CPL-01 in the Management of Postoperative Pain After Bunionectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo- and Active-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

Conditions
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Bunion

Intervention / Treatment
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* Drug: Local anesthetic injection of CPL-01
* Drug: Naropin, 0.5% Injectable Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPL-01<br>Local infiltration of study drug | Drug: Local anesthetic injection of CPL-01<br>* Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])<br>* Other names: Long-acting ropivacaine;|
| Active Comparator: Ropivacaine HCl<br>Local infiltration of study drug | Drug: Naropin, 0.5% Injectable Solution<br>* Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])<br>* Other names: ropivacaine HCl;|
| Placebo Comparator: Placebo<br>Local infiltration of study drug | Drug: Placebo<br>* Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])<br>* Other names: Saline placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Pain Score | 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. | 72 hours |