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Due to reasons unrelated to safety; primary endpoint signal seen during pre-specified interim analysis.
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The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL | Active Comparator | EXPAREL (266mg/20 ml) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP |
|
| Placebo | Sham Comparator | The placebo control will be established using a grade-2 sham, no infiltration will occur |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug | TAP with EXPAREL |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 | Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4 | From surgery through 4 days postsurgery |
| Overall Benefit of Analgesic Score (OBAS) at Day 3 | Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain) | Postsurgical day 1 through day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Extent and Degree of Anesthetic Blockade | Extent and degree of anesthetic blockage measured using a 5-point sensation scale. | Prior to TAP, immediately postoperatively, and daily through discharge or Day 4 |
| Severity of Postsurgical Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kay Warnott, RN | Pacira Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Winter Park | Florida | 32792 | United States | ||
| Memorial Health University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL | EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
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Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).
| Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4) |
| Quality of Recovery | Measured using the Quality of Recovery 15 questionnaire (QoR-15) | Daily through Post Op Day 4 |
| Frequency of Patient Calls Post-discharge | Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits | Post-discharge through 4 days postsurgery |
| Savannah |
| Georgia |
| 31404 |
| United States |
| Northwestern University | Chicago | Illinois | 60208 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Berkshire Medical Center | Pittsfield | Massachusetts | 01210 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC St. Margaret's Hospital | Pittsburgh | Pennsylvania | 15215 | United States |
| St. John Hospital | Houston | Texas | 77081 | United States |
The placebo control was established using a grade-2 sham; no infiltration occurred.
Placebo
| COMPLETED |
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| NOT COMPLETED |
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Who met eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL | EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL |
| BG001 | Placebo | The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 | Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4 | Posted | Mean | Standard Error | Opioid consumption (mg) | From surgery through 4 days postsurgery |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Benefit of Analgesic Score (OBAS) at Day 3 | Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain) | Posted | Least Squares Mean | Standard Error | units on a scale | Postsurgical day 1 through day 3 |
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| Secondary | Extent and Degree of Anesthetic Blockade | Extent and degree of anesthetic blockage measured using a 5-point sensation scale. | The analysis was not conducted due to the early termination of this study. | Posted | Prior to TAP, immediately postoperatively, and daily through discharge or Day 4 |
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| Secondary | Severity of Postsurgical Pain | Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10). | The analysis was not conducted due to the early termination of this study. | Posted | Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4) |
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| Secondary | Quality of Recovery | Measured using the Quality of Recovery 15 questionnaire (QoR-15) | The analysis was not conducted due to the early termination of this study. | Posted | Daily through Post Op Day 4 |
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| Secondary | Frequency of Patient Calls Post-discharge | Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits | The analysis was not conducted due to the early termination of this study. | Posted | Post-discharge through 4 days postsurgery |
|
|
10 days
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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 | EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL | 1 | 33 | 0 | 33 | ||
| EG001 | Placebo | The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo | 1 | 34 | 0 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative anemia exacerbation | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Subtherapeutic international normalized ration (INR) | Investigations | MedDRA | Non-systematic Assessment |
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| Postoperative abdominal hemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paci | Pacira Pharmaceuticals, Inc. | 1-855-793-9727 | MedInfo@pacira.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
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| Male |
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