Trial Outcomes & Findings for Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty (NCT NCT02284386)
NCT ID: NCT02284386
Last Updated: 2021-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Results posted on
2021-03-08
Participant Flow
Participant milestones
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=15 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Age, Continuous
|
67.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Population: Of 15 subjects, one subject was removed as an outlier
Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=14 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
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|---|---|
|
Maximum Plasma Concentration (Cmax)
|
408 ng/mL
Standard Deviation 161
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=15 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Time to Peak Plasma Concentration (Tmax)
|
12.0 hours
Interval 0.47 to 52.5
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=14 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)
|
15286 hours x ng/mL
Standard Deviation 8017
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=10 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)
|
13741 hours x ng/mL
Standard Deviation 4627
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=10 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
The Apparent Terminal Elimination Rate Constant (λz)
|
0.0523 1/hours
Standard Deviation 0.0164
|
PRIMARY outcome
Timeframe: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14Outcome measures
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=10 Participants
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
The Apparent Terminal Elimination Half-life (t1/2el)
|
14.7 hours
Standard Deviation 5.44
|
Adverse Events
Bupivacaine SNB + EXPAREL Infiltration
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivacaine SNB + EXPAREL Infiltration
n=15 participants at risk
Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • 14 days
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • 14 days
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
13.3%
2/15 • 14 days
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
1/15 • 14 days
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • 14 days
|
|
Investigations
Blood Pressure Increased
|
6.7%
1/15 • 14 days
|
|
Investigations
Body Temperature Increased
|
6.7%
1/15 • 14 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • 14 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place