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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 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 injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Standard of Care | Active Comparator | IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump |
|
| Group 2 EXPAREL | Active Comparator | bupivacaine liposome injectable suspension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 Standard of Care | Drug | Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Burden | Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner |
| Health Economic Benefits | Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Health Economic Benefit | Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Opioid-related Adverse Events | Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. | Wound closure to time hospital discharge order is written or Day 30, whichever 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 |
|---|---|---|
| Marylise Boutros, M.D. | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| Cleveland Clinic Ohio |
| 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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23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Standard of Care | IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. |
| FG001 | Group 2 EXPAREL | bupivacaine liposome injectable suspension. Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Standard of Care | IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. |
| BG001 | Group 2 EXPAREL |
| 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 hospital discharge order is written or through Day 30, whichever is sooner. | 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Mean | Standard Deviation | mg morphine equivalent | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner |
|
30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
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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 | Group 1 Standard of Care | IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marylise Boutrous, MD | Cleveland Clinic Florida | 954-659-5000 | canedoj@ccf.org |
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| Group 2 EXPAREL | Drug | Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
|
|
| Patient Satisfaction With Postsurgical Analgesia | Responses to one question pertaining to patient satisfaction with postsurgical analgesia | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Patient Discharged From Hospital for at Least 3 Days | Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Patient Made Unplanned Visit(s) With Any Healthcare Providers | Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Experienced Health Problems or Changes in Health Since Hospital Discharge | Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Time to First Opioid Administration | Time in hours to first opioid administration | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Beachwood |
| Ohio |
| 44122 |
| United States |
bupivacaine liposome injectable suspension. Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2 EXPAREL | bupivacaine liposome injectable suspension. Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
|
|
| Primary | Health Economic Benefits | Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner. | 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Mean | Standard Deviation | dollars | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Primary | Health Economic Benefit | Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner. | 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Median | Full Range | days | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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|
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| Secondary | Incidence of Opioid-related Adverse Events | Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. | 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Mean | Standard Deviation | number of events | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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|
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| Secondary | Patient Satisfaction With Postsurgical Analgesia | Responses to one question pertaining to patient satisfaction with postsurgical analgesia | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
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| Secondary | Patient Discharged From Hospital for at Least 3 Days | Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable. | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
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| Secondary | Patient Made Unplanned Visit(s) With Any Healthcare Providers | Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Number | participants who answered yes | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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| Secondary | Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable. | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Number | participants who answered yes | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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| Secondary | Experienced Health Problems or Changes in Health Since Hospital Discharge | Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Number | participants who answered yes | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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| Secondary | Time to First Opioid Administration | Time in hours to first opioid administration | Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL) | Posted | Median | Full Range | hours | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
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| 0 |
| 22 |
| 18 |
| 22 |
| EG001 | Group 2 EXPAREL | bupivacaine liposome injectable suspension. Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. | 3 | 25 | 15 | 25 |
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Systemic inflammatory response syndrome | Immune system disorders | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
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| Anastomatic complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
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| Pyoderma gangrinosum | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Edema peripheral | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Postprocedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoesthesia | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Neither Satisfied nor Dissatisfied |
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| Dissatisfied |
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| Not Reported |
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