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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014746
Receipt No. R000016945
Scientific Title Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Date of disclosure of the study information 2014/08/01
Last modified on 2017/02/20

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Basic information
Public title Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Acronym Efficiency and safety of laparoscopic reutus shaeth block
Scientific Title Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Scientific Title:Acronym Efficiency and safety of laparoscopic reutus shaeth block
Region
Japan

Condition
Condition Regional anesthesia in gynecologic laparoscopy
Classification by specialty
Surgery in general Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our aim is to evaluate the efficiency and the safety of laparoscopic regional anesthesia for abdominal wall in laparoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Evaluating postoperative pain at 6 hour, 12hour and postoperative days1-3 by Wong-Baker pain scale .
Key secondary outcomes Evaluating the number of postoperative analgesics.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Patients randomly are assigned with a 1:1 ratio to receive injection or not. Control group have no regional anesthesia and prescribe oral medicine, suppository and intramuscular injection of analgesics.
Interventions/Control_2 Patients randomly are assigned with a 1:1 ratio to receive injection or not. Injection group are injected regional anesthetic onto peritoneum in laparoscopy under general anesthesia. This group can also receive analgesics.
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

Not applicable
Gender Female
Key inclusion criteria 1)Patients scheduling to undergo benign gynecologic laparoscopy
2)Female patients older than 19 years
3)Patients who approve our research program and write informed consent
Key exclusion criteria 1)Patients weighing less than 50kg
2)Patients with severe disorder of liver function
3)Patients on chronic hemodialysis
4)Patients with clotting abnormality
5)Patients taking anticoagulant and antiplatelet
6)Patients with diabetes mellitus and multiple sclerosis
7)Patients with allergy for regional anesthetic
8)Patients scheduling to undergo single-incision laparoscopy
9)Patients with any difficulty in regional anesthesia
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Hachisuga
Organization University of Occupational Environmental Health, Japan
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
TEL 093-603-1611
Email thachisu@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Kinjo
Organization University of Occupational Environmental Health, Japan
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
TEL 093-603-1611
Homepage URL
Email kinjo-yasuyuki@med.uoeh-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, University of Occupational Environmental Health, Japan
Institute
Department

Funding Source
Organization none
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 産業医科大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 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 Completed
Date of protocol fixation
2014 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 02 Month 20 Day
Date analysis concluded
2017 Year 02 Month 20 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 01 Day
Last modified on
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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