Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Participants will receive Exparel (periarticular bupivicaine and liposomal bupivicaine). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| periarticular bupivicaine and liposomal bupivicaine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Serum Levels of Bupivocaine From Baseline | 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. | Change from baseline at 2 and 5 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting for total knee replacement
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bryan Springer, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28207 | United States | ||
| Novant Health Charlotte Orthopedic Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients that completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exparalel | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Blood Serum Levels of Bupivocaine From Baseline | 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. | Posted | Median | Inter-Quartile Range | ug/cc | Change from baseline at 2 and 5 hours post-dose |
|
Hospital discharge following arthroplasty.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Research Scientist | OrthoCarolina Research Institute | 704-323-2260 | susan.odum@orthocarolina.com |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Charlotte |
| North Carolina |
| 28209 |
| United States |
| OrthoCarolina Research Institute, OrthoCarolina, P.A. | Charlotte | North Carolina | 28209 | United States |
| OrthoCarolina, PA | Charlotte | North Carolina | 28209 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Surgery Performed | Count of Participants | Participants |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |