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Slow enrollment.
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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 (bupivacaine liposome extended-release injectable suspension) 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 (bupivacaine liposome extended-release injectable suspension), compared with postsurgical administration of standardized intravenous (IV) morphine sulfate, 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 | morphine sulfate (or Sponsor-approved equivalent) |
|
| EXPAREL | Experimental | EXPAREL (bupivacaine liposome injectable suspension) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV morphine sulfate | Drug | Patients in this group will receive IV morphine sulfate via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 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 |
| Wound closure to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia. |
|
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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 |
|---|---|---|
| Keith Candiotti, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Dept of Anesthesiology | Miami | Florida | 33136 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | IV Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: 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. |
| FG001 | EXPAREL | EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): 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, a 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: 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. |
| 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 | Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner. | As no subjects received EXPAREL in this study, statistical analyses were not performed. | Posted | Wound closure to time hospital discharge order written or Day 30, whichever is sooner |
|
30 days post surgery
normal systematic assessment of 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 | IV Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Candiotti, MD | University of Miama/Jackson Memorial Hospital | 305-585-5332 | info@jhsmiami.org |
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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, a 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. |
|
|
| Wound closure to time hospital discharge order written or Day 30, whichever is sooner. |
| BG001 |
| EXPAREL |
EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): 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, a 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 |
| years |
|
| Age, Categorical | Number | participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): 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, a 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. |
|
| Primary | Health Economic Benefits |
| As no subjects received EXPAREL in this study, statistical analyses were not performed. | Posted | Wound closure to Day 30 |
|
|
| Secondary | Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia. |
| As no subjects received EXPAREL in this study, statistical analyses were not performed. | Posted | Wound closure to time hospital discharge order written or Day 30, whichever is sooner. |
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | EXPAREL | EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): 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, a 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. | 0 | 0 | 0 | 0 |
| Mesenteric vein thrombosis | Gastrointestinal disorders | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Urine output decreased | Investigations | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hyperthermia | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anemia post-operative | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | 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 |