UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045480
Receipt number R000051922
Scientific Title The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-
Date of disclosure of the study information 2021/09/20
Last modified on 2023/04/13 11:31:57

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Basic information

Public title

The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-

Acronym

The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-

Scientific Title

The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-

Scientific Title:Acronym

The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-

Region

Japan


Condition

Condition

Osteoarthritis of the hip

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to compare the effect to reduce postoperative pain and nausea between intravenous patient-controlled-analgesia and oral and intravenous acetaminophen administration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

post operative pain following total hip arthroplasty at 1 day, 2 days, 4 days, and 7days after surgery.

Key secondary outcomes

post operative nausea at 1 day, 2 days, 4 days, and 7days after surgery.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

comparison of iv-PCA and acetaminophen for postoperative pain control

Interventions/Control_2

comparison of iv-PCA and acetaminophen for postoperative pain control

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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

The persons undergone total hip arthroplasty

Key exclusion criteria

The persons with liver dysfunction, renal dysfunction, revision surgery, and to refuse the participate this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Norio
Middle name
Last name Imai

Organization

Niigata University Graduate School

Division name

Div. of Comprehensive Musculoskeletal Medicine

Zip code

9518510

Address

1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture

TEL

0252272272

Email

imainorio2001@yahoo.co.jp


Public contact

Name of contact person

1st name Norio
Middle name
Last name Imai

Organization

Niigata

Division name

Div. of Comprehensive Musculoskeletal Medicine

Zip code

9518510

Address

1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture

TEL

0252272272

Homepage URL


Email

imainorio2001@yahoo.co.jp


Sponsor or person

Institute

Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Niigata University

Address

1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture

Tel

0252272272

Email

imainorio2001@yahoo.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2021-0013

Org. issuing International ID_1

Niigata University

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 09 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

190

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 09 Month 15 Day

Date of IRB

2021 Year 08 Month 03 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2023 Year 03 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 09 Month 14 Day

Last modified on

2023 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name