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EXPAREL Infiltration in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255500
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Brief Summary:
The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee arthroplasty (TKA).

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine FNB Drug: EXPAREL Infiltration Phase 4

Detailed Description:

On Day 1, eligible subjects will receive a single 20 mL dose of bupivacaine hydrochloride (HCl) 0.5% with epinephrine 1:200,000 within 2 hours prior to the surgical procedure as an ultrasound-guided femoral nerve block (FNB). EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site prior to wound closure. There will be no local coadministration of the two drugs.

Blood samples for bupivacaine pharmacokinetic (PK) analysis will be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours after the beginning of EXPAREL administration, and on Day 14.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Pharmacokinetics and Safety of Local Administration of EXPAREL in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Unilateral Total Knee Arthroplasty
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Bupivacaine FNB + EXPAREL Infiltration
FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.
Drug: Bupivacaine FNB
A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.
Other Name: Bupivacaine

Drug: EXPAREL Infiltration
A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.
Other Name: Bupivacaine




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Baseline through Day 14 ]
  2. Time to peak plasma concentration (Tmax) [ Time Frame: Baseline through Day 14 ]
  3. Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration after drug administration (AUC0-last) [ Time Frame: Baseline through Day 14 ]
  4. Area under the plasma concentration versus time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞) [ Time Frame: Baseline through Day 14 ]
  5. The apparent terminal elimination rate constant (λz) [ Time Frame: Baseline through Day 14 ]
  6. The apparent terminal elimination half-life (t1/2el) [ Time Frame: Baseline through Day 14 ]


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
Criteria

Inclusion Criteria:

  1. Males or females ≥18 years of age.
  2. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
  3. Scheduled to undergo femoral nerve block in conjunction with unilateral TKA.
  4. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. Females of childbearing potential must have a documented negative blood or urine pregnancy test result within 24 hours before surgery.
  5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

Exclusion Criteria:

  1. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
  2. Contraindication to bupivacaine.
  3. Received bupivacaine or any other local anesthetic within 7 days of EXPAREL administration.
  4. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration.
  5. Planned concurrent surgical procedure (e.g., bilateral TKA).
  6. Body weight <50 kg (110 pounds) or a body mass index ≥45 kg/m2.
  7. Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure during the subject's participation in this study.
  8. Previous participation in an EXPAREL study.
  9. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  10. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
  11. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.

    In addition, the subject will be ineligible to receive EXPAREL if he or she meets the following criteria during surgery:

  12. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.

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): NCT02255500


Locations
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United States, Texas
Research Concepts, GP, LLC
Houston, Texas, United States, 77054
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: David Leiman, MD Research Concepts, GP, LLC
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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02255500    
Other Study ID Numbers: 402-C-406
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Keywords provided by Pacira Pharmaceuticals, Inc:
Total knee arthroplasty
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents