- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527836
Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix] (PCLBAxMix)
Comparison of Plasma Concentrations of Lidocaine and Bupivacaine After Ultrasound-guided Axillary Approach to Brachial Plexus Block Used With Different Dilute Mixture Solutions for Upper Limb Trauma Surgery
Study Overview
Status
Conditions
Detailed Description
Total of 30 American Society of Anesthesiologist (ASA) I-III adult patients scheduled to elective or emergency trauma surgery of hand and forearm under ultrasound-guided (UG) brachial plexus block (BPB) are planned to be assigned into this randomized-prospective observational study after approval by the University Research Ethics Board, Pécs University Medical School, Hungary. All of the patients will receive detailed information about the planned BPB techniques and surgeries, then written informed consents will be obtained.
Study participants are planned to be assigned randomly by the research coordinator into 3 groups (Lidocaine, Bupivacaine and mixture solution) according to the concentration of lidocaine and bupivacaine in the mixture solution.
Standardized UG Axillary-supraclavicular (AX-SC) approach to the BP is planned to be performed under sterile conditions by the same anesthesiologist. The standardized dose is 0.4 ml/kg with the targeted maximized the single-shot volume of 30 ml.
Blood samples will be taken at 0-time point (straight after the administration of BP injection) and 30, 60, 240 and 480 minutes after. Plasma concentrations are determined, the results are collected and analyzed.
Under standard monitorization, vital parameters, data are collected on the onset time and duration of actions of local anesthetics (LAs).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baranya
-
Pécs, Baranya, Hungary, 7632
- University of Pécs, Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB
Exclusion Criteria:
- continuous peripheral nerve catheter technique or bilateral block was planned, or the patient refused to participate. Exclusion criteria included psycho-mental conditions interfering with consent or assessment; pre-existing chronic pain condition or daily analgesic or sedative consumption; sedative or analgesic premedication; pre-existing neurological disorders affecting the brachial plexus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lidocaine
Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution
|
Combined Axillary-supraclavicular approach to brachial plexus with lidocaine
Other Names:
|
Active Comparator: Bupivacaine
Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
|
Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine
Other Names:
|
Active Comparator: Mixture
Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution
|
Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal plasma concentrations
Time Frame: 0-8 hours
|
Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection
|
0-8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset times
Time Frame: 0-0.5 hours
|
Onset times of local anesthetics
|
0-0.5 hours
|
Duration
Time Frame: 1-24 hours
|
Duration of actions of local anesthetics
|
1-24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert G Almasi, PhD. habil, University of Pecs, Medical School, Pain Medicine Dept.of Anesth Int Care
- Principal Investigator: Barbara Rezman, MD, University of Pecs, Medical School, Dept.of Anesth Int Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Arm Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
Other Study ID Numbers
- 6634 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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