Single Dose Pharmacokinetics and Pharmacodynamics of Bupivacaine Following Transversus Abdominis Plane (TAP) Block in Neonates

June 9, 2025 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
This study is being done to try to learn more about how a child's body breaks down bupivacaine, a local anesthetic medication that is being used for pain control. This study will provide information about how much medication gets into the bloodstream and how long it remains in the blood. Newborns and young infants often process drugs in their body in a different way than older children. This study will help the investigators determine how bupivacaine is broken down in the body of infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A transverse abdominal plane (TAP_ block will be performed by one of the investigators who is adept in using ultrasound guidance after induction of general anesthesia. The dose of bupivacaine administered will be based on the weight of the patient. This dose is consistent with routine levels of local anesthetic used for peripheral nerve blocks and is lower than toxic levels so there will be no additional change in renal or liver function. Whole blood samples will be collected on a piece of filter paper from either an arterial, central, peripheral line or heel stick. The extracts from dried blood samples (DBS; calculated volume 20 µL) collected on filter paper will be analyzed using an LC-MS/MS system in combination with online extraction (LC/LC-MS/MS). Blood samples will be obtained at 0, 5, 15, 30, 60, 120 minutes, 4, 24, 48 hours. If obtained from a heel stick, these samples will be obtained at time of glucose sampling or a clinical indication. Subjects will be considered evaluable if they have 5 samples. All sampling for the study will be based on concurrent sampling so there will be no additional blood draws.

Pain will be assessed by the bedside nurse or study research assistant using the Neonatal Infant Pain Scale (NIPS). As part of the standard of care in this institution, nurses will have the opportunity to administer additional pain medications including but not limited to intravenous fentanyl or morphine. This will be done as per standing orders if the neonate meets criteria for additional analgesia, in other words, if there is an increase in pain as indicated by the NIPS pain scores. NIPS score will be recorded prior to each blood draw and every 8 hours while the subject is enrolled in the study. The NIPS will be the primary clinical outcome measure for this study. Blood pressure and heart rate will also be recorded as a physiologic correlate for drug level at these times.

Study Type

Observational

Enrollment (Actual)

10

Phase

  • Phase 2

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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's Hospital of Chicago

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

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates younger than 28 days undergoing any abdominal surgery.

Description

Inclusion Criteria:

  • Neonates under 28 days of age undergoing any abdominal surgery including laparotomy, colostomy placement. In addition neonates who have procedures performed using laparoscopic as well as open techniques will be included
  • Written informed consent from parent or guardian

Exclusion Criteria:

  • Neonates with significant cardiovascular disease (any child with any congenital heart disease will be excluded from the study)
  • Neonates with significant liver disease (any neonate with ALT/AST elevated 30% above normal values as determined by the lab at Lurie Children's at the time of testing)
  • Neonates under 1.65 kg

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transversus abdominis plane (TAP) Block
All participants in the study will receive a Transverses abdominis plane (TAP) Block in conjunction with their surgery.
Drug: Bupivacaine
The volume of Bupivacaine per block will be 0.5 mL at 0.125%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of Bupivacaine
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Cmax of bupivacaine in neonates undergoing the TAP block over a period of 48 hours
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics of Bupivacaine
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Validated observational pain scale, Neonatal Infant Pain Scale (NIPS), as a clinical outcome correlate for bupivacaine levels
participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Collaborators and Investigators

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Santhanam Suresh, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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

July 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimated)

March 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMH IRB 2010-14308

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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