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

NCT01557985 | Completed DMC

• 1 other identifier: CMH IRB 2010-14308
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

children; regional anesthesia; postoperative pain management; local anesthetic solution; toxicity

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of Bupivacaine

  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 Outcomes (1)

• Pharmacodynamics of Bupivacaine

  participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Study Arms (1)

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

Interventions

Bupivacaine DRUG

The volume of Bupivacaine per block will be 0.5 mL at 0.125%.

Transversus abdominis plane (TAP) Block

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates younger than 28 days undergoing any abdominal surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Abdel-Rahman SM, Jacobs RF, Massarella J, Kauffman RE, Bradley JS, Kimko HC, Kearns GL, Shalayda K, Curtin C, Maldonado SD, Blumer JL. Single-dose pharmacokinetics of intravenous itraconazole and hydroxypropyl-beta-cyclodextrin in infants, children, and adolescents. Antimicrob Agents Chemother. 2007 Aug;51(8):2668-73. doi: 10.1128/AAC.00297-07. Epub 2007 May 21.

  PMID: 17517842 BACKGROUND

• Bielsky A, Efrat R, Suresh S. Postoperative analgesia in neonates after major abdominal surgery: 'TAP' our way to success! Paediatr Anaesth. 2009 May;19(5):541-2. doi: 10.1111/j.1460-9592.2009.02988.x. No abstract available.

  PMID: 19453587 BACKGROUND

• Zhang YL, Bendrick-Peart J, Strom T, Haschke M, Christians U. Development and validation of a high-throughput assay for quantification of the proliferation inhibitor ABT-578 using LC/LC-MS/MS in blood and tissue samples. Ther Drug Monit. 2005 Dec;27(6):770-8. doi: 10.1097/01.ftd.0000185766.52126.bd.

  PMID: 16306853 BACKGROUND

• Frassetto L, Baluom M, Jacobsen W, Christians U, Roland ME, Stock PG, Carlson L, Benet LZ. Cyclosporine pharmacokinetics and dosing modifications in human immunodeficiency virus-infected liver and kidney transplant recipients. Transplantation. 2005 Jul 15;80(1):13-7. doi: 10.1097/01.tp.0000165111.09687.4e.

  PMID: 16003227 BACKGROUND

• Christians U, Jacobsen W, Serkova N, Benet LZ, Vidal C, Sewing KF, Manns MP, Kirchner GI. Automated, fast and sensitive quantification of drugs in blood by liquid chromatography-mass spectrometry with on-line extraction: immunosuppressants. J Chromatogr B Biomed Sci Appl. 2000 Oct 1;748(1):41-53. doi: 10.1016/s0378-4347(00)00380-7.

  PMID: 11092585 BACKGROUND

• Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

  PMID: 8413140 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Santhanam Suresh, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 20, 2012
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)