Status:
WITHDRAWN
Post C-Section Pain Control Using EXPAREL
Lead Sponsor:
University of Minnesota
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in patients undergoing scheduled cesarean section by giving it either as infiltration in Transversus Abdominis P...
Eligibility Criteria
Inclusion
- Females 18 years of age and older at screening.
- Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- ASA (American Society of Anesthesiologists) physical status 1, 2, or 3 are able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
Exclusion
- Age \<18
- BMI \> or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
- Planned general anesthetic
- Cesarean delivery via vertical skin incision
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
- Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- Severely impaired renal or hepatic function (eg, serum creatinine level \>2 mg/dL \[176.8 µmol/L\], blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\], serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal , or serum alanine aminotransferase \[ALT\] level \>3 times the upper limit of normal.)
- Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5).
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
- Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
- Previous participation in an EXPAREL study.
- Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
- 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.
- 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.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03377595
Start Date
July 2 2019
End Date
September 1 2019
Last Update
May 18 2021
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455