Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01507233
Other study ID # MA402S23B302
Secondary ID
Status Terminated
Phase Phase 4
First received October 24, 2011
Last updated January 19, 2014
Start date May 2012
Est. completion date July 2012

Study information

Verified date January 2014
Source Pacira Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female, 18 years of age or 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 a 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 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
IV morphine sulfate
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.
EXPAREL (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 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.

Locations

Country Name City State
United States University of Miami, Dept of Anesthesiology Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Pacira Pharmaceuticals, Inc Registrat-Mapi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Wound closure to time hospital discharge order written or Day 30, whichever is sooner No
Primary Health Economic Benefits Total cost of hospitalization until the time hospital discharge order is written or through 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.
Wound closure to Day 30 No
Secondary Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia. 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.
Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Wound closure to time hospital discharge order written or Day 30, whichever is sooner. No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05442164 - Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT04613063 - Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
Recruiting NCT06089551 - Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery Phase 4
Completed NCT03202576 - Nasogastric Tube Securement Comparison Study N/A
Completed NCT01040364 - Internal Hernias After Laparoscopic Gastric Bypass N/A
Not yet recruiting NCT04848415 - Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction
Terminated NCT01507220 - A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 Phase 4
Completed NCT04898842 - Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet N/A
Not yet recruiting NCT05253222 - Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET N/A
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A
Recruiting NCT04539028 - Emergency General Surgery for Non-trauma
Terminated NCT01911793 - Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery N/A
Recruiting NCT03150992 - EDMONd - Elemental Diet in Bowel Obstruction N/A
Terminated NCT02116881 - Incisional Hernia and Adhesion-Related Bowel Obstruction N/A
Recruiting NCT00164879 - Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers Phase 3
Completed NCT03350022 - Sham Feeding Post-operative Infants N/A
Not yet recruiting NCT03593252 - Bowel Preparation in Elective Pediatric Colorectal Surgery N/A
Completed NCT05753709 - Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study N/A
Enrolling by invitation NCT05085353 - Fetal Outcomes Among Pregnant Emergency General Surgery Patients