Milk Expression, Breast
Conditions
Keywords
Liposomal bupivacaine, TAP block, cesarean section
Brief summary
Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery
Interventions
blood and milk samples will be obtained from those subjects after TAP block
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women \>18 year old, scheduled for elective Cesarean delivery and who desire to have a TAP block performed after delivery. 2. American Society of Anesthesiologists physical status I, II, and III
Exclusion criteria
1. Patient refusal or inability to cooperate. 2. Allergy, hypersensitivity, intolerance, or contraindication to liposomal bupivacaine. 3. 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). 4. 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). 5. 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. 6. Patient membership in a vulnerable population such as a prisoner, mentally unable to provide direct consent etc. 7. Participant has contraindication to breastfeeding or not planning to breastfeed the first 2-3 days after delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| milk plasma ratio | 72 hours | AUC for the milk/plasma drug ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of plasma | 72 hours | AUC for drug concentration in plasma |
| AUC of milk | 72 hours | AUC for drug concentration in milk |
Countries
United States
Outcome results
None listed