Bunion, Postoperative Pain
Conditions
Keywords
bunionectomy, bunion, osteotomy
Brief summary
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
DRUGCPL-01
Administration by the Surgeon during the operation
DRUGsaline placebo
Administration by the Surgeon during the operation
Sponsors
Cali Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Bunionectomy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Bunion
Exclusion criteria
* Concomitant conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain with activity | 24 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain with rest | 24 hours, 72 hours | 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) |
| Postoperative rescue medication use | 24 hours, 72 hours | Opioid and non-opioid pain control medicines needed |
Countries
United States
Contacts
CONTACTErol Onel, MD
PRINCIPAL_INVESTIGATORTodd Bertoch, MD
CenExel
Outcome results
None listed