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Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

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ClinicalTrials.gov Identifier: NCT02276040
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

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
Knee Pain Arthritis Drug: periarticular bupivicaine and liposomal bupivicaine

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.

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Exparel




Primary Outcome Measures :
  1. Change in Blood Serum Levels of Bupivocaine From Baseline [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for total knee replacement
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276040


Locations
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United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28207
Novant Health Charlotte Orthopedic Hospital
Charlotte, North Carolina, United States, 28209
OrthoCarolina Research Institute, OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28209
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28209
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
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Principal Investigator: Bryan Springer, MD Physician
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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02276040    
Other Study ID Numbers: 09-14-13E-9084
First Posted: October 27, 2014    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: July 2017
Keywords provided by OrthoCarolina Research Institute, Inc.:
Arthroplasty
Knee Replacement
Analgesia
pain
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents