Bupivacaine Pharmacokinetics Following TAP Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transversus Abdominis Plane Block

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood sample for bupivicaine pharmacokinetics

Children undergoing TAP block will have blood sampled for bupivacaine pharmacokinetics

Blood sample for bupivicaine pharmacokinetics

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No