UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022412 |
|---|---|
| Receipt number | R000019566 |
| Scientific Title | Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2018/06/05 15:19:20 |
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Basic information
Public title
Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery
Acronym
The efficacy of local anesthesia in laparoscopic surgery
Scientific Title
Prospective analysis of the efficacy of local anesthesia on post-surgical pain in laparoscopic surgery
Scientific Title:Acronym
The efficacy of local anesthesia in laparoscopic surgery
Region
| Japan |
Condition
Condition
Gynecological tumor
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of the effect of the post-operative pain control of local anesthesia in gynecological laparoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of postoperative analgesics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of local anesthesia into the wound
Interventions/Control_2
Injection of saline to the wound
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with laparoscopic surgery scheduled for gynecological benign disease and endometrial cancer
Key exclusion criteria
using the epidural anesthesia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Shimoya |
Organization
Kawasaki Medical School
Division name
Department of Obstetrics and Gynecology
Zip code
Address
577Mathusima Kurashiki city Okayama Prefecture
TEL
0864621111
gyne@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Sugihara |
Organization
Kawasaki Medical School
Division name
Department of Obstetrics and Gynecology
Zip code
Address
577Mathusima Kurashiki city Okayama Prefecture
TEL
0864621111
Homepage URL
gyne@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Address
Tel
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
| 2016 | Year | 05 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019566
