UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024815
Receipt No. R000028528
Scientific Title Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Date of disclosure of the study information 2016/12/01
Last modified on 2019/03/15

* 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 Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Acronym Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy
Scientific Title Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Scientific Title:Acronym Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy
Region
Japan

Condition
Condition gallbladder disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this research is making it clear which anesthesia of a rectus sheath block procedure and the local infiltration anesthesia is superior for postoperative pain after laparoscopic cholecystectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain evaluation with VAS at the first day after surgery
Key secondary outcomes

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 rectus sheath block group
Interventions/Control_2 local infiltration anesthesia group
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 Male and Female
Key inclusion criteria The patients who have an electively operation of laparoscopic cholecystectomy for the benign gallbladder disease and who agree to this study
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naomi
Middle name
Last name Kitamura
Organization Shiga University of Medical Science
Division name department of surgery
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL 077-548-2238
Email naomik@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Kitamura
Organization Shiga University of Medical Science
Division name department of surgery
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL 077-548-2238
Homepage URL
Email naomik@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
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 SUMS Research Ethics Committee
Address Seta Tsukinowa cho, Otsu city, Shiga Pref.
Tel 077-548-3576
Email hqrec@belle.shiga-med.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
2016 Year 12 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 62
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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
2016 Year 11 Month 07 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 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 12 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.