Phase 4
Completed N=15
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
Source: ClinicalTrials.gov NCT02284386 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 408 ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
408 | — |
| PRIMARY Time to Peak Plasma Concentration (Tmax) |
12.0 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last) |
15286 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞) |
13741 | — |
| PRIMARY The Apparent Terminal Elimination Rate Constant (λz) |
0.0523 | — |
| PRIMARY The Apparent Terminal Elimination Half-life (t1/2el) |
14.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02284386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.