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

The doses of local anesthetics can be decreased with the use of ultrasound guidance. In case of using mixture solutions the benefits and drawbacks are controversial. The plasma concentrations were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how lidocaine change the plasma concentration of bupivacaine after axillary approach to brachial plexus employed with different dilute and mixed solutions for upper limb surgery in trauma patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Arm Injury
• Intervention / Treatment: Drug: Lidocaine brachial plexus block; Drug: Bupivacaine brachial plexus block; Drug: Mixture brachial plexus block

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • University of Pécs, Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution	Drug: Lidocaine brachial plexus block; Combined Axillary-supraclavicular approach to brachial plexus with lidocaine; Other Names: Lidocain-EGIS 1% OGYI-T-3047/03
Active Comparator: Bupivacaine; Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution	Drug: Bupivacaine brachial plexus block; Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine; Other Names: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
Active Comparator: Mixture; Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution	Drug: Mixture brachial plexus block; Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%; Other Names: Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra Zeneca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal plasma concentrations	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	Onset times of local anesthetics	0-0.5 hours
Duration	Duration of actions of local anesthetics	1-24 hours

Collaborators and Investigators

• Sponsor: University of Pecs
• 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): March 17, 2017
• Primary Completion (Anticipated): December 17, 2021
• Study Completion (Anticipated): January 17, 2022

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: May 5, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No