Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04518462 | Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries | PHASE3 | COMPLETED | 121 | — | — | Oct 20, 2020 | Apr 5, 2021 | Jul 18, 2022 | 5 | United States |
To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries. Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl
| Arm | Type | Description |
|---|---|---|
| EXPAREL arm | EXPERIMENTAL | Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline |
| EXPAREL admix arm | EXPERIMENTAL | subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl. |
| Bupivacaine HCl Arm | ACTIVE_COMPARATOR | subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl. |
| Name | Type | Description |
|---|---|---|
| Exparel | DRUG | EXPAREL (bupivacaine liposome injectable suspension) |
| Bupivacaine Hydrochloride | DRUG | 0.25% bupivacaine |
Inclusion Criteria: 1. Healthy adult male or female volunteers ages 18 or older 2. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 4. Body Mass Index (BMI) ≥18 and ≤40 kg/m2 ...