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

Arm Injury Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03527836
• Other study ID #: 6634
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: January 17, 2022

Study information

• Verified date: July 2021
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 17, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 a?ecting the brachial plexus.

Related Conditions & MeSH terms

• Arm Injuries
• Arm Injury

Intervention

Drug:
• Lidocaine brachial plexus block
Combined Axillary-supraclavicular approach to brachial plexus with lidocaine
• Bupivacaine brachial plexus block
Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine
• 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%

Locations

Country	Name	City	State
Hungary	University of Pécs, Medical School	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal plasma concentrations	Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection	0-8 hours
Secondary	Onset times	Onset times of local anesthetics	0-0.5 hours
Secondary	Duration	Duration of actions of local anesthetics	1-24 hours