Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block.

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

October 31, 2015

Conditions
PharmacokineticsAnesthetics, Local
Interventions
DRUG

Bupivacaine 0,25%

Venous blood samples were collected prior to blocking , every 15 min during the first hour after completion of the blocking and every 30 min during the second hour after completion using an exclusive cannula. Then, 5 ml was drawn off and was stored in two EDTA tubes (BD, Franklin Lakes, NJ, USA). The EDTA tubes were centrifuged at 3,500xg for 10 min to obtain the blood plasma. This plasma was then stored in cryogenic tubes in a freezer at -80 °C until the time of the analysis. A high-performance liquid chromatography apparatus (Shimadzu, Kyoto, Japan) coupled to a Bruker mass spectrometer (MS), model Amazon (USA), with electrospray source ionization and a sequential mass spectrometry system (MS/MS) were used for the analysis. After obtaining the precursor ion, a fragment was obtained via a collision-induced dissociation process. The following molecular ions were selected: 289.0 m/z==\>140.1 m/z. The methodology was validated according to the international FDA recommendations.

DRUG

Bupivacaine 0,5%

Venous blood samples were collected prior to blocking , every 15 min during the first hour after completion of the blocking and every 30 min during the second hour after completion using an exclusive cannula. Then, 5 ml was drawn off and was stored in two EDTA tubes (BD, Franklin Lakes, NJ, USA). The EDTA tubes were centrifuged at 3,500xg for 10 min to obtain the blood plasma. This plasma was then stored in cryogenic tubes in a freezer at -80 °C until the time of the analysis. A high-performance liquid chromatography apparatus (Shimadzu, Kyoto, Japan) coupled to a Bruker mass spectrometer (MS), model Amazon (USA), with electrospray source ionization and a sequential mass spectrometry system (MS/MS) were used for the analysis. After obtaining the precursor ion, a fragment was obtained via a collision-induced dissociation process. The following molecular ions were selected: 289.0 m/z==\>140.1 m/z. The methodology was validated according to the international FDA recommendations.

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

Federal University of São Paulo

OTHER

NCT02755532 - Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block. | Biotech Hunter | Biotech Hunter