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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 for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) |
|
| Group 2 | Experimental | EXPAREL (bupivacaine liposome injectable suspension) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV morphine sulfate or Sponsor-approved equivalent | Drug | Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (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 the discharge order is written or Day 30, whichever is sooner |
| Health Economic Benefits - Total Cost of Hospitalization | 1) 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 is written or Day 30, whichever is sooner. |
| Health Economic Benefit - Length of Stay | Time from completion of wound closure until hospital discharge written or through Day 30, whichever was 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 |
|---|---|---|
| Jorge Marcet, MD | University of South Florida, Tampa, FL | Principal Investigator |
| Valentine Nfonsam, MD | University of Arizona, Tucson, AZ | Principal Investigator |
| Sergio Larach, MD | Florida Hospital, Orlando, FL. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine | Tucson | Arizona | 85724 | United States | ||
| Florida Hospital d/b/a Colon & Rectal Surgery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. |
| FG001 | Group 2 | EXPAREL (bupivacaine liposome injectable suspension) EXPAREL: Patients enrolled 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One patient in Group 1 did not have the planned surgery. Thus, while 16 participants were enrolled in Group 1, 15 participants were in the Safety Analysis Set and had the planned surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. |
| BG001 |
| 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. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Mean | Standard Deviation | mg morphine equivalent | Wound closure to time the discharge order is written or Day 30, whichever is sooner |
|
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The Safety Analysis Set included all patients who underwent the planned surgery. There were 15 participants in Group 1 and 17 participants in Group 2 who underwent the 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 | IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal hemorrhage | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Marcet, MD | University of South Florida | 813-844-4545 | jmarcet@health.usf.edu |
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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 | Drug | Patients enrolled 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. |
|
|
| Patient Satisfaction With Postsurgical Analgesia | Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Patient Discharged From the Hospital for at Least 3 Days | Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Readmission to Hospital Since Discharge | Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Make Unplanned VIsit(s) With Any Healthcare Providers | Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Experienced Any Health Problems or Changed in Health Since Hospital Discharge | Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable. | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
| Orlando |
| Florida |
| 32804 |
| United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Group 2 |
EXPAREL (bupivacaine liposome injectable suspension) EXPAREL: Patients enrolled 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, 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 |
|
| 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) EXPAREL: Patients enrolled 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, 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 | 1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Mean | Standard Deviation | dollars | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| 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. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | events | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Primary | Health Economic Benefit - Length of Stay | Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Median | Full Range | days | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Patient Satisfaction With Postsurgical Analgesia | Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | percentage of patients | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Patient Discharged From the Hospital for at Least 3 Days | Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Readmission to Hospital Since Discharge | Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Make Unplanned VIsit(s) With Any Healthcare Providers | Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| Secondary | Experienced Any Health Problems or Changed in Health Since Hospital Discharge | Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable. | The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL). | Posted | Number | participants | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. |
|
|
|
| 1 |
| 15 |
| 7 |
| 15 |
| EG001 | Group 2 | EXPAREL (bupivacaine liposome injectable suspension) EXPAREL: Patients enrolled 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. | 0 | 17 | 8 | 17 |
| Abdominal pain | Gastrointestinal disorders |
|
| Anal pruritus | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Fecal incontinence | Gastrointestinal disorders |
|
| Frequent bowel movements | Gastrointestinal disorders |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders |
|
| Hematochezia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Pyrexia | General disorders |
|
| Influenza | Infections and infestations |
|
| Anal injury | Injury, poisoning and procedural complications |
|
| Incision site erythema | Injury, poisoning and procedural complications |
|
| Incision site edema | Injury, poisoning and procedural complications |
|
| Incision site pain | Injury, poisoning and procedural complications |
|
| Postoperative ileus | Injury, poisoning and procedural complications |
|
| Sinus headache | Nervous system disorders |
|
| Urinary retention | Renal and urinary disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Incisional drainage | Surgical and medical procedures |
|
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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 |