UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030912 |
|---|---|
| Receipt number | R000035297 |
| Scientific Title | Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2019/08/09 12:49:32 |
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Basic information
Public title
Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Acronym
Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Scientific Title
Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Scientific Title:Acronym
Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Region
| Japan |
Condition
Condition
Total laparoscopic hysterectomy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the analgesic effects and dermatomal spread after quadratus lumborum block in patients after total laparoscopic hysterectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue pain scale at 24 hour after block
Key secondary outcomes
postoperative opioid and other analgesic consumption
Dermatomal sensory spread
postoperative nausea and vomitting
complication related block
concentration and volume of local anesthetic for quadratus lumborum block
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
Scheduled for total laparoscopic hysterectomy
American Society of Anesthesiologists physical status 1~3
Written informed concent for the study
Key exclusion criteria
Allergy to study medication
Preoperative use of opioids and steroids
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
81-853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
81-853-20-2295
Homepage URL
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine, Department of Anesthesiology
Institute
Department
Personal name
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
0853-20-2515
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
| 2018 | Year | 01 | Month | 24 | 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
40
Results
No significant difference was observed in postoperative pain scores, demands for analgesics and spread of cutaneous sensory blockade
after different concentration and volume of local anesthetics used for quadratus lumborum block.
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
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are going to prospectivily observe the analgesic effect and the dermatomal spread after quadratus lumborum block.
Management information
Registered date
| 2018 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035297
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
