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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EXPAREL
Ketorolac
laparoscopic abdominal hernia repair
an open surgery for abdominal hernia repair
Sponsored by
Michael Moncure, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain Management, Exparel, Abdominal Hernia Repair, Laparoscopic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Control Group 1

Control Group 2

Arm Description

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.

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.

Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.

Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.

Outcomes

Primary Outcome Measures

Patient satisfaction with pain management after surgery
Satisfaction measured with composite score that includes score from the Likert scale and opiod consumption/satisfaction log.

Secondary Outcome Measures

Total length of time in post-anesthesia care unit (PACU)
Length of time subject stays in the PACU
Change in postsurgical opioid consumption
Measure using date, time, amount, and route of opioids administered during the time frame

Full Information

First Posted
April 29, 2014
Last Updated
January 17, 2017
Sponsor
Michael Moncure, MD
Collaborators
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02128646
Brief Title
Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
Official Title
Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Moncure, MD
Collaborators
Pacira Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain Management, Exparel, Abdominal Hernia Repair, Laparoscopic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group 1
Arm Type
Active Comparator
Arm Description
Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.
Arm Title
Control Group 2
Arm Type
Active Comparator
Arm Description
Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.
Intervention Type
Drug
Intervention Name(s)
EXPAREL
Other Intervention Name(s)
Bupivacaine Liposome Injectable Suspension
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Type
Procedure
Intervention Name(s)
laparoscopic abdominal hernia repair
Intervention Type
Procedure
Intervention Name(s)
an open surgery for abdominal hernia repair
Primary Outcome Measure Information:
Title
Patient satisfaction with pain management after surgery
Description
Satisfaction measured with composite score that includes score from the Likert scale and opiod consumption/satisfaction log.
Time Frame
Change from Surgery to Day 14
Secondary Outcome Measure Information:
Title
Total length of time in post-anesthesia care unit (PACU)
Description
Length of time subject stays in the PACU
Time Frame
Up to 14 days
Title
Change in postsurgical opioid consumption
Description
Measure using date, time, amount, and route of opioids administered during the time frame
Time Frame
Change from Surgery to 72 hours post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Moncure, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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