Not provided
Not provided
Not provided
Not provided
Not provided
PI leaving instutition
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel forearm block | Experimental | Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
|
| Bupivacaine supraclavicular block | Active Comparator | Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel Forearm block | Drug | 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Sensorimotor Block | A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted. | 30 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jose Soberon, MD | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exparel Forearm Block | Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
| FG001 | Bupivacaine Supraclavicular Block | Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exparel Forearm Block | Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Onset of Sensorimotor Block | A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted. | Discrepancies are due to a subset of subjects not achieving full blockade at 30 minutes. | Posted | Number | proportion of subjects | 30 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exparel Forearm Block | Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Bode | Ochsner Health System | 504.842.1936 | ken.bode@ochsner.org |
Not provided
| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D014954 | Wrist Injuries |
| D005383 | Finger Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001134 | Arm Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine supraclavicular block | Drug | 20-30mL 0.5% bupivacaine |
|
| BG001 |
| Bupivacaine Supraclavicular Block |
Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Bupivacaine Supraclavicular Block | Under ultrasound guidance, 20-30 milliliters (mL) 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Bupivacaine Supraclavicular Block | Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine | 0 | 21 | 0 | 21 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |