UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019124
Receipt number R000021975
Scientific Title Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.
Date of disclosure of the study information 2015/09/30
Last modified on 2015/09/26 22:00:20

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Basic information

Public title

Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.

Acronym

Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.

Scientific Title

Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.

Scientific Title:Acronym

Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.

Region

Japan


Condition

Condition

patients who undergo on posterior spinal fusion for degenerative spine disease and spinal trauma

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the efficacy of IV-PCA for the management of postoperative pain

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual analogue scale in patients one hour after surgery and postoperative day one

Key secondary outcomes

complications and usage of non-opioid analgesics


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

usage of IVPCA after surgery for up to 100 hours

Interventions/Control_2

non-usage of IVPCA

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

patients undergoing elective posterior spinal fusion and general anesthesia

Key exclusion criteria

patients who have history of psychiatric disorder, cannot press the button of IVPCA

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiya Tomioka

Organization

Saitama Red Cross Hospital

Division name

Anesthesia

Zip code


Address

Kamiochiai 8-3-33 Chuo-ku Saitama city Saitama Japan

TEL

048-852-1111

Email

mmarico04@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiya Tomioka

Organization

Saitama Red Cross Hospital

Division name

Anesthesia

Zip code


Address

Kamiochiai 8-3-33 Chuo-ku Saitama city Saitama Japan

TEL

048-852-1111

Homepage URL


Email

mmarico04@yahoo.co.jp


Sponsor or person

Institute

Saitama Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Saitama Red Cross Hospital

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 09 Month 30 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

Preinitiation

Date of protocol fixation

2015 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 09 Month 26 Day

Last modified on

2015 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name