Retraction of Colostomy
Conditions
Keywords
Ileostomy reversal
Brief summary
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.
Detailed description
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.
Interventions
DRUGGroup 1 Standard of Care
Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
DRUGGroup 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.
Sponsors
Registrat-Mapi
Pacira Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 years of age or older. * Patients scheduled to undergo ileostomy reversal. * Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.
Exclusion criteria
* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol. * Patients who abuse alcohol or other drug substance. * Patients with severe hepatic impairment. * Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing. * Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study. * Patients who have participated in an EXPAREL study within the last 30 days. * Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study. In addition, the patient will be ineligible if he/she meets the following criteria during surgery: * Patients who have any concurrent surgical procedure. * Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents. * Patients who receive Entereg(R).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Burden | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner | Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner. |
| Health Economic Benefits | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner. |
| Health Economic Benefit | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Made Unplanned Visit(s) With Any Healthcare Providers | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable |
| Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable. |
| Incidence of Opioid-related Adverse Events | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 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. |
| Time to First Opioid Administration | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Time in hours to first opioid administration |
| Experienced Health Problems or Changes in Health Since Hospital Discharge | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable |
| Patient Satisfaction With Postsurgical Analgesia | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Responses to one question pertaining to patient satisfaction with postsurgical analgesia |
| Patient Discharged From Hospital for at Least 3 Days | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 25 |
| Total | 47 |
Baseline characteristics
| Characteristic | Group 1 Standard of Care | Group 2 EXPAREL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 24 Participants | 42 Participants |
| Age, Continuous | 47.1 years STANDARD_DEVIATION 17.87 | 48.2 years STANDARD_DEVIATION 14.53 | 47.7 years STANDARD_DEVIATION 16.01 |
| Region of Enrollment United States | 22 participants | 25 participants | 47 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 22 | 15 / 25 |
| serious Total, serious adverse events | 0 / 22 | 3 / 25 |
Outcome results
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Standard of Care | Health Economic Benefit | 4 days |
| Group 2 EXPAREL | Health Economic Benefit | 3 days |
Primary
Health Economic Benefits
Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Standard of Care | Health Economic Benefits | 7284.63 dollars | Standard Deviation 3577.42 |
| Group 2 EXPAREL | Health Economic Benefits | 7010.16 dollars | Standard Deviation 2709.56 |
Primary
Total Opioid Burden
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Standard of Care | Total Opioid Burden | 67.7 mg morphine equivalent | Standard Deviation 46.64 |
| Group 2 EXPAREL | Total Opioid Burden | 38.41 mg morphine equivalent | Standard Deviation 45.85 |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Standard of Care | Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery | 5 participants who answered yes |
| Group 2 EXPAREL | Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery | 2 participants who answered yes |
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
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Standard of Care | Experienced Health Problems or Changes in Health Since Hospital Discharge | 4 participants who answered yes |
| Group 2 EXPAREL | Experienced Health Problems or Changes in Health Since Hospital Discharge | 5 participants who answered yes |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Standard of Care | Incidence of Opioid-related Adverse Events | 0.1 number of events | Standard Deviation 0.22 |
| Group 2 EXPAREL | Incidence of Opioid-related Adverse Events | 0.1 number of events | Standard Deviation 0.29 |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Standard of Care | Patient Discharged From Hospital for at Least 3 Days | 16 participants |
| Group 2 EXPAREL | Patient Discharged From Hospital for at Least 3 Days | 22 participants |
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
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Standard of Care | Patient Made Unplanned Visit(s) With Any Healthcare Providers | 2 participants who answered yes |
| Group 2 EXPAREL | Patient Made Unplanned Visit(s) With Any Healthcare Providers | 4 participants who answered yes |
Secondary
Patient Satisfaction With Postsurgical Analgesia
Responses to one question pertaining to patient satisfaction with postsurgical analgesia
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Standard of Care | Patient Satisfaction With Postsurgical Analgesia | Satisified | 7 participants |
| Group 1 Standard of Care | Patient Satisfaction With Postsurgical Analgesia | Dissatisfied | 0 participants |
| Group 1 Standard of Care | Patient Satisfaction With Postsurgical Analgesia | Neither Satisfied nor Dissatisfied | 1 participants |
| Group 1 Standard of Care | Patient Satisfaction With Postsurgical Analgesia | Not Reported | 4 participants |
| Group 1 Standard of Care | Patient Satisfaction With Postsurgical Analgesia | Extremely Satisfied | 8 participants |
| Group 2 EXPAREL | Patient Satisfaction With Postsurgical Analgesia | Not Reported | 0 participants |
| Group 2 EXPAREL | Patient Satisfaction With Postsurgical Analgesia | Extremely Satisfied | 11 participants |
| Group 2 EXPAREL | Patient Satisfaction With Postsurgical Analgesia | Satisified | 9 participants |
| Group 2 EXPAREL | Patient Satisfaction With Postsurgical Analgesia | Neither Satisfied nor Dissatisfied | 2 participants |
| Group 2 EXPAREL | Patient Satisfaction With Postsurgical Analgesia | Dissatisfied | 1 participants |
Secondary
Time to First Opioid Administration
Time in hours to first opioid administration
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Standard of Care | Time to First Opioid Administration | 0.7 hours |
| Group 2 EXPAREL | Time to First Opioid Administration | 1.1 hours |