UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026931
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email thasegawa@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.