UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020740 |
|---|---|
| Receipt number | 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 12:47:20 |
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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
| Obstetrics 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
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
yyoshiff@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Aichi medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022462
