Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty
Study Details
Study Description
Brief Summary
The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively.
Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Total joint arthroplasty (TJA) is a commonly performed surgical procedure that can result in considerable postoperative pain which can limit social and functional recovery and a return to quality of life. Traditionally, pain control following TJA has been conducted with parenteral and oral narcotics. Recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures.1-2 These multimodal regimens vary and consist of any number of medications including narcotics, non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. These multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.3-5 One of the newest modalities introduced on the market is liposomal bupivacaine, trade name Exparel. The advertised advantage of liposomal bupivacaine compared with bupivacaine HCL is a longer duration of analgesia owing to gradual release from the liposomes. Liposomal bupivacaine is employed in a periarticular injection at the conclusion of TJAs to aid in post-operative pain control.
Patients receive a periarticular injection of liposomal bupivacaine intra-operatively during TJA. At the conclusion of the procedure, a specialized intra-articular drain (OrthoPAT®) is placed. The OrthoPAT® perioperative autotransfusion system collects the patient's blood in the immediate postoperative period and then allows for it to be transfused to the patient while on the floor.
A potential risk, although low, is the concern for bupivicaine toxicity. Toxicity from bupivicaine is associated with central nervous system issues (seizures) and cardiac toxicity. Toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. With autotransfusion, there is a theoretical concern that blood, potentially with increased levels of bupivicaine, could be reinfused into the vascular system and create toxicity.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exparel Participants will receive Exparel (periarticular bupivicaine and liposomal bupivicaine). |
Drug: periarticular bupivicaine and liposomal bupivicaine
Participants will receive 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 is administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Blood Serum Levels of Bupivocaine From Baseline [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
-
At least 18 years of age.
Exclusion Criteria:
-
Allergy to bupivacaine.
-
Allergy to epinephrine.
-
Patients that are not presenting for a primary TJA
-
Patients who are having a TJA without OrthoPAT® auto reinfusion system.
-
Patients under age 18.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OrthoCarolina, PA | Charlotte | North Carolina | United States | 28207 |
| 2 | Novant Health Charlotte Orthopedic Hospital | Charlotte | North Carolina | United States | 28209 |
| 3 | OrthoCarolina Research Institute, OrthoCarolina, P.A. | Charlotte | North Carolina | United States | 28209 |
| 4 | OrthoCarolina, PA | Charlotte | North Carolina | United States | 28209 |
Sponsors and Collaborators
- OrthoCarolina Research Institute, Inc.
Investigators
- Principal Investigator: Bryan Springer, MD, Physician
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09-14-13E-9084
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Exparel |
|---|---|
| Arm/Group Description | 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). |
| Period Title: Overall Study | |
| STARTED | 26 |
| COMPLETED | 11 |
| NOT COMPLETED | 15 |
Baseline Characteristics
| Arm/Group Title | Exparalel |
|---|---|
| Arm/Group Description | 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 Participants | 11 |
| Age (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
63
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
36.4%
|
| Male |
7
63.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
11
100%
|
| Surgery Performed (Count of Participants) | |
| Total Hip Arthroplasty |
5
45.5%
|
| Total Knee Arthroplasty |
6
54.5%
|
Outcome Measures
| Title | Change in Blood Serum Levels of Bupivocaine From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Change from baseline at 2 and 5 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Exparalel |
|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 11 |
| 2 Hours Post-Dose |
0.6
|
| 5 Hours Post-Dose |
0.95
|
| 2 & 5 Hours Combined |
0.8
|
Adverse Events
| Time Frame | Hospital discharge following arthroplasty. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Exparel | |
| Arm/Group Description | 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). | |
All Cause Mortality |
||
| Exparel | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Serious Adverse Events |
||
| Exparel | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Exparel | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Senior Research Scientist |
|---|---|
| Organization | OrthoCarolina Research Institute |
| Phone | 704-323-2260 |
| susan.odum@orthocarolina.com |
- 09-14-13E-9084