Bupivacaine Pharmacokinetics Following TAP Block

Transversus Abdominis Plane Block Clinical Trial

Official title:

Bupivacaine Pharmacokinetics in Children Following Transversus Abdominis Plane Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015182
• Other study ID #: 1000023222
• Status: Completed
• Phase: N/A
• First received: August 21, 2013
• Last updated: April 14, 2016
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The aims of this study are to determine population PK parameters of bupivacaine in children following TAP block using a population-based PK approach, and to evaluate the influence of patient covariates on drug disposition.

Description:

The number of published pediatric studies on the use of transversus abdominis plane (TAP) block has increased in recent years. The transversus abdominis plane (TAP) block has been used for postoperative analgesia for surgery to the abdominal wall and involves the injection of local anesthetic solution into a plane between internal oblique (IO) and transversus abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in instances of non-midline abdominal incision and is particularly useful in cases where epidural blockade is either contraindicated or technically or logistically not feasible. Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after TAP block in children. The aims of this study are to determine population pharmacokinetic (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• Patients receiving a TAP block as part of routine anesthetic management

• Patients older than 3 months and less than 18 years of age

• Patients weighing = 6 kg

• Patients with American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria:

• Patients with known severe preexisting liver disease

• Patients with known severe (i.e. requiring dialysis) preexisting renal disease

• Patients who will be discharged the day of surgery

• Refusal to consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Transversus Abdominis Plane Block

Intervention

Other:
• Blood sample for bupivicaine pharmacokinetics
Bupivacaine levels will be measured with an assay developed on the 4000 QTrap Tandem Mass Spectrometer (Applied Biosystems/ MDS Sciex). Data will be collected and analyzed using the Agilent ChemStation software (Rev A.10.02). The analytical column is an Agilent Zorbax Eclipse XDB-C8 (4.6 x 150mm, 5µm).Quantification of bupivacaine is based on analyzing a six point calibration curve (0 to 4.0 mg/L). An internal standard (Prilocaine 221.2/86.1) is included with each calibrator, quality control or patient sample. Instrumentation and Chromatographic conditions: The HPLC system consists of a Specta-System P1000 Isocratic Pump and an AS3000 Autosampler (Thermo Electron Corporation, Waltham MA).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition	Blood will be drawn from an indwelling intravenous catheter. Each patient will have a total of 6 samples collected during each of the following time blocks: 0 - 10 minutes, 11 - 20 minutes, 21 - 30 minutes, 31 - 60 minutes, 61 - 180 minutes and 181 - 360 minutes after the TAP block is performed. Age, weight, sex, concomitant drugs (intravenous and inhalation anesthetics, muscle relaxants, and opioids), and kidney function data will be investigated as co-variables for each of the primary parameters. We will obtain estimates of total clearance (CL), volume of distribution, elimination half life (t1/2), estimates of clearance, and absorption rate constant.	0 - 360 minutes after the TAP block is performed	No