NCT04102358

Brief Summary

Theoretically, all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to clinical anesthesia, plexus, and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success and low risk of complications (1). In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

October 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

September 23, 2019

Last Update Submit

February 16, 2024

Conditions

Keywords

Vertical infraclavicular blockbrachial plexus anatomy

Outcome Measures

Primary Outcomes (1)

  • Supplemented blocks

    30 minutes after the block, if one or two of the median, radial, ulnar or musculocutaneous nerves were still unblocked, these nerves were located either with a peripheric nerve stimulator or an ultrasound, in the axilla or on the more distal parts of their traces on arm and forearm and then supplemented.

    1 hour

Secondary Outcomes (4)

  • Complete Failure

    30 minutes

  • Recovery of sensory block

    24 hours

  • Discomfort during IC block

    1 hour

  • Inadvertent vascular puncture

    1 hour

Study Arms (2)

Single injection

Patients who received an infraclavicular block with a single injection technique were included in Group-S.

Procedure: Medial approach infraclavicular block with single injection

Triple injection

Patients who received an infraclavicular block with a triple injection technique were included in Group-T.

Procedure: Medial approach infraclavicular block with triple injection

Interventions

infraclavicular blocks performed with single injection

Single injection

infraclavicular blocks performed with triple injection

Triple injection

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019

You may qualify if:

  • ASA physical status I-III
  • upper extremity surgery
  • blocks were performed by the same anesthesiologist

You may not qualify if:

  • non-cooperative patients
  • refusal of the regional anesthesia
  • known neuropathy
  • different technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.)
  • known allergy to local anesthetic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, Derince, 41900, Turkey (Türkiye)

Location

Related Publications (3)

  • Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.

    PMID: 19174373BACKGROUND
  • Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.

    PMID: 28157792BACKGROUND
  • Kilka HG, Geiger P, Mehrkens HH. [Infraclavicular vertical brachial plexus blockade. A new method for anesthesia of the upper extremity. An anatomical and clinical study]. Anaesthesist. 1995 May;44(5):339-44. doi: 10.1007/s001010050162. German.

    PMID: 7611581BACKGROUND

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Tuncay Colak, Prof

    Kocaeli University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

October 1, 2017

Primary Completion

March 31, 2019

Study Completion

May 30, 2019

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available within 6 months of study completion.
Access Criteria
Data access requests will be reviewed by the researchers. Requestors will be required to sign a Data Access Agreement.

Locations