702: EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Study Details
Study Description
Brief Summary
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EXPAREL undiluted EXPAREL 266 mg |
Drug: EXPAREL
single dose 266 mg of undiluted EXPAREL
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Postsurgical Analgesic Use [10 days]
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. [30 days]
Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
Sponsors and Collaborators
- Pacira Pharmaceuticals, Inc
Investigators
- Principal Investigator: Mark Kronenfeld, MD, Maimonides
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA402S23B702
Study Results
Participant Flow
Recruitment Details | Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA. |
---|---|
Pre-assignment Detail | Subjects were not excluded. |
Arm/Group Title | EXPAREL |
---|---|
Arm/Group Description | All subjects received a total of 266mg EXPAREL (bupicavaine liposome injectable suspension) diluted with preservative-free 0.9% normal saline to a volume of 30mL. Study drug was to be administered with ultrasound guidance by injection through a needle or catheter into the tissue plane between the transversus abdominis and internal oblique muscles of the abdominal wall. |
Period Title: Overall Study | |
STARTED | 13 |
COMPLETED | 13 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | EXPAREL |
---|---|
Arm/Group Description | undiluted EXPAREL 266 mg |
Overall Participants | 13 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
13
100%
|
>=65 years |
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
45.7
(12.72)
|
Sex: Female, Male (Count of Participants) | |
Female |
3
23.1%
|
Male |
10
76.9%
|
Region of Enrollment (participants) [Number] | |
United States |
13
100%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population comprised all enrolled subjects. |
Arm/Group Title | EXPAREL |
---|---|
Arm/Group Description | Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs. |
Measure Participants | 13 |
Mean (Standard Deviation) [mg (morphine equivalents)] |
9.7
(17.41)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population comprised all enrolled subjects. |
Arm/Group Title | EXPAREL |
---|---|
Arm/Group Description | Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs. |
Measure Participants | 13 |
Number [AEs] |
0
|
Adverse Events
Time Frame | Through Day 30 | |
---|---|---|
Adverse Event Reporting Description | Adverse events were collected by the investigator from the time of signing the informed consent form through 30 days post surgery. | |
Arm/Group Title | EXPAREL | |
Arm/Group Description | Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs. | |
All Cause Mortality |
||
EXPAREL | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
EXPAREL | ||
Affected / at Risk (%) | # Events | |
Total | 0/13 (0%) | |
Other (Not Including Serious) Adverse Events |
||
EXPAREL | ||
Affected / at Risk (%) | # Events | |
Total | 0/13 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Mark Kronefeld, MD |
---|---|
Organization | Maimonides Medical Center |
Phone | (718) 283-8816 |
- MA402S23B702