Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128646
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Michael Moncure, MD, University of Kansas Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.

Condition or disease Intervention/treatment Phase
Pain Drug: EXPAREL Drug: Ketorolac Procedure: laparoscopic abdominal hernia repair Procedure: an open surgery for abdominal hernia repair Phase 4

Detailed Description:

When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs & Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation.

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
Study Start Date : April 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Drug: EXPAREL
Other Name: Bupivacaine Liposome Injectable Suspension

Drug: Ketorolac
Other Name: Toradol

Procedure: an open surgery for abdominal hernia repair
Experimental: 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.
 Drug: EXPAREL
Other Name: Bupivacaine Liposome Injectable Suspension

Drug: Ketorolac
Other Name: Toradol

Procedure: laparoscopic abdominal hernia repair
Active Comparator: 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.
 Procedure: an open surgery for abdominal hernia repair
Active Comparator: Control Group 2
Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.
 Procedure: laparoscopic abdominal hernia repair


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patient satisfaction with pain management after surgery [ Time Frame: Change from Surgery to Day 14 ]
    Satisfaction measured with composite score that includes score from the Likert scale and opiod consumption/satisfaction log.


Secondary Outcome Measures :
  1. Total length of time in post-anesthesia care unit (PACU) [ Time Frame: Up to 14 days ]
    Length of time subject stays in the PACU

  2. Change in postsurgical opioid consumption [ Time Frame: Change from Surgery to 72 hours post-surgery ]
    Measure using date, time, amount, and route of opioids administered during the time frame


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo an open or laparoscopic abdominal hernia repair.
  • Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

  • Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids or ketorolac.
  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128646


Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Michael Moncure, MD
Pacira Pharmaceuticals, Inc
Investigators
Layout table for investigator information
Principal Investigator: Michael Moncure, MD University of Kansas Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Michael Moncure, MD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02128646    
Other Study ID Numbers: STUDY00000101
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Keywords provided by Michael Moncure, MD, University of Kansas Medical Center:
Pain Management
Exparel
Abdominal Hernia Repair
Laparoscopic Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Hernia
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Ketorolac
Bupivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action