Exparel PK and Breast Milk Excretion

NCT03526419 | Completed DMC FDA Drug

• 1 other identifier: STUDY00003258
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Milk Expression, Breast

Keywords

Liposomal bupivacaine; TAP block; cesarean section

Outcome Measures

Primary Outcomes (1)

• milk plasma ratio

  AUC for the milk/plasma drug ratio

  72 hours

Secondary Outcomes (2)

• AUC of plasma

  72 hours

• AUC of milk

  72 hours

Interventions

Bupivacaine liposome DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant patients undergoing scheduled C-section delivery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 32541292 DERIVED

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: February 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)