UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043129
Receipt number R000049236
Scientific Title A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Date of disclosure of the study information 2021/01/25
Last modified on 2022/12/11 18:59:39

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Basic information

Public title

A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty

Acronym

A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty

Scientific Title

A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty

Scientific Title:Acronym

A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty

Region

Japan


Condition

Condition

Patients for total hip arthroplasty

Classification by specialty

Orthopedics Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the efficacy of postoperative lumbar plexus block in relieving postoperative pain in patients undergoing hip replacement surgery by randomly assigning them to a group with or without lumbar plexus block.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain at rest and during movement will be assessed by NRS and compared at 30 minutes, 2 hours, 5 hours, 11 hours, the morning of the first postoperative day, and the morning of the second postoperative day after returning to the ward.

Key secondary outcomes

Presence or absence of motor paralysis and PONV at 30 minutes, 2 hours, 5 hours, 11 hours after returning to the ward, on the morning of the first postoperative day, and on the morning of the second postoperative day, number of times of antiemetic use,number of times rescue was used and time to first use, and patient satisfaction with pain


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Postoperative lumbar plexus block with 20 ml of 0.15% levobupivacaine in patients undergoing hip replacement surgery.

Interventions/Control_2

No postoperative lumbar plexus block in patients undergoing hip replacement 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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

ASA-PS 1 or 2

Key exclusion criteria

ASA-PS 3 or higher, not a single operation (e.g. bilateral THA), unobserved withdrawal of antiplatelet/anticoagulant medication, patients with hepatic or renal dysfunction, patients with dementia, patients with allergy to local anesthetics, preoperative opioid use

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yugo
Middle name
Last name Ono

Organization

Itabashi Chuo Medical Center

Division name

Department of Anesthesiology

Zip code

174-0051

Address

2-12-7, Azusawa, Itabashi-ku, Tokyo

TEL

03-3967-1181

Email

yugo1201@yahoo.co.jp


Public contact

Name of contact person

1st name Yugo
Middle name
Last name Ono

Organization

Itabashi Chuo Medical Center

Division name

Department of Anesthesiology

Zip code

174-0051

Address

2-12-7, Azusawa, Itabashi-ku, Tokyo

TEL

03-3967-1181

Homepage URL


Email

yugo1201@yahoo.co.jp


Sponsor or person

Institute

Itabashi Chuo Medical Center

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

Itabashi Chuo Medical Center

Address

2-12-7, Azusawa, Itabashi-ku, Tokyo

Tel

03-3967-1181

Email

ikyokuhisyo.ibh@ims.gr.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

2021 Year 01 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

Completed

Date of protocol fixation

2020 Year 12 Month 22 Day

Date of IRB

2020 Year 12 Month 22 Day

Anticipated trial start date

2020 Year 12 Month 22 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 25 Day

Last modified on

2022 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name