Trial Outcomes & Findings for Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty (NCT NCT02276040)

Results Overview

Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

Change from baseline at 2 and 5 hours post-dose

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine). periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
Overall Study STARTED	26
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Exparel Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine). periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
Overall Study Physician Decision	15

Baseline Characteristics

Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exparalel n=11 Participants Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine). periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Surgery Performed Total Hip Arthroplasty	5 Participants n=5 Participants
Surgery Performed Total Knee Arthroplasty	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 2 and 5 hours post-dose

Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.

Outcome measures

Outcome measures
Measure	Exparalel n=11 Participants Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine). periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
Change in Blood Serum Levels of Bupivocaine From Baseline 5 Hours Post-Dose	0.95 ug/cc Interval 0.2 to 1.75
Change in Blood Serum Levels of Bupivocaine From Baseline 2 Hours Post-Dose	0.6 ug/cc Interval 0.4 to 1.1
Change in Blood Serum Levels of Bupivocaine From Baseline 2 & 5 Hours Combined	0.8 ug/cc Interval 0.3 to 1.36

Adverse Events

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

Senior Research Scientist

OrthoCarolina Research Institute

Phone: 704-323-2260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place