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This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine injection (Group 1) | Experimental | Liposomal bupivacaine 266 mg via injection |
|
| Bupivacaine HCl continuous infusion (Group 2) | Experimental | Bupivacaine HCl 300 mg via continuous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome injectable suspension | Drug | Liposomal bupivacaine 266 mg via injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total postoperative opioid consumption (in morphine equivalents) | 72 hours | |
| Proportion of subjects who are opioid-free | 72 hours | |
| Median time in hours to first opioid rescue medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine HCl without epinephrine via continuous infusion | Drug | Bupivacaine HCl 300 mg via continuous infusion |
|
| 72 hours |
| Mean AUC0-72 of the NRS-R pain intensity scores. | 72 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000588 |
| Amines |