Bupivacaine Pharmacokinetics Following… | Clinical Trial

Key information

Conditions

Transversus Abdominis Plane Block Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample for bupivicaine pharmacokinetics

Other

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).

Primary outcomes

Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition

Time frame: 0 - 360 minutes after the TAP block is performed

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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Bupivacaine Pharmacokinetics in Children Following Transversus Abdominis Plane Block

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Dec 19, 2013
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed