Hernia
Conditions
Keywords
analgesia, hernia repair
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.
Interventions
DRUGEXPAREL
single dose 266 mg of undiluted EXPAREL
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA.
Pre-assignment details
Subjects were not excluded.
Participants by arm
| Arm | Count |
|---|---|
| EXPAREL undiluted EXPAREL 266 mg | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | EXPAREL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 45.7 years STANDARD_DEVIATION 12.72 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
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)
Time frame: 10 days
Population: The analysis population comprised all enrolled subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EXPAREL | Overall Postsurgical Analgesic Use | 9.7 mg (morphine equivalents) | Standard Deviation 17.41 |
Secondary
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.
Time frame: 30 days
Population: The analysis population comprised all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EXPAREL | Postsurgical AEs and SAEs Through Day 30. | 0 AEs |