UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024840
Receipt No. R000028586
Scientific Title Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery
Date of disclosure of the study information 2017/02/01
Last modified on 2019/05/19

* 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 Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery
Acronym Efficacy of Abdominal peripheral nerve block for surgical space condition
Scientific Title Efficacy of Abdominal peripheral nerve block for Surgical space condition during robotic assisted laparoscopic surgery
Scientific Title:Acronym Efficacy of Abdominal peripheral nerve block for surgical space condition
Region
Japan

Condition
Condition Prostate cancer, Bladder cancer
Classification by specialty
Urology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether to improve surgical space condition with abdominal peripheral nerve block
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in depth of the abdominal cavity
Key secondary outcomes Surgeon's evaluation for surgical space condition
Objective Evaluation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 Only total intravenous anesthesia (Control Group)
Interventions/Control_2 Added to peripheral nerve block by local anesthetics(Bock Group)
Peripheral nerve block is performed only one time after induction.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)ASA 1-2
2)Elective robotic assisted laparoscopic surgery
Key exclusion criteria 1)Known allergy to local anesthetics
2)Known allergy to neuromuscular relaxant or neuromuscular antagonist
3)Liver and renal imparement
4)Difficulty of peripheral nerve block performance
5)BMI >= 30
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Noguchi
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 036-8562
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-39-5113
Email satko1110@yahoo.co.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Noguchi
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 036-8562
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-39-5113
Homepage URL
Email satko1110@yahoo.co.jp

Sponsor
Institute Hirosaki University Hospital of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
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 Hirosaki University Hospital of Medicine
Address 53 Hon-cho, Hirosaki, Aomori
Tel 0172-39-5295
Email cksenta@hirosaki-u.ac.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
2017 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
2016 Year 12 Month 14 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2021 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
2016 Year 11 Month 15 Day
Last modified on
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.