Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

NCT02276040 | Completed Results

• 1 other identifier: 09-14-13E-9084
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 4

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.

Conditions

Knee Pain Arthritis

Keywords

Arthroplasty; Knee Replacement; Analgesia; pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Exparel

Participants will receive Exparel (periarticular bupivicaine and liposomal bupivicaine).

Drug: periarticular bupivicaine and liposomal bupivicaine

Interventions

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).

Also known as: Exparel

Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for total knee replacement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (4)

OrthoCarolina, PA

Charlotte, North Carolina, 28207, United States

Location

Novant Health Charlotte Orthopedic Hospital

Charlotte, North Carolina, 28209, United States

Location

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Charlotte, North Carolina, 28209, United States

Location

OrthoCarolina, PA

Charlotte, North Carolina, 28209, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Research Scientist
• Organization: OrthoCarolina Research Institute

susan.odum@orthocarolina.com

704-323-2260

Study Officials

• Bryan Springer, MD

  Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 30, 2017
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-07

Locations

US (4)