Postoperative Pain
Conditions
Keywords
hysterectomy, analgesia
Brief summary
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
Detailed description
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
Interventions
DRUGEXPAREL
Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Females, 18-75 years of age inclusive. * American Society of Anesthesiologist (ASA) physical status 1-3. * Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s). * Physically and mentally able to participate in the study and complete all study assessments. * Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.
Exclusion criteria
* Demonstrated 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. * 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. * 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 |
|---|---|
| Duration of Analgesia | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | 10 days post surgery plus or minus 3 days |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EXPAREL Group 1 EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. | 1 |
| EXPAREL Group 2 EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | EXPAREL Group 1 | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 0 | 67 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Duration of Analgesia
Time frame: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
Secondary
Incidence of Adverse Events
Time frame: 10 days post surgery plus or minus 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EXPAREL Group 1 | Incidence of Adverse Events | 0 number of events |