Exparel PK and Breast Milk Excretion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-09-01

Brief Summary

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

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Detailed Description

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Conditions

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Milk Expression, Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bupivacaine liposome

blood and milk samples will be obtained from those subjects after TAP block

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes