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Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix] (PCLBAxMix)

Primary Purpose

Arm Injury

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Lidocaine brachial plexus block
Bupivacaine brachial plexus block
Mixture brachial plexus block
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arm Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pécs, Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lidocaine

Bupivacaine

Mixture

Arm Description

Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution

Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution

Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution

Outcomes

Primary Outcome Measures

Maximal plasma concentrations
Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection

Secondary Outcome Measures

Onset times
Onset times of local anesthetics
Duration
Duration of actions of local anesthetics

Full Information

First Posted
February 15, 2018
Last Updated
July 21, 2021
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT03527836
Brief Title
Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]
Acronym
PCLBAxMix
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
December 17, 2021 (Anticipated)
Study Completion Date
January 17, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Injury

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, the operating team, nurses, and observers involved in the assessment of the follow-up data collection were unaware of group allocation. The labor analyst is unaware of group allocation. The list of cases will be provided in spreadsheet program by an observer-blinded assistant and was statistically evaluated by an independent analyst.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
Arm Title
Mixture
Arm Type
Active Comparator
Arm Description
Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution
Intervention Type
Drug
Intervention Name(s)
Lidocaine brachial plexus block
Other Intervention Name(s)
Lidocain-EGIS 1% OGYI-T-3047/03
Intervention Description
Combined Axillary-supraclavicular approach to brachial plexus with lidocaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine brachial plexus block
Other Intervention Name(s)
Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
Intervention Description
Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine
Intervention Type
Drug
Intervention Name(s)
Mixture brachial plexus block
Other Intervention Name(s)
Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra Zeneca
Intervention Description
Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%
Primary Outcome Measure Information:
Title
Maximal plasma concentrations
Description
Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection
Time Frame
0-8 hours
Secondary Outcome Measure Information:
Title
Onset times
Description
Onset times of local anesthetics
Time Frame
0-0.5 hours
Title
Duration
Description
Duration of actions of local anesthetics
Time Frame
1-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Almasi, PhD. habil
Organizational Affiliation
University of Pecs, Medical School, Pain Medicine Dept.of Anesth Int Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbara Rezman, MD
Organizational Affiliation
University of Pecs, Medical School, Dept.of Anesth Int Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pécs, Medical School
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]

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