary
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Bunionectomy
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| saline placebo |
| Drug |
Administration by the Surgeon during the operation |
|
Opioid and non-opioid pain control medicines needed
| 24 hours, 72 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |