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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020740
Receipt No. R000022462
Scientific Title The efficacy of programed intermittent bolus for the continuous quadratus lumborum block
Date of disclosure of the study information 2016/02/01
Last modified on 2020/01/29

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Basic information
Public title The efficacy of programed intermittent bolus for the continuous quadratus lumborum block
Acronym PIB for continuous QL block
Scientific Title The efficacy of programed intermittent bolus for the continuous quadratus lumborum block
Scientific Title:Acronym PIB for continuous QL block
Region
Japan

Condition
Condition gynecologic laparotomy
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the efficacy of programed intermittent bolus infusion of local anesthetics for the quadratus lumborum block.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Numerical score of postoperative pain(1,6,10.22.34.46hours after end of surgery)
Key secondary outcomes Total dose of postoperative fentanyl consumption
Postoperative adverse effect
The area of hypesthesia on the abdominal wall after surgery
Serum concentration of the local anesthetic

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 Programed intermittent bolus infusion of local anesthetic
Interventions/Control_2 Continuous infusion of local anesthetic
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
30 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria Gynecologic patients undergoing lower laparotomy with ASA PS 1-2, height 145-165cm, and BMI 20-30.
Key exclusion criteria Diabetes neuropathy
Patients with nervous disease
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Fujiwara
Organization Aichi Medical University
Division name Department of anesthesiology
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute-shi
TEL 0561-62-3311
Email yyoshiff@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Fujiwara
Organization Aichi Medical University
Division name Department of anesthesiology
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute-shi
TEL 0561-62-3311
Homepage URL
Email yyoshiff@aichi-med-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Aichi medical university
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 Aichi Medical University
Address 1-1 Yazakokarimata, Nagakute-shi
Tel 0561623311
Email atsushih@aichi-med-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 島根医科大学病院(島根県)、東北大学病院(宮城県)、香川大学病院(香川県)、旭川医科大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 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
2015 Year 10 Month 22 Day
Date of IRB
2016 Year 04 Month 27 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 26 Day
Last modified on
2020 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022462

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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