UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035982
Receipt number R000040984
Scientific Title The compariosn of the clinical effect between epidural analgesia and lumbar plexus block for postoperative analgesia of total hip arthroplasty
Date of disclosure of the study information 2019/02/25
Last modified on 2023/02/26 09:03:07

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Basic information

Public title

The compariosn of the clinical effect between epidural analgesia and lumbar plexus block for postoperative analgesia of total hip arthroplasty

Acronym

The compariosn of the clinical effect between epidural analgesia and lumbar plexus block for postoperative analgesia of total hip arthroplasty

Scientific Title

The compariosn of the clinical effect between epidural analgesia and lumbar plexus block for postoperative analgesia of total hip arthroplasty

Scientific Title:Acronym

The compariosn of the clinical effect between epidural analgesia and lumbar plexus block for postoperative analgesia of total hip arthroplasty

Region

Japan


Condition

Condition

patients scheduled for total hip arthroplasty

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The comparison of the clinical effect between epidural analgesia and lumbar plexus block for the postoperative analgesia in patinets scheduled for toral hip arthroplasty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The severity of hip pain (Numerical rating scale) when loading to ipsilateral leg and transferring to the wheelshair on the next day after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) 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

The administration of the epidural analgesia or lumbar plexus block in the patients scheduled for total hip arthroplasty

Interventions/Control_2

the next day after surgery

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

ASA physical status I or II

Key exclusion criteria

The allergy of local analgesics, the usage of opioids in the preoperative period, hemorrhagic

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Sawada

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code

0608543

Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido

TEL

0116112111

Email

atusihon7@gmail.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Sawada

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code

0608543

Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido

TEL

0116112111

Homepage URL


Email

atusihon7@gmail.com


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

No sourve of funding

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

Sapporo Medical University School of Medicine

Address

South 1, West 16, Chuo-ku

Tel

0116112111

Email

atusihon7@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

2019 Year 02 Month 25 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

Terminated

Date of protocol fixation

2019 Year 02 Month 22 Day

Date of IRB

2019 Year 02 Month 05 Day

Anticipated trial start date

2019 Year 02 Month 22 Day

Last follow-up date

2021 Year 08 Month 26 Day

Date of closure to data entry

2023 Year 02 Month 26 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 23 Day

Last modified on

2023 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040984


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name