UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032735
Receipt number R000037318
Scientific Title Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Date of disclosure of the study information 2018/05/28
Last modified on 2023/12/10 12:43:28

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Basic information

Public title

Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.

Acronym

Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.

Scientific Title

Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.

Scientific Title:Acronym

Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.

Region

Japan


Condition

Condition

Patients scheduled for elective laparoscopic hepatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to compare the effects of analgesia for patients scheduled for elective laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MPADSS(modified post-anaesthesia discharge scoring system)scores for the first 42 postoperative hours.

Key secondary outcomes

Pain scores at rest and while coughing for the first 42 postoperative hours.
Additional analgesics.
The number of PCA bolus.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Epidural analgesia after laparoscopic hepatectomy

Interventions/Control_2

Continuous intravenous fentanyl analgesia after laparoscopic hepatectomy

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Man and women over 20year old
Patients scheduled for laparoscopic hepatectomy

Key exclusion criteria

Open hepatectomy
Decision as ineligible by principal anaesthesiologist.
Patients with parkinson disease.
Contraindication for any of the drugs used in this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Azusa
Middle name
Last name Mori

Organization

Ikeda City Hospital

Division name

Department of Anesthesiology

Zip code

5638510

Address

3-1-18,Jyonan,Ikeda City ,Osaka,Japan

TEL

0727512881

Email

azuazumorimori@yahoo.co.jp


Public contact

Name of contact person

1st name Azusa
Middle name
Last name Mori

Organization

Ikeda City Hospital

Division name

Department of Anesthesiology

Zip code

5638510

Address

3-1-18,Jyonan,Ikeda City ,Osaka,Japan

TEL

0727512881

Homepage URL


Email

azuazumorimori@yahoo.co.jp


Sponsor or person

Institute

Ikeda City Hospital

Institute

Department

Personal name



Funding Source

Organization

Ikeda City Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Ikeda City Hospital

Address

3-1-18,Jyonan,Ikeda City ,Osaka,Japan

Tel

0727512881

Email

keiko-irishio@hosp.ikeda.osaka.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

2018 Year 05 Month 28 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

46

Results

MPADSS score were similar among two groups

Results date posted

2023 Year 01 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients scheduled for elective laparoscopic hepatectomy

Participant flow

We prospectively evaluated the effect of intravenous fentanyl analgesia with preoperatively single nerve block(n19)compared with the effect of epidural analgesia(n18)   

Adverse events

none

Outcome measures

the score of MPADSS(modified
post-anesthesia discharge scoring system) after surgery

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 05 Month 29 Day

Date of IRB

2018 Year 05 Month 01 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 27 Day

Last modified on

2023 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name