UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized double-blind controlled trial of patient-controlled epidural analgesia after gynecological abdominal surgery with levobupivacaine 0.125% or ropivacaine 0.2%
Title of the study (Brief title)	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	Tetsuya Hasegawa
Organization	Toho University Omori Medical Center
Division name	Department of pharmacy
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	Tetsuya Hasegawa
Organization	Toho University Omori Medical Center
Division name	Department of pharmacy
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030894