EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair (702)
Primary Purpose
Hernia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EXPAREL
Sponsored by
About this trial
This is an interventional treatment trial for Hernia focused on measuring analgesia, hernia repair
Eligibility Criteria
Inclusion Criteria:
- Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
- Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
- Abdominal incision length of 3-12 cm.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
Exclusion Criteria:
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- Any female subject who is currently pregnant.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Sites / Locations
- Maimonides Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EXPAREL
Arm Description
undiluted EXPAREL 266 mg
Outcomes
Primary Outcome Measures
Overall Postsurgical Analgesic Use
The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
Secondary Outcome Measures
Postsurgical AEs and SAEs Through Day 30.
Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
Full Information
NCT ID
NCT01801124
First Posted
February 26, 2013
Last Updated
February 11, 2021
Sponsor
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01801124
Brief Title
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Acronym
702
Official Title
Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
Detailed Description
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
analgesia, hernia repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPAREL
Arm Type
Experimental
Arm Description
undiluted EXPAREL 266 mg
Intervention Type
Drug
Intervention Name(s)
EXPAREL
Other Intervention Name(s)
bupivacaine liposome injectable suspension
Intervention Description
single dose 266 mg of undiluted EXPAREL
Primary Outcome Measure Information:
Title
Overall Postsurgical Analgesic Use
Description
The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Postsurgical AEs and SAEs Through Day 30.
Description
Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
Abdominal incision length of 3-12 cm.
Subjects must be physically and mentally able to participate in the study and complete all study assessments.
Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
Exclusion Criteria:
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
Any female subject who is currently pregnant.
Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Kronenfeld, MD
Organizational Affiliation
Maimonides
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
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