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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 |
|---|---|---|---|
| Morphine sulfate | Active Comparator | morphine sulfate (or Sponsor-approved equivalent) |
|
| EXPAREL | Experimental | EXPAREL (bupivacaine liposome extended-release injectable suspension) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine sulfate | Drug | Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump. |
| 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 Benefit |
| Wound closure to time hospital discharge order written or Day 30, whichever is sooner. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Opioid-related Adverse Events | Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. . | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
In addition, the patient will be ineligible if he or she meets the following criteria during surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Bergese, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | 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 | Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump. |
| FG001 | EXPAREL | EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump. |
| 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 after 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 | Morphine Sulfate | morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergio Bergese, MD | The Ohio State University | (614) 293-9027 | bergese.1@osu.edu |
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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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|
|
| bupivacaine liposome extended-release 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. |
|
|
| Patient Satisfaction With Postsurgical Analgesia | Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge. | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner |
| BG001 | EXPAREL | EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 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 |
| years |
|
| Age, Categorical | Number | participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| EXPAREL |
EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 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. |
|
| Primary | Health Economic Benefit |
| 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. |
|
|
| Secondary | Incidence of Opioid-related Adverse Events | Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. . | As no subjects received EXPAREL in this study, statistical analyses were not performed. | Posted | Number | Adverse events | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner |
|
|
|
| Secondary | Patient Satisfaction With Postsurgical Analgesia | Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge. | As no subjects received EXPAREL in this study, statistical analyses were not performed. | Posted | From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | EXPAREL | EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 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. | 0 | 0 | 0 | 0 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | Systematic Assessment |
|
| Tachycardia | Cardiac 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 |