Exparel PK and Breast Milk Excretion
Completed
Conditions studied: Milk Expression, Breast
In brief
Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery
Key facts
- Study ID
- NCT03526419
- Run by
- University of Minnesota
- People needed
- 30
- Starts
- 2019-02-01
- Expected to finish
- 2019-09-01
- Last updated by the study team
- 2019-09-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women >18 year old, scheduled for elective Cesarean delivery and who desire to have a TAP block performed after delivery.
- American Society of Anesthesiologists physical status I, II, and III
You may not qualify if…
- Patient refusal or inability to cooperate.
- Allergy, hypersensitivity, intolerance, or contraindication to liposomal bupivacaine.
- 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 [ULN], or serum alanine aminotransferase [ALT] level >3 times the ULN).
- Participants at an increased risk for bleeding or with any coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5) (all contraindications to TAP block).
- 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.
- Patient membership in a vulnerable population such as a prisoner, mentally unable to provide direct consent etc.
- Participant has contraindication to breastfeeding or not planning to breastfeed the first 2-3 days after delivery.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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