UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043880
Receipt number R000050104
Scientific Title A comparison of anesthetic quality and complication between single injection and double injection of costoclavicular approach in upper extremity surgery
Date of disclosure of the study information 2021/04/09
Last modified on 2021/07/03 08:43:47

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Basic information

Public title

A comparison of anesthetic quality and complication between single injection and double injection of costoclavicular approach in upper extremity surgery

Acronym

single vs. double costoclavicular approach

Scientific Title

A comparison of anesthetic quality and complication between single injection and double injection of costoclavicular approach in upper extremity surgery

Scientific Title:Acronym

single vs. double costoclavicular approach

Region

Asia(except Japan)


Condition

Condition

upper extreimity surgery

Classification by specialty

Orthopedics Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

costoclavicular block is one type of infraclavicular brachial plexus block, which offers advantages as a single-injection BPB for upper extremity surgery.
We want to compare the block quality and complication between single vs. double injections in the costoclavicular approach

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

success rate (excellent, insufficient, fail)
the rate of blockage of all four nerves

Key secondary outcomes

the onset time (time required to obtain a full sensory block at the surgical incision site)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Interventions: double injection of costoclavicular approach
21G, 68mm E-cath needle (Pajunk)
Nerve stimulator
GE ultrasound

Interventions/Control_2

Control: single injection of costoclavicular approach

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

19 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

all patients anticipating upper extremity surgery, age: 19 to 80 years, American Society of Anesthesiologists physical status (ASA)I to III

Key exclusion criteria

neuropathy in the operated limb, coagulation disorders, known allergy to local anesthetics, local infection at the puncture site, chronic obstructive pulmonary disease or respiratory failure, pregnancy or breast feeding,prior surgery in the supraclavicular region, obesity, uncooperative patients, patients' refusal

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Mi Geum
Middle name
Last name Lee

Organization

Gachon University Gil Medical Center

Division name

Department of Anesthesiology and Paind medicine

Zip code

21565

Address

Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, South Korea

TEL

82-32-460-3636

Email

mikeum2@gilhospital.com


Public contact

Name of contact person

1st name Hyeon Ju
Middle name
Last name Shin

Organization

Korea University College of Medicine, Anam hospital

Division name

The Anesthesiology and Pain medicine

Zip code

136-705

Address

Department of Anesthesiology and Pain Medicine, College of Medicine, Korea University Address: #73 G

TEL

+82-2-2286-1259

Homepage URL


Email

may335@naver.com


Sponsor or person

Institute

Korea University Anam Hospital
Gachon University Gil Medical Center

Institute

Department

Personal name



Funding Source

Organization

Korea University Anam Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Korea University College of Medicine, Anam hospital

Address

Department of Anesthesiology and Pain Medicine, College of Medicine, Korea University Address: #73 G

Tel

+82-2-2286-1259

Email

may335@naver.com


Secondary IDs

Secondary IDs

YES

Study ID_1

IRB number- 2021AN0150

Org. issuing International ID_1

Korea University College of Medicine, Anam hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

Korea University College of Medicine, Anam hospital


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

68

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 03 Month 22 Day

Date of IRB

2021 Year 03 Month 22 Day

Anticipated trial start date

2021 Year 04 Month 19 Day

Last follow-up date

2021 Year 06 Month 18 Day

Date of closure to data entry

2021 Year 06 Month 18 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 09 Day

Last modified on

2021 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name