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| Name | Class |
|---|---|
| Registrat-Mapi | OTHER |
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This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV morphine sulfate | Active Comparator | Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. |
|
| EXPAREL (bupivacaine liposome injectable suspension) | Experimental | EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV morphine sulfate | Drug | Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order written or Day 30, whichever is sooner |
| Health Economic Benefits - Total Cost of Hospitalization | Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order written or Day 30, whichever is sooner. |
| Health Economic Benefits - Length of Stay | Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner. | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Predefined Opioid-related Adverse Events | The incidence of predefined opioid-related adverse events | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cohen, M.D. | Atlanta Colon and Rectal Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Colon and Rectal Surgery | Riverdale | Georgia | 30274 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25018650 | Derived | Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014. |
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open-label, sequential study with two treatment groups. Patients were to be excluded if they met certain intraoperative exclusion criteria.
Dates of recruitment Dec 13, 2011 to July 3, 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | PCA/Opioid Group | Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed. |
| FG001 | EXPAREL Group | Group receiving EXPAREL |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCA/Opioid Group | Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed. |
| BG001 | EXPAREL Group | Group receiving EXPAREL |
| 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 | Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner. | Per protocol | Posted | Mean | Standard Deviation | mg | Wound closure to time hospital discharge order written or Day 30, whichever is sooner |
|
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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 | PCA/Opioid Group | Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Cohen, MD | Atlanta Colon and Rectal Surgery | 770-997-1975 | klong@atlantacolon.com |
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| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| EXPAREL (bupivacaine liposome injectable suspension) | Drug | Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed. |
|
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Health Economic Benefits - Total Cost of Hospitalization | Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. | per protocol | Posted | Mean | Standard Deviation | dollars | Wound closure to time hospital discharge order written or Day 30, whichever is sooner. |
|
|
|
|
| Secondary | Incidence of Predefined Opioid-related Adverse Events | The incidence of predefined opioid-related adverse events | Per protocol. | Posted | Number | Number of patients | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner |
|
|
|
| Primary | Health Economic Benefits - Length of Stay | Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner. | All subjects analyzed, no censored events | Posted | Median | Inter-Quartile Range | days | Up to Day 30 |
|
|
|
| 4 |
| 18 |
| 4 |
| 18 |
| EG001 | EXPAREL Group | Group receiving EXPAREL | 5 | 21 | 7 | 21 |
| Wound evisceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Drug Seeking Behavior | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Post Procedural Hematoma | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Wound Evisceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Blood Creatine Increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Therapy Regimen Changed | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Wound Drainage | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |