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Lack of enrollment
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The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL Group 1 | Experimental | EXPAREL 266 mg diluted with saline to a volume of 40 mL |
|
| EXPAREL Group 2 | Experimental | EXPAREL 266 mg diluted with saline to a volume of 60 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug | Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 10 days post surgery plus or minus 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Dorian, MD | St. Barnabas Medical Center, Livingston, NJ 07039 | Principal Investigator |
| Thad Denehy, MD | St. Barnabas Medical Center, Livingston, NJ 07039 | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL Group 1 | EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. |
| FG001 | EXPAREL Group 2 | EXPAREL 266 mg diluted with saline to a volume of 60 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL Group 1 | EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. |
| BG001 | EXPAREL Group 2 |
| 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 | Duration of Analgesia | Posted | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) |
|
10 days post surgery plus or minus 3 days
Normal systematic assessment for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EXPAREL Group 1 | EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pacira Medical Information | Pacira Pharmaceuticals, Inc. | 1-855-793-9727 | MedInfo@pacira.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Incidence of Adverse Events | Posted | Number | number of events | 10 days post surgery plus or minus 3 days |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | EXPAREL Group 2 | EXPAREL 266 mg diluted with saline to a volume of 60 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. | 0 | 0 | 0 | 0 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |