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).
Brief Title
Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean 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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02353754
Org Class
Industry
Org Full Name
Pacira Pharmaceuticals, Inc
Org Study Id
402-C-402
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
Primary Outcomes
Outcome Description
Outcome measure data refer to 7 participants who received rescue medication
Outcome Measure
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome Time Frame
Through 72 hours postdose
Secondary Outcomes
Outcome Description
Outcome measure data refer to 6 participants who received rescue medication
Outcome Time Frame
Through 24 hours
Outcome Measure
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome Description
Outcome measure data refer to 7 participants who received rescue medication
Outcome Time Frame
Through 48 hours
Outcome Measure
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Boleslav Kosharskyy
Investigator Email
bkoshars@montefiore.org
Investigator Phone