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

Sponsor

University of Pecs (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03527836

Collaborator

(none)

Enrollment

Location

Arms

58.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arm Injury	Drug: Lidocaine brachial plexus block Drug: Bupivacaine brachial plexus block Drug: Mixture brachial plexus block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture groupStudy participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group

Masking:

Triple (Participant, Investigator, Outcomes 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.

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 17, 2017

Anticipated Primary Completion Date :

Dec 17, 2021

Anticipated Study Completion Date :

Jan 17, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Onset times [0-0.5 hours]
Onset times of local anesthetics
Duration [1-24 hours]
Duration of actions of local anesthetics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pécs, Medical School	Pécs	Baranya	Hungary	7632

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pecs

ClinicalTrials.gov Identifier:

NCT03527836

Other Study ID Numbers:

6634

First Posted:

May 17, 2018

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arm Injuries

Lidocaine

Bupivacaine

Study Results

No Results Posted as of Jul 22, 2021