UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034559
Receipt number R000039400
Scientific Title Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial
Date of disclosure of the study information 2018/10/20
Last modified on 2023/04/22 09:11:54

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Basic information

Public title

Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial

Acronym

Comparison of selective tibial nerve block and IPACK block

Scientific Title

Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial

Scientific Title:Acronym

Comparison of selective tibial nerve block and IPACK block

Region

Japan


Condition

Condition

Total knee arthroplasty

Classification by specialty

Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assess the analgesic efficacy of selective tibial nerve block and IPACK block in patients undergoing TKA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. VAS score
2. Range of movoment
3. Rescue consumption

Key secondary outcomes



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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Selective tibial nerve block 0.375% ropivacaine 5mL

Interventions/Control_2

IPACK block 0.375% ropivacaine 20mL

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

40 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1. Ostoarthritis of unilateral knee.
2. The patients who agreed the informed consent of participation in this study.

Key exclusion criteria

Subjects were excluded if they were younger than 40-yr or older than 90-yr, had a history of allergy to local anesthetics, had a neurological disorder affecting the corresponding region, using opioids or steroids.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Ohgoshi

Organization

Keiyu Hospital

Division name

Department of Anesthesiology

Zip code

220-8521

Address

3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan

TEL

045-221-8181

Email

ohgoshi22@gmail.com


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Ohgoshi

Organization

Keiyu Hospital

Division name

Department of Anesthesiology

Zip code

220-8521

Address

3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan

TEL

045-221-8181

Homepage URL


Email

ohgoshi22@gmail.com


Sponsor or person

Institute

Keiyu Hospital

Institute

Department

Personal name



Funding Source

Organization

None.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keiyu Hospital

Address

3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan

Tel

045-221-8181

Email

ohgoshi22@gmail.com


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

2018 Year 10 Month 20 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


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

2018 Year 10 Month 20 Day

Date of IRB

2018 Year 10 Month 15 Day

Anticipated trial start date

2018 Year 10 Month 20 Day

Last follow-up date

2022 Year 10 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 18 Day

Last modified on

2023 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name