Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]
- Conditions
- Arm Injury
- Interventions
- Drug: Mixture brachial plexus block
- Registration Number
- NCT03527836
- Lead Sponsor
- University of Pecs
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine Lidocaine brachial plexus block Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution Mixture Mixture brachial plexus block Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution Bupivacaine Bupivacaine brachial plexus block Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution
- Primary Outcome Measures
Name Time Method Maximal plasma concentrations 0-8 hours Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection
- Secondary Outcome Measures
Name Time Method Duration 1-24 hours Duration of actions of local anesthetics
Onset times 0-0.5 hours Onset times of local anesthetics
Trial Locations
- Locations (1)
University of Pécs, Medical School
🇭🇺Pécs, Baranya, Hungary