Arm InjuryPCLBAxMixNCT03527836
Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]
A study testing Lidocaine brachial plexus block, Bupivacaine brachial plexus block and Mixture brachial plexus block in people with Arm Injury, run by University of Pecs at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arm Injury
- What is being tested?
- Lidocaine brachial plexus block, Bupivacaine brachial plexus block and Mixture brachial plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 17 Mar 2017to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Arm Injury
- Being tested
- Lidocaine brachial plexus block, Bupivacaine brachial plexus block, Mixture brachial plexus block
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine brachial plexus blockDrug
Also called Lidocain-EGIS 1% OGYI-T-3047/03
Combined Axillary-supraclavicular approach to brachial plexus with lidocaine
Bupivacaine brachial plexus blockDrug
Also called Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine
Mixture brachial plexus blockDrug
Also called Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra Zeneca
Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution Receives: Drug: Lidocaine brachial plexus block |
| Bupivacaine | Active comparator | Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution Receives: 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 Receives: Drug: Mixture brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal plasma concentrations
Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection
Measured: 0-8 hours
Secondary outcomes (2)
Onset times
Onset times of local anesthetics
Measured: 0-0.5 hours
Duration
Duration of actions of local anesthetics
Measured: 1-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start17 Mar 2017
- Primary completion17 Dec 2021 (estimated)
- Study completion17 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert G Almasi, PhD. habil, Study chair, University of Pecs, Medical School, Pain Medicine Dept.of Anesth Int CareBarbara Rezman, MD, Principal investigator, University of Pecs, Medical School, Dept.of Anesth Int Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527836
- Sponsor's protocol ID
- 6634
- Acronym
- PCLBAxMix
- Status last verified
- Jul 2021
- First submitted
- 15 Feb 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03527836
- Acronym / sponsor ID
- PCLBAxMix / 6634
- Conditions
- Arm Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 17 Dec 2021 (estimated)
- Study completion
- 17 Jan 2022 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine brachial plexus blockLidocaine brachial plexus block 0.4 ml/kg of 0.66% solution |
| Bupivacaine | Active comparator | Drug: Bupivacaine brachial plexus blockBupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution |
| Mixture | Active comparator | Drug: Mixture brachial plexus blockMixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine brachial plexus blockAlso: Lidocain-EGIS 1% OGYI-T-3047/03Combined Axillary-supraclavicular approach to brachial plexus with lidocaine | Drug | Lidocaine |
| Bupivacaine brachial plexus blockAlso: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine | Drug | Bupivacaine |
| Mixture brachial plexus blockAlso: Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra ZenecaCombined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1% | Drug | Mixture |
Primary outcome
Maximal plasma concentrations
Time frame: 0-8 hours
Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection
2 secondary outcomes
Onset times
Time frame: 0-0.5 hours
Duration
Time frame: 1-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Almasi, PhD. habil study chair
University of Pecs, Medical School, Pain Medicine Dept.of Anesth Int Care
Barbara Rezman, MD principal investigator
University of Pecs, Medical School, Dept.of Anesth Int Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine brachial plexus block, Bupivacaine brachial plexus block and Mixture brachial plexus block in people with Arm Injury, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal plasma concentrations (time frame: 0-8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.