Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Knee Pain Arthritis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Novant Health Charlotte Orthopedic Hospital
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina, PA
    • Charlotte, North Carolina, United States, 28209
      • OrthoCarolina, PA
    • Charlotte, North Carolina, United States, 28209
      • OrthoCarolina Research Institute, OrthoCarolina, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for total knee replacement

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Bryan Springer, MD, Physician

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: pain; Arthroplasty; Analgesia; Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 09-14-13E-9084