UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022729
Receipt number R000026183
Scientific Title A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia
Date of disclosure of the study information 2016/06/15
Last modified on 2016/09/19 01:35:08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia

Acronym

A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Alalgesia

Scientific Title

A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia

Scientific Title:Acronym

A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Alalgesia

Region

Japan


Condition

Condition

gynecologic laparoscopic surgery

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to compare transverse abdominal plane block and rectus sheath block in terms of effectiveness for postoperative analgesia after gynecologic laparoscopic surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual analog scale scores recorded at 2,6,12 amd 24h after surgery

Key secondary outcomes

frequency of analgesic used after surgery


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Ultrasound guided transverse abdominal plane block

Interventions/Control_2

Ultrasound guided rectus sheath block

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

70 years-old >=

Gender

Female

Key inclusion criteria

1)Scheduled operation of gynecologic laparoscopic surgery
2)Written informed concent

Key exclusion criteria

1)Emergency surgery
2)Abdominal surgery
3)Allergy of study medicine

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yusuke Shimakawa

Organization

Saga-Ken medical centre koseikan

Division name

anesthesiology

Zip code


Address

400, Nakabaru,Kase,Saga,Japan

TEL

0952242171

Email

shimakawa-y@koseikan.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Shimakawa

Organization

Saga-Ken medical centre koseikan

Division name

anesthesiology

Zip code


Address

400,Nakabaru,Kase,Saga,Japam

TEL

0952242171

Homepage URL


Email

shimakawa-y@koseikan.jp


Sponsor or person

Institute

Saga-Ken medical centre koseikan

Institute

Department

Personal name



Funding Source

Organization

Saga-Ken medical centre koseikan

Organization

Division

Category of Funding Organization

Local Government

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 06 Month 15 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

2016 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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

2016 Year 06 Month 14 Day

Last modified on

2016 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name