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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04921852
Other study ID # costoclavicular
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 7, 2021
Est. completion date October 7, 2021

Study information

Verified date June 2021
Source Ankara City Hospital Bilkent
Contact süleyman kaya
Phone +905335805066
Email slymnk06@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators aimed to compare the block dynamics and characteristics of the two approaches while providing effective analgesia and safe anesthesia of the Ultrasound-guided Lateral sagittal Infraclavicular and costoclavicular approach in Brachial plexus blocks.


Description:

Participants between the ages of 18-70 with the American Society of Anesthesiology (ASA) score I-II-III will be included in the study. All participants will be evaluated preoperatively and information will be given about the anesthetic method to be applied. Demographic data and ASA scores of the participants will be recorded. All of the participants included in the study will be taken to the regional anesthesia application room in the operating room approximately 1 hour before the operation. After standard anesthesia monitoring (electrocardiography, pulsoximetry, non-invasive blood pressure), all participants will be given an iv vascular access with a 20 or 22 G cannula from the arm that will not be operated. All blocks will be made using portable US machine and echogenic block needle. For all blocks, 20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be used. An overall (average) sensory and motor score was also calculated for every participants and at each time point assessed by averaging the VRS sensory or motor scores of all the 4 nerves will be tested preoperatively.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date October 7, 2021
Est. primary completion date September 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists physical status 1 to 3 - 18-70 age - hand , wrist , forearm and elbow surgery Exclusion Criteria: - refusal to participate, - pregnancy, - body mass index of 30 kg/m2 or greater - history of allergy to local anesthetic drugs - prior surgery over the infraclavicular fossa, - preexisting neurological deficit - coagulopathy - infection over infraclavicular fossa.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
costoclavicular brachial plexus block
A transverse scan with an portable USG machine with a high-frequency linear array transducer ((Logiq E, General Electric, ABD) will be performed immediately below the midpoint of the clavicle and over the medial infraclavicular fossa. 20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be injected in to the middle of the three brachial plexus cords with an echogenic SonoTAP(Pajunk GmbH Medizintechnologie, Geisingen, Germany) block needle under USG guidance .Readiness for surgery time will be evaluated after costoclavicular block.
lateral sagittal infraclavicular block
A sagittal scan with an portable USG machine with a high-frequency linear array transducer ((Logiq E, General Electric, ABD) will be performed medial to the coracoid process to obtain a transverse view of the axillary artery.20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be injected posterior to the axillary artery near to the three cords of brachial plexus with an echogenic SonoTAP(Pajunk GmbH Medizintechnologie, Geisingen, Germany) block needle under USG guidance.Readiness for surgery time will be evaluated after lateral sagittal infraclavicular block.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Outcome

Type Measure Description Time frame Safety issue
Primary readiness for surgery time Sensory block, defined as a loss of sensation to cold (ice), in the cutaneous distribution of the median (MN), radial (RN), ulnar (UN), and musculocutaneous (MCN) nerves will be assessed and graded according to a VRS (0-100, 100 = normal sensation and 0 = no sensation). Motor blockade of each of the 4 nerves in the ipsilateral upper extremity was also assessed and graded according to a 3-point qualitative scale (2 = normal motor power, 1 = paresis, and 0 = paralysis).Onset of sensory and motor blockade for each nerve was defined as the time (onset time) it took to achieve a sensory VRS of 30 or less and motor power grade of 1 or less, respectively.Time to readiness for surgery was defined as the time it took to achieve an overall sensory score of 30 or less and motor power grade of 1 or less, in all the 4 nerves tested. 30 minute
Secondary block performance time the time it took from the start of the local skin infiltration to the end of the local anesthetic injection 5 minute
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