- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02284386
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
Evaluation of the Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Subjects Undergoing for Unilateral Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 as a spinal block. EXPAREL 266 mg in 20 mL (expanded with 70 mL of preservative-free sterile normal saline to a total volume of 90 mL) will be infiltrated into the surgical site at the end of the surgery prior to wound closure. There will be no local co-administration of the two drugs.
Blood samples for bupivacaine 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, and 72 hours after the beginning of EXPAREL administration, and on Day 14.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Alabama
-
Sheffield, Alabama, United States, 35660
- Shaols Medical Trials, Inc.
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center - Fairview, West Bank
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bupivacaine SNB + EXPAREL Infiltration
Spinal block with bupivacaine HCl 7.5 mg/mL.
Local infiltration of EXPAREL 266 mg.
|
SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
Other Names:
Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
Time to Peak Plasma Concentration (Tmax)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
The Apparent Terminal Elimination Rate Constant (λz)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
The Apparent Terminal Elimination Half-life (t1/2el)
Time Frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacob Hutchins, MD, University of Minnesoty
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 402-C-405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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