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Sponsor Decision.
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This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Group 1 | Experimental | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. |
|
| Cohort 1, Group 2 | Active Comparator | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety. |
|
| Cohort 2, Group 1 | Experimental | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. |
|
| Cohort 2, Group 2 | Active Comparator | Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 2 will provide measures for efficacy and safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL 13.3Mg/mL Suspension for Injection | Drug | Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of analgesic effect | Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery. | 0 hours to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postsurgical Opioid Consumption | Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery | 0 hours to 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
Previous participation in EXPAREL study
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
Currently pregnant, nursing, or planning to become pregnant during the study
Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
Inadequate sensory function on the foot (monofilament test)
Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
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Double-blind
| Bupivacaine Hydrochloride | Drug | Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL |
|
| ID | Term |
|---|---|
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| D007267 | Injections |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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