UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022412
Receipt number R000019566
Scientific Title Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery
Date of disclosure of the study information 2016/05/30
Last modified on 2018/06/05 15:19:20

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Basic information

Public title

Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery

Acronym

The efficacy of local anesthesia in laparoscopic surgery

Scientific Title

Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery

Scientific Title:Acronym

The efficacy of local anesthesia in laparoscopic surgery

Region

Japan


Condition

Condition

Gynecological tumor

Classification by specialty

Obstetrics and Gynecology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study of the effect of the post-operative pain control of local anesthesia in gynecological laparoscopic surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The amount of postoperative analgesics

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Injection of local anesthesia into the wound

Interventions/Control_2

Injection of saline to the wound

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

90 years-old >=

Gender

Female

Key inclusion criteria

Patients with laparoscopic surgery scheduled for gynecological benign disease and endometrial cancer

Key exclusion criteria

using the epidural anesthesia

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Shimoya

Organization

Kawasaki Medical School

Division name

Department of Obstetrics and Gynecology

Zip code


Address

577Mathusima Kurashiki city Okayama Prefecture

TEL

0864621111

Email

gyne@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mika Sugihara

Organization

Kawasaki Medical School

Division name

Department of Obstetrics and Gynecology

Zip code


Address

577Mathusima Kurashiki city Okayama Prefecture

TEL

0864621111

Homepage URL


Email

gyne@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

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


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

2016 Year 05 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

Completed

Date of protocol fixation

2015 Year 08 Month 14 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 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

2016 Year 05 Month 23 Day

Last modified on

2018 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name