Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Study Overview
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Brief Summary
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A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Detailed Description
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This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

Official Title
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An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: CA-008
* Drug: Ketorolac
* Drug: Acetaminophen IV
* Drug: Fentanyl
* Drug: Bupivacaine Hydrochloride
* Drug: Lidocaine HCl
* Drug: Celecoxib
* Drug: Acetaminophen Oral
* Drug: Lidocaine Hydrochloride
* Drug: Exparel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult aged 18 - 65 years old American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 Planning elective Bunionectomy repair For both males and females: using an acceptable method of birth control If a female: not pregnant or breastfeeding Have a body mass index ≤ 36 kg/m2 Exclusion Criteria: Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery. Have a known allergy to study medications. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA-008 Cohort 1<br>CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block. | Drug: CA-008<br>* Drug: CA-008 4.2 mg reconstituted in saline<br>* Other names: Vocacapsaicin;Drug: Ketorolac<br>* 30 mg IV at the onset of anesthesia<br>Drug: Acetaminophen IV<br>* 1 g at the onset of anesthesia<br>Drug: Fentanyl<br>* 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery<br>Drug: Bupivacaine Hydrochloride<br>* 0.25% 30 mL (75 mg) prior to surgery<br>Drug: Lidocaine HCl<br>* 1.5% 12 mL at the end of surgery<br>Drug: Celecoxib<br>* 200 mg PO bid each day postoperative<br>Drug: Acetaminophen Oral<br>* 1 g postoperative<br>|
| Experimental: CA-008 Cohort 2<br>CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. | Drug: CA-008<br>* Drug: CA-008 4.2 mg reconstituted in saline<br>* Other names: Vocacapsaicin;Drug: Ketorolac<br>* 30 mg IV at the onset of anesthesia<br>Drug: Acetaminophen IV<br>* 1 g at the onset of anesthesia<br>Drug: Fentanyl<br>* 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery<br>Drug: Bupivacaine Hydrochloride<br>* 0.25% 30 mL (75 mg) prior to surgery<br>Drug: Celecoxib<br>* 200 mg PO bid each day postoperative<br>Drug: Acetaminophen Oral<br>* 1 g postoperative<br>Drug: Lidocaine Hydrochloride<br>* 2% 15 mL at the end of surgery<br>|
| Experimental: CA-008 Cohort 3<br>CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. | Drug: CA-008<br>* Drug: CA-008 4.2 mg reconstituted in saline<br>* Other names: Vocacapsaicin;Drug: Ketorolac<br>* 30 mg IV at the onset of anesthesia<br>Drug: Acetaminophen IV<br>* 1 g at the onset of anesthesia<br>Drug: Fentanyl<br>* 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery<br>Drug: Bupivacaine Hydrochloride<br>* 0.25% 30 mL (75 mg) prior to surgery<br>Drug: Lidocaine Hydrochloride<br>* 2% 15 mL at the end of surgery<br>|
| Active Comparator: Exparel<br>106 mg [8 mL of the 133 mg/10 mL suspension] only All subjects received monitored anesthesia care (MAC) and a Mayo block. | Drug: Ketorolac<br>* 30 mg IV at the onset of anesthesia<br>Drug: Acetaminophen IV<br>* 1 g at the onset of anesthesia<br>Drug: Fentanyl<br>* 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery<br>Drug: Bupivacaine Hydrochloride<br>* 0.25% 30 mL (75 mg) prior to surgery<br>Drug: Lidocaine Hydrochloride<br>* 2% 15 mL at the end of surgery<br>Drug: Exparel<br>* Bupivacaine liposome injection suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h | Area Under the Curve of pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) over 72 hours | 0-72 hours | 
| Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS) | Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 24 hours | 24 hours | 
| Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS) | Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 48 hours | 48 hours | 
| Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS) | Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 72 hours | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Summary of opioid consumption in oral morphine equivalents | 0-72 hours |