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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03106545 | Liposome Bupivacaine for ANKLE Blocks | PHASE2 | COMPLETED | 40 | — | — | Jan 2, 2017 | Oct 31, 2017 | Sep 11, 2020 | 1 | Belgium |
Pain rating (NRS) at rest and with movement
Modified BRIEF Pain Inventory (Q1)
| Arm | Type | Description |
|---|---|---|
| Single mixture LB & bupivacaine | EXPERIMENTAL | A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves |
| Bupivacaine alone | ACTIVE_COMPARATOR | Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves |
| General anesthesia | SHAM_COMPARATOR | General anesthesia |
| Name | Type | Description |
|---|---|---|
| Liposome bupivacaine | DRUG | - |
Inclusion Criteria: * Male or female, at least 18 years and max 65 years of age at screening * Scheduled to undergo primary Scarf osteotomy for elective hallux valgus * American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 * Female subject must be surgically sterile or have a monog...