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Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure. |
|
| Bupivacaine HCl | Active Comparator | The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of liposomal bupivacaine on postoperative pain control | VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control. | The study will last 72 hours after the elective procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of liposomal bupivacaine on opioid use | We will quantify opioid use post-operatively by collecting data on total opioid consumption and time to first use of the opioid post-operatively by the patient | The study will last 72 hours after the elective procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Black, DPM | Contact | 212-570-9300 | alextblack@gmail.com | |
| Sariah Ramoutarpersaud, MD | Contact | 718-869-3517 | sramoutarp@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elliot Hershman, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Eyes Ears and Throat Hospital | Recruiting | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Data will be encrypted using BRMS
|
| Bupivacaine HCl | Drug | Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D000588 |
| Amines |