Exparel PK and Breast Milk Excretion

Milk Expression, Breast Clinical Trial

Official title:

Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine After TAP Block in Patients Undergoing Cesarean Section Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526419
• Other study ID #: STUDY00003258
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Milk Expression, Breast

Intervention

Drug:
• Bupivacaine liposome
blood and milk samples will be obtained from those subjects after TAP block

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	milk plasma ratio	AUC for the milk/plasma drug ratio	72 hours
Secondary	AUC of plasma	AUC for drug concentration in plasma	72 hours
Secondary	AUC of milk	AUC for drug concentration in milk	72 hours