Bowel ObstructionPhase 4IMPROVE-LapNCT02058290
A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy
A Phase 4 study testing IV morphine sulfate or Sponsor-approved equivalent and EXPAREL in people with Bowel Obstruction, run by Pacira Pharmaceuticals, Inc at 6 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 hospital costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Obstruction
- What is being tested?
- IV morphine sulfate or Sponsor-approved equivalent and EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2011to Feb 2013
- 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, at least 18 years of age.
- Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
- Ability to provide informed consent, adhere to study visit schedule, and complete all study 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 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
- Participation in an EXPAREL study within the last 30 days.
Show all 14Show fewer
- 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, a patient was ineligible if he or she met the following criteria during surgery:
- Patients who had any concurrent surgical procedure.
- Patients with unplanned multiple segmental resections of large intestine.
- Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
- Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
- Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
- Patients who received Entereg.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albany Medical College
Albany, New York, 12208
The Ohio State University Medical Center
Columbus, Ohio, 43210
Methodist Hospital
Houston, Texas, 77030
University of Miami, Dept. Anesthesiology
Miami, Florida, 33136
Tampa General Hospital
Tampa, Florida, 33606
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
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 hospital 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 laparoscopic colectomy with general anesthesia.
- Conditions
- Bowel Obstruction
- Being tested
- IV morphine sulfate or Sponsor-approved equivalent, EXPAREL
- Keywords
- laparoscopic colectomy
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV morphine sulfate or Sponsor-approved equivalentDrug
Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a 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 a floor if the stay in the PACU is less than one hour.
EXPARELDrug
Also called bupivacaine liposome injectable suspension
Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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.
| Study group | Role | What they receive |
|---|---|---|
| IV Morphine Sulfate or Sponsor-approved Equivalent | Active comparator | Standard of Care (SOC) Receives: Drug: IV morphine sulfate or Sponsor-approved equivalent |
| EXPAREL | Experimental | EXPAREL (bupivacaine liposome injectable suspension) Receives: Drug: 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
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Measured: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Health Economic Benefits - Length of Stay (LOS)
Length of stay, recorded in days, 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 at time hospital discharge order is written or Day 30, whichever is sooner
Secondary outcomes (2)
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 at time hospital discharge order is written or Day 30, whichever is sooner.
Patient Satisfaction With Pain Treatment After Surgery
Responses to question pertaining to patient satisfaction with pain treatment
Measured: Wound closure at 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 posted10 Feb 2014 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionFeb 2013
Why it stopped: Slower than expected enrollment
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 Bowel ObstructionStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- Edward C Lee, MD, Principal investigator, Albany Medical CollegeKeith Candiotti, MD, Principal investigator, University of MiamiSergio Bergese, MD, Principal investigator, Ohio State UniversityEric M Haas, MD, Principal investigator, The Methodist Hospital Research InstituteJorge Marcet, MD, Principal investigator, Tampa General HospitalAnjali Kumar, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058290
- Sponsor's protocol ID
- MA402S23B6A/6B
- Acronym
- IMPROVE-Lap
- Status last verified
- Apr 2014
- First submitted
- 6 Feb 2014
- Last updated
- 14 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 14 May 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(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
- ClinicalTrials.gov ID
- NCT02058290
- Acronym / sponsor ID
- IMPROVE-Lap / MA402S23B6A/6B
- Conditions
- Bowel Obstruction
- Keywords
- laparoscopic colectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than expected enrollment
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 14 May 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 hospital 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 laparoscopic colectomy 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 |
|---|---|---|
| IV Morphine Sulfate or Sponsor-approved Equivalent | Active comparator | Drug: IV morphine sulfate or Sponsor-approved equivalentStandard of Care (SOC) |
| EXPAREL | Experimental | Drug: EXPARELEXPAREL (bupivacaine 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, at least 18 years of age.
- Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
- Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.
Key exclusion criteria (14 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 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- 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 |
|---|---|---|
| IV morphine sulfate or Sponsor-approved equivalentPatients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a 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 a floor if the stay in the PACU is less than one hour. | Drug | IV Morphine Sulfate or Sponsor-approved Equivalent |
| EXPARELAlso: bupivacaine liposome injectable suspensionPatients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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. | Drug | 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 - Total Cost of Hospitalization
Time frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Health Economic Benefits - Length of Stay (LOS)
Time frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner
Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
2 secondary outcomes
Incidence of Opioid-related Adverse Events
Time frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.
Patient Satisfaction With Pain Treatment After Surgery
Time frame: Wound closure at 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 14 May 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.
Edward C Lee, MD principal investigator
Albany Medical College
Keith Candiotti, MD principal investigator
University of Miami
Sergio Bergese, MD principal investigator
Ohio State University
6 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 IV morphine sulfate or Sponsor-approved equivalent and EXPAREL in people with Bowel Obstruction, run by Pacira Pharmaceuticals, Inc at 6 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 14 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: stopped early, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 14 May 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 NCT02058290, 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 14 May 2014.