Bowel ObstructionPhase 4IMPROVE-OpenNCT01507246
Adult Patients Undergoing Open Colectomy MA402S23B303
A Phase 4 study testing IV morphine sulfate and EXPAREL (bupivacaine liposome injectable suspension) in people with Bowel Obstruction, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial 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. 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 and EXPAREL (bupivacaine liposome injectable suspension)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 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 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.
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.
- 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 14Show 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.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Colon and Rectal Surgery
Riverdale, Georgia, 30274
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 Open Colectomy
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.
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 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.
- Conditions
- Bowel Obstruction
- Being tested
- IV morphine sulfate, EXPAREL (bupivacaine liposome injectable suspension)
- Keywords
- open 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 sulfateDrug
Also called morphine sulfate (or Sponsor-approved equivalent)
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.
EXPAREL (bupivacaine liposome injectable suspension)Drug
Also called bupivacaine free base
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.
| Study group | Role | What they receive |
|---|---|---|
| IV morphine sulfate | Active comparator | Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. Receives: Drug: IV morphine sulfate |
| EXPAREL (bupivacaine liposome injectable suspension) | Experimental | EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc. Receives: Drug: EXPAREL (bupivacaine liposome injectable suspension) |
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 the hospital discharge order is written or through Day 30, whichever is sooner.
Measured: Wound closure to time hospital discharge order 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 is sooner.
Measured: Wound closure to time hospital discharge order written or Day 30, whichever is sooner.
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.
Measured: Up to Day 30
Secondary outcomes (1)
Incidence of Predefined Opioid-related Adverse Events
The incidence of predefined opioid-related adverse events
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionAug 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 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- Stephen Cohen, M.D., Principal investigator, Atlanta Colon and Rectal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507246
- Sponsor's protocol ID
- MA402S23B303
- Acronym
- IMPROVE-Open
- Status last verified
- May 2013
- First submitted
- 23 Oct 2011
- Last updated
- 8 May 2013
- 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 8 May 2013. 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 Open Colectomy
- ClinicalTrials.gov ID
- NCT01507246
- Acronym / sponsor ID
- IMPROVE-Open / MA402S23B303
- Conditions
- Bowel Obstruction
- Keywords
- open colectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Posted 8 May 2013
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(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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV morphine sulfate | Active comparator | Drug: IV morphine sulfateStandard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. |
| EXPAREL (bupivacaine liposome injectable suspension) | Experimental | Drug: EXPAREL (bupivacaine liposome injectable suspension)EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc. |
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 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.
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.
- 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 sulfateAlso: morphine sulfate (or Sponsor-approved equivalent)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. | Drug | IV morphine sulfate |
| EXPAREL (bupivacaine liposome injectable suspension)Also: bupivacaine free basePatients 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. | Drug | EXPAREL (bupivacaine liposome injectable suspension) |
Primary outcome
Total Opioid Burden
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- 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.
Stephen Cohen, M.D. principal investigator
Atlanta Colon and Rectal Surgery
1 site 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 and EXPAREL (bupivacaine liposome injectable suspension) in people with Bowel Obstruction, run by Pacira Pharmaceuticals, Inc at 1 site 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: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 May 2013). 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 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 NCT01507246, 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 8 May 2013.