Clinical trial NCT02755532: Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block.
Official title: A Clinical and Pharmacokinetic Study to Evaluate the Influence of Two Bupivacaine Concentrations on Peak Plasma After Ultrasound-guided Axillary Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Anesthetics, Local
Keywords: Pharmacokinetics
Bupivacaine
Axillary brachial plexus block
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem, making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little evidence exists regarding the effect of different concentrations of this drug on peak plasma levels. The present study compares two bupivacaine concentrations to establish how the concentration and exchange area affect the peak plasma level of this drug during axillary brachial plexus block. Latency and postoperative analgesia periods were also compared.

Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of 0.25% bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was injected per nerve. Peripheral blood samples were collected every 15 min during the first hour and every 30 min during the second hour to establish serum level dosage. High-performance liquid chromatography coupled with mass spectrometry was used for the analysis.


Eligibility criteria: Inclusion Criteria:

* candidates for elective surgery of the distal forearm and hand for whom brachial plexus anesthesia and analgesia were indicated.
* physical status of I or II according to American Society of Anesthesiologists (ASA) criteria
* body mass index (BMI) of less than 35 kg/m2
* Signed the free and informed consent document.

Exclusion Criteria:

* cognitive impairment
* infection at the block puncture site
* coagulopathy
* history of bupivacaine allergy

Primary outcomes:
measure: Peak Venous Plasma level of bupivacaine.
timeFrame: 2 hours
Secondary outcomes:
measure: Latency - The latency period was defined as the time interval between time zero and the time when surgical anesthesia was obtained.
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Leonardo HC Ferraro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Takeda A, Ferraro LH, Rezende AH, Sadatsune EJ, Falcao LF, Tardelli MA. Minimum effective concentration of bupivacaine for axillary brachial plexus block guided by ultrasound. Braz J Anesthesiol. 2015 May-Jun;65(3):163-9. doi: 10.1016/j.bjane.2013.11.007. Epub 2015 Feb 16.
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