NCT04757896

Brief Summary

To evaluate the success of surgical anesthesia of lateral and medial approaches of the costoclavicular block in patients undergoing upper extremity surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

February 1, 2021

Last Update Submit

April 28, 2021

Conditions

Anesthesia

Keywords

brachial plexus block

Outcome Measures

Primary Outcomes (1)

  • success in providing surgical anesthesia via triple point scale evaluation

    The triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes.

    30 minutes

Secondary Outcomes (1)

  • Initiation time of block

    30 minutes

Study Arms (2)

Costoclavicular block lateral aproach

ACTIVE COMPARATOR

An 80-100 mm needle will be directed from the lateral to the medial with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting

Procedure: Lateral costoclavicular approach

Costoclavicular block medial aproach

ACTIVE COMPARATOR

An 80-100 mm needle will be directed from the medial to the lateral with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting

Procedure: Medial costoclavicular approach

Interventions

Lateral costoclavicular approachPROCEDURE

USG guided lateral costoclavicular approach for brachial plexus block

Costoclavicular block lateral aproach
Medial costoclavicular approachPROCEDURE

USG guided medial costoclavicular approach for brachial plexus block

Costoclavicular block medial aproach

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective or emergency upper limb surgery
  • Between 18 to 80 years old
  • ASA I-IV

You may not qualify if:

  • \<18 years old/ \>80 Years old
  • \>ASA IV
  • Any serious illness
  • Anticoagulant/antiaggregate treatments
  • Any allergies to the drugs that used in study
  • İnfections or open wounds at the operation area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

Related Publications (3)

  • Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

    PMID: 25899958BACKGROUND

  • Nieuwveld D, Mojica V, Herrera AE, Pomes J, Prats A, Sala-Blanch X. Medial approach of ultrasound-guided costoclavicular plexus block and its effects on regional perfussion. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):198-205. doi: 10.1016/j.redar.2016.09.010. Epub 2016 Dec 9. English, Spanish.

    PMID: 27938934BACKGROUND

  • Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.

    PMID: 28205117BACKGROUND

Study Officials

  • ataturk unıversity

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
blind surgeon and investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr. İlker İNCE

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 17, 2021

Study Start

December 25, 2020

Primary Completion

March 30, 2021

Study Completion

April 28, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

TU(1)