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OpenTrials
Completed

NCT Number: NCT03526419

Exparel PK and Breast Milk Excretion

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Bupivacaine liposome

Drug

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

Primary outcomes

  1. milk plasma ratio

    Time frame: 72 hours

    AUC for the milk/plasma drug ratio

Secondary outcomes

  1. AUC of plasma

    Time frame: 72 hours

    AUC for drug concentration in plasma

  2. AUC of milk

    Time frame: 72 hours

    AUC for drug concentration in milk

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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