Trial Outcomes & Findings for 0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka (NCT NCT03303794)

NCT ID: NCT03303794

Last Updated: 2020-03-20

Results Overview

AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 25 participants
• Primary outcome timeframe: Post-Operation Day 1
• Results posted on: 2020-03-20

Participant Flow

Participant milestones

Measure	Bupivicaine 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Bupivicaine + Exparel 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bupivicaine n=13 Participants 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Bupivicaine + Exparel n=12 Participants 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=13 Participants	6 Participants n=12 Participants	6 Participants n=25 Participants
Age, Categorical >=65 years	13 Participants n=13 Participants	6 Participants n=12 Participants	19 Participants n=25 Participants
Age, Continuous	71 years n=13 Participants	67 years n=12 Participants	70 years n=25 Participants
Sex: Female, Male Female	10 Participants n=13 Participants	8 Participants n=12 Participants	18 Participants n=25 Participants
Sex: Female, Male Male	3 Participants n=13 Participants	4 Participants n=12 Participants	7 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 Participants n=13 Participants	12 Participants n=12 Participants	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: Post-Operation Day 1

AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.

Outcome measures

Measure	Bupivicaine n=13 Participants 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Bupivicaine + Exparel n=12 Participants 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
AM-PAC Score to Measure Patients Fitness for Discharge	23 score on scale Interval 19.0 to 23.0	23 score on scale Interval 21.0 to 24.0

SECONDARY outcome

Timeframe: During the first 48 hours after surgery

Monitor how much opioid patient consumes

Outcome measures

Measure	Bupivicaine n=13 Participants 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Bupivicaine + Exparel n=12 Participants 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
Opioid Consumption During the First 48 Hours After TKA Surgery	90 milligram Interval 39.0 to 118.0	76 milligram Interval 25.0 to 128.0

SECONDARY outcome

Timeframe: 48 hours postoperatively

Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.

Outcome measures

Measure	Bupivicaine n=13 Participants 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty	Bupivicaine + Exparel n=12 Participants 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
Pain Scores During 48 Hrs Postoperatively	4 score on scale Interval 2.5 to 7.0	4 score on scale Interval 3.0 to 5.0

Adverse Events

Bupivicaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivicaine + Exparel

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

Dr.Singh Nair

Montefiore Medical Center

Phone: 7189205932

Email: sinair@montefiore.org

Results disclosure agreements

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