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 for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.
Interventions
Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
DRUGEXPAREL
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.
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 and 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 lest 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 the 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 - Total Cost of Hospitalization | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 1\) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. |
| Health Economic Benefit - Length of Stay | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission to Hospital Since Discharge | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate. |
| Make 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 an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; 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. |
| Experienced Any Health Problems or Changed in Health Since Hospital Discharge | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 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. |
| Contact or Attempt 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 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. |
| Patient Satisfaction With Postsurgical Analgesia | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied. |
| Patient Discharged From the Hospital for at Least 3 Days | Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 17 |
| Total | 32 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Continuous | 55.7 years STANDARD_DEVIATION 16.03 | 52.1 years STANDARD_DEVIATION 15.89 | 53.8 years STANDARD_DEVIATION 15.8 |
| Region of Enrollment United States | 15 participants | 17 participants | 32 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 15 | 8 / 17 |
| serious Total, serious adverse events | 1 / 15 | 0 / 17 |
Outcome results
Primary
Health Economic Benefit - Length of Stay
Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Health Economic Benefit - Length of Stay | 5.1 days |
| Group 2 | Health Economic Benefit - Length of Stay | 3 days |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Health Economic Benefits - Total Cost of Hospitalization | 9950.47 dollars | Standard Deviation 3899.04 |
| Group 2 | Health Economic Benefits - Total Cost of Hospitalization | 6728.88 dollars | Standard Deviation 1874.89 |
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 the discharge order is written or Day 30, whichever is sooner
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Total Opioid Burden | 112.38 mg morphine equivalent | Standard Deviation 117.08 |
| Group 2 | Total Opioid Burden | 19.8 mg morphine equivalent | Standard Deviation 34.08 |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery | 1 participants |
| Group 2 | Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery | 0 participants |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Experienced Any Health Problems or Changed in Health Since Hospital Discharge | 1 participants |
| Group 2 | Experienced Any Health Problems or Changed in Health Since Hospital Discharge | 2 participants |
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: 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).
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1 | Incidence of Opioid-related Adverse Events | 6 events | 0.82 |
| Group 2 | Incidence of Opioid-related Adverse Events | 4 events | 0.45 |
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
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Make Unplanned VIsit(s) With Any Healthcare Providers | 1 participants |
| Group 2 | Make Unplanned VIsit(s) With Any Healthcare Providers | 0 participants |
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
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Patient Discharged From the Hospital for at Least 3 Days | 11 participants |
| Group 2 | Patient Discharged From the Hospital for at Least 3 Days | 14 participants |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1 | Patient Satisfaction With Postsurgical Analgesia | 90.91 percentage of patients | 0.65 |
| Group 2 | Patient Satisfaction With Postsurgical Analgesia | 87.5 percentage of patients | 0.83 |
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.
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Readmission to Hospital Since Discharge | 0 participants |
| Group 2 | Readmission to Hospital Since Discharge | 0 participants |