Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT02755532
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block.
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: