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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557985
First Posted: March 20, 2012
Last Update Posted: March 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Drug: Bupivacaine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Single Dose Pharmacokinetics and Pharmacodynamics of Bupivacaine Following Transversus Abdominis Plane (TAP) Block in Neonates

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: July 2010
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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%.

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.

  Eligibility

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557985


Locations
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Santhanam Suresh, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:

Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01557985     History of Changes
Other Study ID Numbers: CMH IRB 2010-14308
First Submitted: March 13, 2012
First Posted: March 20, 2012
Last Update Posted: March 21, 2013
Last Verified: March 2013

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
children
regional anesthesia
postoperative pain management
local anesthetic solution
toxicity

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents