UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035443
Receipt number R000040372
Scientific Title Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Date of disclosure of the study information 2020/01/04
Last modified on 2020/07/06 10:38:18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.

Acronym

Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.

Scientific Title

Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.

Scientific Title:Acronym

Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.

Region

Japan


Condition

Condition

Patient who undergoing shoulder arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To Compare the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block with interscalene block in patients who undergoing shoulder arthroplasty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Post-operative pain(Visual analog scale, Numerical rating scale)

Key secondary outcomes

Duration of anesthesia, the use of rescue analgesia, the frequency of nausea and vomiting, the presence of respiratory distress, the presence of paresthesia, other nerve block complication, post-operative shoulder flexion angle, evaluation of strength of elbow flexion and extension using Manual Muscle Testing (MMT), grip strength.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Supurascapular nerve block and axillary nerve block

Interventions/Control_2

Interscalene block

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing primary hemiarthroplasty, total shoulder arthroplasty, reverse total shoulder arthroplasty.

Key exclusion criteria

The case where no preoperative consent is obtained.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Yasuhara
Middle name
Last name Arashiro

Organization

Fukuoka University Faculty of Medicine

Division name

Dept.of Orthop.Surg

Zip code

8140180

Address

7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan

TEL

092-801-1011

Email

md180001@cis.fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Yasuhara
Middle name
Last name Arashiro

Organization

Fukuoka University Faculty of Medicine

Division name

Dept.of Orthop.Surg

Zip code

8140180

Address

7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan

TEL

092-801-1011

Homepage URL


Email

md180001@cis.fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka University

Address

7-45-1 Nanakuma Jonan-ku, Fukuoka-shi, Fukuoka-ken

Tel

0928011011

Email

fumed-ethics@fukuoka-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 04 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

4

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

Terminated

Date of protocol fixation

2019 Year 01 Month 04 Day

Date of IRB

2019 Year 03 Month 06 Day

Anticipated trial start date

2019 Year 01 Month 09 Day

Last follow-up date

2020 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 04 Day

Last modified on

2020 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name