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Evaluation of the Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Subjects Undergoing for Unilateral Total Knee Arthroplasty
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.
Details
| Lead sponsor | Pacira Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 15 |
| Start date | 2014-12 |
| Completion | 2015-03 |
Conditions
- Pain
Interventions
- Bupivacaine SNB
- EXPAREL Infiltration
Primary outcomes
- Maximum Plasma Concentration (Cmax) — baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
- Time to Peak Plasma Concentration (Tmax) — 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) — 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-∞) — baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
- The Apparent Terminal Elimination Rate Constant (λz) — 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) — baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Countries
United States