UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032226 |
|---|---|
| Receipt number | R000034783 |
| Scientific Title | Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial. |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2020/01/06 15:11:49 |
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Basic information
Public title
Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial.
Acronym
Intramuscular quadratus lumborum block after total laparoscopic hysterectomy.
Scientific Title
Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial.
Scientific Title:Acronym
Intramuscular quadratus lumborum block after total laparoscopic hysterectomy.
Region
| Japan |
Condition
Condition
Adults patients scheduled for total laparoscopic surgery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of intramuscular quadratus lumborum block after total laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
opioid consumption after 24 hours after surgery
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Itervention
intramuscular quadratus lumblorum block(0.25% levobupivacain)
Interventions/Control_2
cotrol
intramuscular quadratus lumblorum block(saline)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
ASA physical status 1 and 2 adult patients scheduled for total laparoscopic hysterectomy at Yokohama City University Hospital
Key exclusion criteria
Patients with cognitive dysfunction, obesity(BMI>=35),renal dysfunction(eGFR<=50), drug allergy for NSAIDs,acetaminophen,local anesthetic, gastric ulcer
Pregnant or suspected pregnant patients
Pre-operative regular use of opioids or steroids
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Fujimoto |
Organization
Yokohama City University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
TEL
0457872800
pochipochi_7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Fujimoto |
Organization
Yokohama City University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
TEL
0457872800
Homepage URL
pochipochi_7@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University School of Medicine. Department of Anesthesiology and Critical Care Medicine.
Institute
Department
Personal name
Funding Source
Organization
no
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
Yokohama City University School of Medicine
Address
3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
Tel
0457872800
onodera@yokohama-cu.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
| 2018 | Year | 04 | Month | 13 | 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
0
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034783
