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

NCT03527836 | Unknown

• 1 other identifier: 6634
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Injury

Outcome Measures

Primary Outcomes (1)

• Maximal plasma concentrations

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

  0-8 hours

Secondary Outcomes (2)

• Onset times

  0-0.5 hours

• Duration

  1-24 hours

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine brachial plexus block

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine brachial plexus block

Mixture

ACTIVE COMPARATOR

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

Drug: Mixture brachial plexus block

Interventions

Lidocaine brachial plexus block DRUG

Combined Axillary-supraclavicular approach to brachial plexus with lidocaine

Also known as: Lidocain-EGIS 1% OGYI-T-3047/03

Lidocaine

Bupivacaine brachial plexus block DRUG

Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine

Also known as: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14

Bupivacaine

Mixture brachial plexus block DRUG

Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%

Also known as: Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra Zeneca

Mixture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs, Medical School

Pécs, Baranya, 7632, Hungary

Location

MeSH Terms

Conditions

Arm Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Robert G Almasi, PhD. habil

  University of Pecs, Medical School, Pain Medicine Dept.of Anesth Int Care

  STUDY CHAIR

• Barbara Rezman, MD

  University of Pecs, Medical School, Dept.of Anesth Int Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: May 17, 2018
• Study Start: March 17, 2017
• Primary Completion: December 17, 2021
• Study Completion: January 17, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)