A Phase 4 interventional study of IV morphine sulfate and EXPAREL (bupivacaine liposome injectable suspension) in Bowel Obstruction, sponsored by Pacira Pharmaceuticals, Inc. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-06.
Sponsored by Pacira Pharmaceuticals, Inc · Phase 4, Interventional, and Health services research
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.
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.
164 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.
This study's enrollment of 5 is below the median of 79 across 81 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
morphine sulfate (or Sponsor-approved equivalent)
Drug: IV morphine sulfate
EXPAREL (bupivacaine liposome injectable suspension)
Drug: EXPAREL (bupivacaine liposome injectable suspension)
Patients in this group will receive IV morphine sulfate 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.
Also known as: morphine sulfate (or Sponsor-approved equivalent)
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, a 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.
Also known as: bupivacaine free base
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
Health Economic Benefits
1. Total cost of hospitalization until the 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 Day 30
Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia.
1. 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. 2. Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Time frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner.
| Milestone | IV Morphine Sulfate | EXPAREL |
|---|---|---|
| Started | 5 | 0 |
| Completed | 5 | 0 |
| Not completed | 0 | 0 |
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
No measurements were reported for this outcome.
1. Total cost of hospitalization until the 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.
No measurements were reported for this outcome.
1. 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. 2. Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
No measurements were reported for this outcome.
Collected over 30 days post surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Morphine Sulfate | — | 2/5 (40%) | 5/5 (100%) |
| EXPAREL | — | — | — |
| Event | IV Morphine Sulfate | EXPAREL |
|---|---|---|
| Wound infectionInfections and infestations | 1/5 | — |
| Mesenteric vein thrombosisGastrointestinal disorders | 1/5 | — |
| Postoperative ileusInjury, poisoning and procedural complications | 1/5 | — |
| Event | IV Morphine Sulfate | EXPAREL |
|---|---|---|
| TachycardiaCardiac disorders | 3/5 | — |
| NauseaGastrointestinal disorders | 3/5 | — |
| Urine output decreasedInvestigations | 2/5 | — |
| LeukocytosisBlood and lymphatic system disorders | 2/5 | — |
| HypotensionVascular disorders | 2/5 | — |
| VomitingGastrointestinal disorders | 2/5 | — |
| HypocalcemiaMetabolism and nutrition disorders | 2/5 | — |
| HyponatremiaMetabolism and nutrition disorders | 2/5 | — |
| AnemiaBlood and lymphatic system disorders | 1/5 | — |
| HyperthermiaGeneral disorders | 1/5 | — |
| Age, Continuous(years) | IV Morphine Sulfate | EXPAREL | Total |
|---|---|---|---|
| Mean | 53.6 ± 13.76 | — | 53.6 ± 13.76 |
| Age, Categorical(participants) | IV Morphine Sulfate | EXPAREL | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 4 | — | 4 |
| >=65 years | 1 | — | 1 |
| Gender(participants) | IV Morphine Sulfate | EXPAREL | Total |
|---|---|---|---|
| Female | 3 | — | 3 |
| Male | 2 | — | 2 |
| Region of Enrollment(participants) | IV Morphine Sulfate | EXPAREL | Total |
|---|---|---|---|
| United States | 5 | — | 5 |
This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Liposomal Bupivacaine