Bowel Obstruction
Conditions
Keywords
open colectomy
Brief summary
This study is designed to compare the standard of care against EXPAREL(R) 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 compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.
Interventions
Patients in this group will receive IV morphine sulfate 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.
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
FACTORIAL
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 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 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. * Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery In addition, the patient will be ineligible if he/she meets the following criteria during surgery: * Patients who have any concurrent surgical procedure. * Patients with unplanned multiple segmental resections or 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 an 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 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 Benefits - Total Cost of Hospitalization | Wound closure to time hospital discharge order written or Day 30, whichever is sooner. | Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. |
| Health Economic Benefits - Length of Stay | Up to Day 30 | Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, 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 Predefined 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), which ever is sooner | The incidence of predefined opioid-related adverse events |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment Dec 13, 2011 to July 3, 2012
Pre-assignment details
open-label, sequential study with two treatment groups. Patients were to be excluded if they met certain intraoperative exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| PCA/Opioid Group Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed. | 20 |
| EXPAREL Group Group receiving EXPAREL | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Required different surgical procedures | 2 | 1 |
Baseline characteristics
| Characteristic | EXPAREL Group | PCA/Opioid Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 15 Participants | 32 Participants |
| Age Continuous | 52.6 years STANDARD_DEVIATION 17.51 | 54.1 years STANDARD_DEVIATION 15.77 | 53.3 years STANDARD_DEVIATION 16.53 |
| Region of Enrollment United States | 22 participants | 20 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 18 | 7 / 21 |
| serious Total, serious adverse events | 4 / 18 | 5 / 21 |
Outcome results
Primary
Health Economic Benefits - Length of Stay
Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, 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: Up to Day 30
Population: All subjects analyzed, no censored events
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PCA/Opioid Group | Health Economic Benefits - Length of Stay | 4.9 days |
| EXPAREL | Health Economic Benefits - Length of Stay | 2.0 days |
Primary
Health Economic Benefits - Total Cost of Hospitalization
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 written or Day 30, whichever is sooner.
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA/Opioid Group | Health Economic Benefits - Total Cost of Hospitalization | 11850.28 dollars | Standard Deviation 6600.9 |
| EXPAREL | Health Economic Benefits - Total Cost of Hospitalization | 8766.07 dollars | Standard Deviation 1048.95 |
Comparison: Null hypothesis = distribution of costs is identical between the two groups.p-value: 0.0276795% CI: [1.03, 1.49]least-squares mean ratio
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: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA/Opioid Group | Total Opioid Burden | 115.00 mg | Standard Deviation 113.27 |
| EXPAREL | Total Opioid Burden | 56.76 mg | Standard Deviation 74.04 |
Comparison: Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.p-value: 0.025195% CI: [1.14, 6.03]least-squares mean ratio
Secondary
Incidence of Predefined Opioid-related Adverse Events
The incidence of predefined opioid-related adverse events
Time frame: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner
Population: Per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCA/Opioid Group | Incidence of Predefined Opioid-related Adverse Events | 0 Number of patients |
| EXPAREL | Incidence of Predefined Opioid-related Adverse Events | 0 Number of patients |