Pain
Conditions
Brief summary
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).
Detailed description
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
Interventions
0.2 mg
DRUGEXPAREL
266 mg
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Females ≥18 years of age at screening. 2. Scheduled to undergo elective C-section (single or multiple births). 3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3. 4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion criteria
1. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids. 2. Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen. 3. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation. 4. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours. 5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration. 6. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements. 7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years. 8. Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study. 9. Previous participating in an EXPAREL study. The subject will be withdrawn from the study if she meets the following criteria: 10. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course. 11. Her baby's 5-minute Apgar score is ≤7.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Postsurgical Narcotic Consumption in Morphine Equivalents | Through 72 hours postdose | Outcome measure data refer to 7 participants who received rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postsurgical Narcotic Consumption in Morphine Equivalents | Through 24 hours | Outcome measure data refer to 6 participants who received rescue medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg | 12 |
| EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg | 0 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Standard of Care |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants |
| Age, Continuous | 32.2 years STANDARD_DEVIATION 4.71 | 32.2 years STANDARD_DEVIATION 4.71 |
| Region of Enrollment United States | 12 participants | 12 participants |
| Sex/Gender, Customized Female | 12 participants | 12 participants |
| Sex/Gender, Customized 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 | 2 / 12 | 0 / 0 |
| serious Total, serious adverse events | 0 / 12 | 0 / 0 |
Outcome results
Primary
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Time frame: Through 72 hours postdose
Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Total Postsurgical Narcotic Consumption in Morphine Equivalents | 6.1 MUEs | Standard Deviation 3.67 |
Secondary
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 6 participants who received rescue medication
Time frame: Through 24 hours
Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Total Postsurgical Narcotic Consumption in Morphine Equivalents | 4.9 MUEs | Standard Deviation 2.01 |
Secondary
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Time frame: Through 48 hours
Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Total Postsurgical Narcotic Consumption in Morphine Equivalents | 6.1 MUEs | Standard Deviation 3.67 |