UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026931 |
|---|---|
| Receipt number | R000030894 |
| Scientific Title | Randomized double-blind controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2% |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2017/10/10 23:01:05 |
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Basic information
Public title
Randomized double-blind controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%
Acronym
Controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%
Scientific Title
Randomized double-blind controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%
Scientific Title:Acronym
Controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%
Region
| Japan |
Condition
Condition
postoperative pain
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy and safety between lebobupivacaine 0.125% and ropivacaine 0.2% in patient-controlled epidural analgesia after gynecological abdominal surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative dose of the 48hour local anesthetic obtained from the mechanical PCA pump
Key secondary outcomes
1.VAS at rest
2.VAS at move
3.use of analgesics
4.PCA push and administration
5.blood pressure lowering
6.moter blockade
7.ambulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PCEA using levobupivacaine 0.125%
Interventions/Control_2
PCEA using ropivacaine 0.2%
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
1.Elective gynecological abdminal surgery
2.Combination of general anesthesia and epidural anesthesia
3.Age over 20years
4.ASA physical status classification 1 or 2
Key exclusion criteria
1.Malignant tumor surgery
2.Cesarean section
3.Allergy of the amide-type local anesthetic
4.Contraindication of the epidural anaesthesia
5.History of the neurologic disease
6.Treatment of choronic pain
7.Poorly understand usage of PCEA
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hasegawa |
Organization
Toho University Omori Medical Center
Division name
Department of pharmacy
Zip code
Address
6-11-1,Omorinishi,Ota-ku,Tokyo
TEL
03-3762-4151
thasegawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hasegawa |
Organization
Toho University Omori Medical Center
Division name
Department of pharmacy
Zip code
Address
6-11-1,Omorinishi,Ota-ku,Tokyo
TEL
03-3762-4151
Homepage URL
thasegawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho 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
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
| 2017 | Year | 04 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 13 | 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
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030894
