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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028511
Receipt No. R000032620
Scientific Title Analgesic effects of programed intermittent bolus for the continuous quadratus lumborum block in patients undergoing laparoscopic colectomy, a prospective study
Date of disclosure of the study information 2017/08/17
Last modified on 2019/10/15

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Basic information
Public title Analgesic effects of programed intermittent bolus for the continuous quadratus lumborum block in patients undergoing laparoscopic colectomy, a prospective study
Acronym Analgesic effects of programed intermittent bolus for the continuous quadratus lumborum block, a prospective study
Scientific Title Analgesic effects of programed intermittent bolus for the continuous quadratus lumborum block in patients undergoing laparoscopic colectomy, a prospective study
Scientific Title:Acronym Analgesic effects of programed intermittent bolus for the continuous quadratus lumborum block, a prospective study
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Compare the analgesic effect of programed intermittent bolus for the continuous quadratus lumborum block in patients undergoing laparoscopic colectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes cumulative fentanyl consumption during 22h after operation
Key secondary outcomes

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
Maneuver
Interventions/Control_1 continuous infusion of quadratus lumborum block
Interventions/Control_2 programed intermittent bolus of quadratus lumborum 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 undergoing elective laparoscopic colectomy
Key exclusion criteria patients who have diabetic peripheral neuropathy
patients who use steroids or narcotic analgesic
patients who has allergy for medications to use
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 0853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shimane University Hospital, Clinical Trial Review Board
Address 89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel +81853202515
Email kenkyu@med.shimane-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 08 Month 17 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 50
Results
The primary outcome of cumulative fentanyl consumption at 22 hours showed no significant difference between the programmed intermittent bolus and continuous basal infusion. VAS at rest and while coughing, demands for rescue analgesics, and spread of cutaneous sensory blockade were similar for programmed intermittent bolus and continuous basal infusion.
Results date posted
2019 Year 05 Month 05 Day
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
2017 Year 07 Month 24 Day
Date of IRB
2017 Year 07 Month 24 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2019 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032620

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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