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The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL 20 mL (undiluted) | Experimental | 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. |
|
| EXPAREL 40 mL (diluted) | Active Comparator | 20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL 20 mL | Drug | EXPAREL 266 mg (undiluted) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Duration of Abdominal Analgesia From Infiltration Into the TAP | First postsurgical administration of an opioid |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Postsurgical Pain | 11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain) | 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP |
| Physician/Healthcare Professional Assessed Postsurgical Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sternlicht, MD | Steward St. Elizabeth's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steward St. Elizabeth's | Brighton | Massachusetts | 02135 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL 20 mL | Group receiving EXPAREL 20 mL |
| FG001 | EXPAREL 40 mL | Group receiving EXPAREL 40 mL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL 20 mL | Group receiving EXPAREL 20 mL |
| BG001 | EXPAREL 40 mL | Group receiving EXPAREL 40 mL |
| 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 | The Duration of Abdominal Analgesia From Infiltration Into the TAP | Per protocol | Posted | Median | Inter-Quartile Range | hours | First postsurgical administration of an opioid |
|
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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 20 mL | Group receiving EXPAREL 20 mL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-procedural Hematoma | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Sternlicht, MD | St. Elizabeth's Medical Center | 617-789-2777 | andrew.sternlicht@steward.org |
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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 40 mL | Drug | EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL. |
|
|
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
| 1, 2, 6, 12, 24 hours after TAP |
| Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | Number of pills | 48, 72, 96 hours |
| Incidence of Prespecified Opioid-related Adverse Events | Number of subjects | Until hospital discharge order was written, anticipated at 24 hours. |
| Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied) | 24 hours, 72 hours, and day 10 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Subject Reported Postsurgical Pain | 11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain) | Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment. | Posted | Mean | Standard Deviation | units on a scale | 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP |
|
|
|
| Secondary | Physician/Healthcare Professional Assessed Postsurgical Pain | 11-point NRS (0-10, 0=no pain, 10=worst possible pain) | Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment. | Posted | Mean | Standard Deviation | units on a scale | 1, 2, 6, 12, 24 hours after TAP |
|
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| Secondary | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | Number of pills | Posted | Mean | Standard Deviation | Number of tablets | 48, 72, 96 hours |
|
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| Secondary | Incidence of Prespecified Opioid-related Adverse Events | Number of subjects | Posted | Number | Number of subjects | Until hospital discharge order was written, anticipated at 24 hours. |
|
|
|
| Secondary | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied) | Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment. | Posted | Count of Participants | Participants | 24 hours, 72 hours, and day 10 |
|
|
|
| 3 |
| 12 |
| 0 |
| 12 |
| EG001 | EXPAREL 40 mL | Group receiving EXPAREL 40 mL | 0 | 12 | 1 | 12 |
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| 2 hours after TAP |
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| 6 hours after TAP |
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| 12 hours after TAP |
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| 24 hours after TAP |
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| 48 hours after TAP |
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| 72 hours after TAP |
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| 96 hours after TAP |
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| Day 10 after TAP |
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| 2 hours after TAP |
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| 6 hours after TAP |
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| 12 hours after TAP |
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| 24 hours after TAP |
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| 96 hours |
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| 24 hours- extremely satisfied |
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| 72 hours - satisfied |
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| 72 hours - extremely satisfied |
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| Day 10 - satisfied |
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| Day 10- extremely satisfied |
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