NCT03097159

Brief Summary

The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

March 26, 2017

Last Update Submit

July 1, 2018

Conditions

Phrenic Nerve Paralysis

Keywords

costoclavicular block

Outcome Measures

Primary Outcomes (1)

  • Diaphragm palsy

    Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25\~75% movement Normal : reduced less than 25%

    30 min

Study Arms (2)

Costoclavicular block

For anesthesia, this group of patients will be received ultrasound guided costoclavicular block

Procedure: Costoclavicular block

Supraclavicular block

For anesthesia, this group of patients will be received ultrasound guided supraclavicular block

Interventions

Costoclavicular blockPROCEDURE

Group C for costoclavicular block Group S for supraclavicular block

Costoclavicular block

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for surgery of hand or forearm

You may qualify if:

  • ASA I or II
  • Scheduled for surgery of hand or forearm

You may not qualify if:

  • Patient refusal
  • Neuromuscular disease
  • Pregnancy
  • Previous history of surgery of periclavicular region
  • Nerve injury history
  • Bleeding tendency
  • Allergy to local anesthetics
  • Other contraindication of regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16377, South Korea

Location

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

March 26, 2017

First Posted

March 31, 2017

Study Start

May 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

July 3, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)