Status:
COMPLETED
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total k...
Detailed Description
On Day 1, following an epinephrine "wash" of the spinal block syringe, eligible subjects will receive a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure a...
Eligibility Criteria
Inclusion
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo spinal block in conjunction with unilateral TKA.
- 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.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Exclusion
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine.
- Received bupivacaine or any other local anesthetic within 7 days of EXPAREL administration.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Body weight \<50 kg (110 pounds) or a body mass index ≥45 kg/m2.
- 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.
- Previous participation in an EXPAREL study.
- 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.
- 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.
- 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:
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02284386
Start Date
December 1 2014
End Date
March 1 2015
Last Update
March 8 2021
Active Locations (2)
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1
Shaols Medical Trials, Inc.
Sheffield, Alabama, United States, 35660
2
University of Minnesota Medical Center - Fairview, West Bank
Minneapolis, Minnesota, United States, 55455