The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Block
1 other identifier
interventional
46
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2021
CompletedStudy Start
First participant enrolled
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2021
CompletedJune 10, 2021
June 1, 2021
3 months
May 30, 2021
June 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
block performance time
5 minute
Study Arms (2)
costoclavicular group
ACTIVE COMPARATORlateral sagittal group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status 1 to 3
- age
- hand , wrist , forearm and elbow surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
May 30, 2021
First Posted
June 10, 2021
Study Start
June 7, 2021
Primary Completion
September 7, 2021
Study Completion
October 7, 2021
Last Updated
June 10, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share