Trial Outcomes & Findings for Open-Label CA-008 (Vocacapsaicin) in Bunionectomy (NCT NCT03885596)
NCT ID: NCT03885596
Last Updated: 2021-10-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
0-72 hours
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
CA-008 Cohort 1
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CA-008 Cohort 1
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
CA-008 4.2 mg
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
Baseline characteristics by cohort
| Measure |
CA-008 (Vocacapsaicin) Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 (Vocacapsaicin) Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 (Vocacapsaicin) Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 6.72 • n=4 Participants
|
45.05 years
STANDARD_DEVIATION 9.65 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-72 hoursPopulation: Safety population
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
Outcome measures
| Measure |
CA-008 Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
|
72.30 score on a scale*hour
Standard Deviation 95.476
|
66.24 score on a scale*hour
Standard Deviation 54.365
|
203.76 score on a scale*hour
Standard Deviation 103.718
|
306.58 score on a scale*hour
Standard Deviation 92.883
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety population
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
Outcome measures
| Measure |
CA-008 Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)
|
0.6 units on a scale
Standard Deviation 0.88
|
1.7 units on a scale
Standard Deviation 1.66
|
5.1 units on a scale
Standard Deviation 1.45
|
6.0 units on a scale
Standard Deviation 1.00
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Safety population
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
Outcome measures
| Measure |
CA-008 Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)
|
1.3 score on a scale
Standard Deviation 2.12
|
0.6 score on a scale
Standard Deviation 0.73
|
2.7 score on a scale
Standard Deviation 2.45
|
4.8 score on a scale
Standard Deviation 2.11
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Safety population
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
Outcome measures
| Measure |
CA-008 Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)
|
1.2 score on a scale
Standard Deviation 2.28
|
0.3 score on a scale
Standard Deviation 0.71
|
2.0 score on a scale
Standard Deviation 2.12
|
4.6 score on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: 0-72 hoursPopulation: Safety population
Summary of opioid consumption in oral morphine equivalents
Outcome measures
| Measure |
CA-008 Cohort 1
n=9 Participants
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 Participants
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 Participants
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Opioid Consumption
|
10.83 mg morphine equivalents
Standard Deviation 27.33
|
3.33 mg morphine equivalents
Standard Deviation 6.61
|
38.33 mg morphine equivalents
Standard Deviation 26.90
|
80.83 mg morphine equivalents
Standard Deviation 66.95
|
Adverse Events
CA-008 Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CA-008 Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CA-008 Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Exparel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CA-008 Cohort 1
n=9 participants at risk
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.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl: 1.5% 12 mL at the end of surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
|
CA-008 Cohort 2
n=9 participants at risk
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Celecoxib: 200 mg PO bid each day postoperative
Acetaminophen Oral: 1 g postoperative
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
CA-008 Cohort 3
n=9 participants at risk
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008: Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
|
Exparel
n=9 participants at risk
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac: 30 mg IV at the onset of anesthesia
Acetaminophen IV: 1 g at the onset of anesthesia
Fentanyl: 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride: 0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride: 2% 15 mL at the end of surgery
Exparel: Bupivacaine liposome injection suspension
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
33.3%
3/9 • Number of events 3 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
33.3%
3/9 • Number of events 3 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Nervous system disorders
Sensory disturbance
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
0.00%
0/9 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
11.1%
1/9 • Number of events 1 • Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place