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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

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date March 20, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Maximum plasma concentration (Cmax) [ Time Frame: Baseline through Day 14 ]
  • Time to peak plasma concentration (Tmax) [ Time Frame: Baseline through Day 14 ]
  • 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 ]
  • Area under the plasma concentration versus time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞) [ Time Frame: Baseline through Day 14 ]
  • The apparent terminal elimination rate constant (λz) [ Time Frame: Baseline through Day 14 ]
  • The apparent terminal elimination half-life (t1/2el) [ Time Frame: Baseline through Day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EXPAREL Infiltration in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Total Knee Arthroplasty
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Bupivacaine FNB
  • Drug: EXPAREL Infiltration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
15
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255500
Other Study ID Numbers  ICMJE 402-C-406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pacira Pharmaceuticals, Inc
Study Sponsor  ICMJE Pacira Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Leiman, MD Research Concepts, GP, LLC
PRS Account Pacira Pharmaceuticals, Inc
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP