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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.
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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 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome 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 |
| Change in worst pain over the first postoperative week | Modified BRIEF Pain Inventory (Q1) | From discharge from PACU through first postoperative week |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Self-reported consumption of Tramadol tablets | From hospital discharge through first postoperative week |
| Change in ability to use foot | Stand with equal weight on both feet, wiggle toes, walk 10 steps |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | B-3600 | Belgium |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005531 | Foot Deformities, Acquired |
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| From discharge from PACU through first postoperative week |
| Change in sleep quality | Duration (h), quality rating (0 - 10) | From discharge from PACU through first postoperative week |
| Change in satisfaction with pain control | With pain control (0 - 10) | From discharge from PACU through first postoperative week |
| Change in sensory response in skin dermatomes | Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes | From premedication through first postoperative week |
| Change in motor response in foot | Plantar flexion, dorsiflexion | From premedication 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 first postoperative week |