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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with less pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single mixture LB & bupivacaine | Experimental | A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the median and ulnar nerves |
|
| Bupivacaine alone | Active Comparator | Bupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome bupivacaine + bupivacaine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in current pain over the first postoperative week | Pain rating (NRS) at rest and with movement | From baseline (before nerve block) through first postoperative week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in worst pain over the first postoperative week | Modified BRIEF Pain Inventory (Q1) | From discharge from hospital through first postoperative week |
| Change in ability to use hand | Hold Styrofoam cup |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of participants with side effects to regional anesthesia peripheral nerve blockade | Nausea, vomiting, fever, constipation, severe itching of the skin, dizziness, sleepless nights, excessive sweating, urinary retention, headache, heart palpitations | From beginning of nerve block through first postoperative week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Admir Hadzic, MD, PhD | Ziekenhuis Oost-Limburg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | B-3600 | Belgium |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| From discharge from hospital through first postoperative week |
| Change in sleep quality | Duration (h), quality rating (0 - 10) | From discharge from hospital through first postoperative week |
| Change in satisfaction with pain control | With pain control (0 - 10) | From discharge from hospital through first postoperative week |
| Change in sensory response in skin dermatomes | Cold, pinprick, light touch in the medial and ulnar nerve dermatomes | From beginning of nerve block through first postoperative week |
| Change in motor response in thumb and fingers | Abduction/adduction thumb/fingers | From beginning of nerve block through first postoperative week |
| Participants with adverse events |
Any untoward medical occurrence (unfavorable and/or unintended change in a body structure or body function) associated with the use of a drug in humans, whether or not considered drug related |
| From date of signing ICF through the first postoperative week |
| D000588 |
| Amines |