Trial Outcomes & Findings for Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty (NCT NCT02349542)

NCT ID: NCT02349542

Last Updated: 2017-08-31

Results Overview

Number of Participants with Adverse Events

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 72 hours following injection
• Results posted on: 2017-08-31

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty. Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure

Liposomal Bupivacaine Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty. Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Overall Study Withdrawal by Subject

5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=15 Participants Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty. Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
Age, Continuous	60 years n=15 Participants
Sex: Female, Male Female	9 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=15 Participants
Region of Enrollment United States	15 Participants n=15 Participants
Body Mass Index	30.7 kilograms per meters-squared n=15 Participants

PRIMARY outcome

Timeframe: Up to 72 hours following injection

Number of Participants with Adverse Events

Outcome measures

Measure

Liposomal Bupivacaine n=15 Participants Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty. Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Adverse Events

0 participants

SECONDARY outcome

Timeframe: Up to 72 hours following injection

Population: Blood draws were collected at the pre-defined intervals unless the patient was discharged prior to the blood collection time. 6 patients were discharged prior to the 48 hour collection time. 5 additional patients were discharged prior to the 72 hour collection time.

Blood samples will be drawn and analyzed to establish levels of bupivacaine detectable in the blood. Blood samples will be drawn at baseline (prior to injection), upon injection, at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours post-injection and analyzed to determine levels of bupivacaine present.

Outcome measures

Measure	Liposomal Bupivacaine n=15 Participants Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty. Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
Plasma Bupivacaine Levels Baseline (Pre-Injection)	0 ug/ml Standard Deviation 0
Plasma Bupivacaine Levels Immediately Following Injection	0.22 ug/ml Standard Deviation 0.25
Plasma Bupivacaine Levels 15 minutes after injection	0.31 ug/ml Standard Deviation 0.25
Plasma Bupivacaine Levels 30 minutes after injection	0.35 ug/ml Standard Deviation 0.21
Plasma Bupivacaine Levels 1 hour after injection	0.47 ug/ml Standard Deviation 0.21
Plasma Bupivacaine Levels 2 hours after injection	0.53 ug/ml Standard Deviation 0.21
Plasma Bupivacaine Levels 4 hours after injection	0.56 ug/ml Standard Deviation 0.26
Plasma Bupivacaine Levels 8 hours after injection	0.63 ug/ml Standard Deviation 0.20
Plasma Bupivacaine Levels 12 hours after injection	0.56 ug/ml Standard Deviation 0.25
Plasma Bupivacaine Levels 24 hours after injection	0.71 ug/ml Standard Deviation 0.22
Plasma Bupivacaine Levels 48 hours after injection	0.80 ug/ml Standard Deviation 0.37
Plasma Bupivacaine Levels 72 hours after injection	0.43 ug/ml Standard Deviation 0.22

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Research Scientist

OrthoCarolina Research Institute

Phone: 704-323-2260

Email: susan.odum@orthocarolina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place