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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036390
Receipt No. R000041462
Scientific Title Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Date of disclosure of the study information 2019/04/04
Last modified on 2019/04/02

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Basic information
Public title Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Acronym Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Scientific Title Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Scientific Title:Acronym Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Region
Japan

Condition
Condition Acute cholecystitis
Cholelithiasis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the analgesic effects of additional of a magnesium sulfate to local anesthetic for transversus abdminis plane block in patients after laparoscopic cholecystectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numeric rating scale at 24h after operation
Key secondary outcomes Numeric rating scale at time of exit operating room
Numeric rating scale at 3, 6,12h after operation
Time when the patient first used analgesic
postoperative nausea and vomiting

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Additional of magnesium sulfate 300 mg to local anesthetics used for transversus abdminis plane block
Interventions/Control_2 Only local anesthetics are used for sciatic nerve 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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who schedulled for a laparoscopic cholecystectomy with renging from 20 to 80 years.
American Society of Anesthesiologists physical status 1-2
Key exclusion criteria Body mass index >=35
American Society of Anesthesiologists physical status >=3
dementia
renal disorder
history of a local anesthesia allergy
Neuromuscular or neurological disorder
Psychiatric problem
Coagulation disorder
history of a Hypermagnesemia
pregnant or at lactation
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Chihiro
Middle name
Last name Iwata
Organization Nayoro City General Hospital
Division name Department of Anesthesiology
Zip code 096-0042
Address 8-1 Minami, Nishi7, Nayoro-city, Hokkaido, Japan
TEL 01654-3-3101
Email kyokui100006@gmail.com

Public contact
Name of contact person
1st name Chihiro
Middle name
Last name Iwata
Organization Nayoro City General Hospital
Division name Department of Anesthesiology
Zip code 096-0042
Address 8-1 Minami, Nishi7, Nayoro-city, Hokkaido, Japan
TEL 01654-3-3101
Homepage URL
Email kyokui100006@gmail.com

Sponsor
Institute Nayoro City General Hospital
Institute
Department

Funding Source
Organization Nayoro City General Hospital
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 none
Address none
Tel none
Email none

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
2019 Year 04 Month 04 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 04 Day
Last follow-up date
2020 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
2019 Year 04 Month 02 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041462

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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