Bunion, Post-operative Pain
Conditions
Brief summary
Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.
Detailed description
After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards. The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.
Interventions
DRUGLocal anesthetic injection of CPL-01
Local anesthetic injection (CPL-01)
DRUGNaropin, 0.5% Injectable Solution
Local anesthetic injection (positive control \[Naropin\])
DRUGPlacebo
Local anesthetic injection (negative control \[saline placebo\])
DRUGMorphine rescue medication
Rescue opioid (IV morphine) allowed if requested
DRUGAcetaminophen rescue medication
Rescue non-opioid (oral acetaminophen) allowed if requested
DRUGOxycodone rescue medication
Rescue opioid (PO oxycodone) allowed if requested
PROCEDUREBunionectomy
Operative bunion repair
Sponsors
Cali Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ability to sign ICF * Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * BMI ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant over the study * If biologically male, either sterile or using acceptable form of birth control * Be willing and able to complete study procedures
Exclusion criteria
* Has previously undergone unilateral simple bunionectomy. * Has a planned concurrent surgical procedure * Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments * Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments. * Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Has history or evidence of impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN). * Has a history of malignancy in the past year * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Pain Score | 72 hours | Area Under the Curve of the Numeric Rating Scale Score for Pain with Activity. Activity is resting the operative foot with the ball on the floor. Pain Score spans from 0 to 10, where 0 is no pain and 10 is worst pain imaginable. |
Countries
United States
Contacts
STUDY_DIRECTORErol Onel
Cali Biosciences
Outcome results
None listed