NCT04921852

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Status
unknown

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

Completed
8 days until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

May 30, 2021

Last Update Submit

June 4, 2021

Conditions

Keywords

costoclavicular blockLateral sagittal Infraclavicular blockbrachial plexus blockblock onset time

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 COMPARATOR
Procedure: costoclavicular brachial plexus block

lateral sagittal group

ACTIVE COMPARATOR
Procedure: lateral sagittal infraclavicular block

Interventions

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.

costoclavicular 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.

lateral sagittal group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

süleyman kaya

CONTACT

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