- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04921852
The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Block
The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Approach in Brachial Plexus Blocks
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: süleyman kaya
- Phone Number: +905335805066
- Email: slymnk06@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: costoclavicular group
|
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.
|
|
Active Comparator: lateral sagittal group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
readiness for surgery time
Time Frame: 30 minute
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
block performance time
Time Frame: 5 minute
|
the time it took from the start of the local skin infiltration to the end of the local anesthetic injection
|
5 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- costoclavicular
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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