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Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL | Experimental | undiluted EXPAREL 266 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug | single dose 266 mg of undiluted EXPAREL |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Postsurgical Analgesic Use | The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical AEs and SAEs Through Day 30. | Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kronenfeld, MD | Maimonides | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
Subjects were not excluded.
Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL | All subjects received a total of 266mg EXPAREL (bupicavaine liposome injectable suspension) diluted with preservative-free 0.9% normal saline to a volume of 30mL. Study drug was to be administered with ultrasound guidance by injection through a needle or catheter into the tissue plane between the transversus abdominis and internal oblique muscles of the abdominal wall. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL | undiluted EXPAREL 266 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overall Postsurgical Analgesic Use | The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg) | The analysis population comprised all enrolled subjects. | Posted | Mean | Standard Deviation | mg (morphine equivalents) | 10 days |
|
|
Through Day 30
Adverse events were collected by the investigator from the time of signing the informed consent form through 30 days post surgery.
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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 | Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Kronefeld, MD | Maimonides Medical Center | (718) 283-8816 |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Postsurgical AEs and SAEs Through Day 30. | Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL. | The analysis population comprised all enrolled subjects. | Posted | Number | AEs | 30 days |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |