Exparel PK and Breast Milk Excretion

September 23, 2019 updated by: University of Minnesota

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant patients undergoing scheduled C-section delivery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
milk plasma ratio
Time Frame: 72 hours
AUC for the milk/plasma drug ratio
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of plasma
Time Frame: 72 hours
AUC for drug concentration in plasma
72 hours
AUC of milk
Time Frame: 72 hours
AUC for drug concentration in milk
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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