NCT02015182

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

August 21, 2013

Last Update Submit

April 14, 2016

Conditions

Transversus Abdominis Plane Block

Keywords

BupivacaineSensorcainePopulation pharmacokineticsChildrenPediatricsTransversus abdominis plane (TAP) blockRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Blood sample for bupivicaine pharmacokinetics

Children undergoing TAP block will have blood sampled for bupivacaine pharmacokinetics

Other: Blood sample for bupivicaine pharmacokinetics

Interventions

Blood sample for bupivicaine pharmacokineticsOTHER

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).

Blood sample for bupivicaine pharmacokinetics

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing TAP block for postoperative pain control

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (serum)

MeSH Terms

Conditions

Bites and Stings

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jason Hayes

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

August 21, 2013

First Posted

December 19, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

CA(1)