Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
NCT ID: NCT02128646
Last Updated: 2025-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
19 participants
INTERVENTIONAL
2014-04-30
2017-01-31
Brief Summary
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Detailed Description
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Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group 1
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair.
EXPAREL
Ketorolac
an open surgery for abdominal hernia repair
Treatment Group 2
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair.
EXPAREL
Ketorolac
laparoscopic abdominal hernia repair
Control Group 1
Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.
an open surgery for abdominal hernia repair
Control Group 2
Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.
laparoscopic abdominal hernia repair
Interventions
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EXPAREL
Ketorolac
laparoscopic abdominal hernia repair
an open surgery for abdominal hernia repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.
Exclusion Criteria
* Patients who abuse alcohol or other drug substance.
* Patients who are on chronic opioid therapy (taken an opioid 5 of the last 7 days).
* Patients with severe hepatic impairment.
* Patients currently pregnant.
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Michael Moncure, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00000101
Identifier Type: -
Identifier Source: org_study_id
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