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CompletedNCT03526419Updated Sep 25, 2019

Exparel PK and Breast Milk Excretion

An observational study in Milk Expression, Breast, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Milk Expression, Breast

Keywords

  • Liposomal bupivacaine
  • TAP block
  • cesarean section
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant patients undergoing scheduled C-section delivery

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DrugBupivacaine liposome

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

06

What researchers measure

Primary outcomes

  1. milk plasma ratio

    AUC for the milk/plasma drug ratio

    Time frame: 72 hours

Secondary outcomes

  1. AUC of plasma

    AUC for drug concentration in plasma

    Time frame: 72 hours

  2. AUC of milk

    AUC for drug concentration in milk

    Time frame: 72 hours

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

Publications

  • Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886. PubMed 32541292 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03526419
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
May 16, 2018
Start date
Feb 1, 2019
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Sep 25, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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