Retraction of ColostomyPhase 4IMPROVE-IRNCT01509638
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
A Phase 4 study testing Group 2 EXPAREL in people with Retraction of Colostomy, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retraction of Colostomy
- What is being tested?
- Group 2 EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Ohio
Beachwood, Ohio, 44122
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal
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.
Read the 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.
- Conditions
- Retraction of Colostomy
- Being tested
- Group 1 Standard of Care, Group 2 EXPAREL
- Keywords
- Ileostomy reversal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Standard of CareDrug
Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
Group 2 EXPARELDrug
Also called bupivacaine liposome injectable suspension
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Standard of Care | Active comparator | IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump Receives: Drug: Group 1 Standard of Care |
| Group 2 EXPAREL | Active comparator | bupivacaine liposome injectable suspension. Receives: Drug: Group 2 EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Burden
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner
Health Economic Benefits
Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
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.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Secondary outcomes (7)
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.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Satisfaction With Postsurgical Analgesia
Responses to one question pertaining to patient satisfaction with postsurgical analgesia
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
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.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
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
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
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.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
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
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Time to First Opioid Administration
Time in hours to first opioid administration
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retraction of ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- Marylise Boutros, M.D., Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509638
- Sponsor's protocol ID
- MA402S23B501
- Acronym
- IMPROVE-IR
- Status last verified
- Jan 2014
- First submitted
- 24 Oct 2011
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.
PubMed 25018650
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal
- ClinicalTrials.gov ID
- NCT01509638
- Acronym / sponsor ID
- IMPROVE-IR / MA402S23B501
- Conditions
- Retraction of Colostomy
- Keywords
- Ileostomy reversal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Standard of Care | Active comparator | Drug: Group 1 Standard of CareIV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump |
| Group 2 EXPAREL | Active comparator | Drug: Group 2 EXPARELbupivacaine liposome injectable suspension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Standard of CarePatients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. | Drug | Group 1 Standard of Care |
| Group 2 EXPARELAlso: bupivacaine liposome injectable suspensionPatients 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. | Drug | Group 2 EXPAREL |
Primary outcome
Total Opioid Burden
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Incidence of Opioid-related Adverse Events
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Satisfaction With Postsurgical Analgesia
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Discharged From Hospital for at Least 3 Days
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Patient Made Unplanned Visit(s) With Any Healthcare Providers
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Experienced Health Problems or Changes in Health Since Hospital Discharge
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Time to First Opioid Administration
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25018650Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylise Boutros, M.D. principal investigator
Cleveland Clinic Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group 2 EXPAREL in people with Retraction of Colostomy, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Burden (time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.