Exparel PK and Breast Milk Excretion | NCT03526419

Studies
Exparel PK and Breast Milk Excretion

NCT03526419

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Sep 25, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Milk Expression, Breast

Interventions

Bupivacaine liposome

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

May 3, 2018

First Submission Date that Met QC Criteria

May 15, 2018

First Posted Date

May 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2019

Last Update Posted Date

Sep 25, 2019Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine liposome	Drug	blood and milk samples will be obtained from those subjects after TAP block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant patients undergoing scheduled C-section delivery

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32541292	Derived	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.

ID	Term
D001942	Breast Feeding
D005247	Feeding Behavior
D001519	Behavior