Bowel Obstruction
Conditions
Keywords
open colectomy
Brief summary
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.
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 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.
Interventions
DRUGmorphine sulfate
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.
DRUGbupivacaine 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.
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 open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. * Ability to provide informed consent, adhere to study visit schedule, and complete all study 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. * 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 a EXPAREL study within the last 30 days. * Patients who have received any 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 or she meets the following criteria during surgery: * Patients with unplanned multiple segmental resections of large intestine. * Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed. * 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). * Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Burden | Wound closure to time hospital discharge order written or Day 30, whichever is sooner | Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner. |
| Health Economic Benefit | Wound closure to time hospital discharge order written or Day 30, whichever is sooner. | 1. Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner. 2. 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 |
|---|---|---|
| Incidence of Opioid-related 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 | 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. . |
| Patient Satisfaction With Postsurgical Analgesia | 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 | Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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 |
| Total | 2 |
Baseline characteristics
| Characteristic | Morphine Sulfate | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 2 participants | 2 participants |
| Age, Continuous | 51.5 years STANDARD_DEVIATION 12.02 | 51.5 years STANDARD_DEVIATION 12.02 |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 1 participants | 1 participants |
| Region of Enrollment United States | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Health Economic Benefit
1. Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner. 2. 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 written or Day 30, whichever is sooner.
Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.
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.
Time frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner
Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.
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. .
Time frame: 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
Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Morphine Sulfate | Incidence of Opioid-related Adverse Events | 10 Adverse events |
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.
Time frame: 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
Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.