UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of continuous wound infusion of local anesthetic versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Acronym	Effectiveness of continuous wound infusion of local anesthetics versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Scientific Title	Effectiveness of continuous wound infusion of local anesthetic versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Scientific Title:Acronym	Effectiveness of continuous wound infusion of local anesthetics versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Region	Japan

Condition
Condition	Gynecologic disease
Classification by specialty	Surgery in general Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	compare effectiveness after gynecologic operation between continuous infiltration of local anesthetic and continuous intravenous opiate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analogue scale on 24 hour after surgery
Key secondary outcomes	frequency of adjuvant analgesics, time until require adjuvant analgesics after surgery, amount of consumption of fentanyl citrate, visual analogue scale on 48 hour after surgery, number of days until ambulation, frequency of vomiting or nausea, presence of vertigo or dizziness, frequency of local anesthetic intoxication, frequency of wound infection, other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	interventions/ placement porous catheter infrafascia,and administer 0.25 % ropivacaine continuously during 48 hour
Interventions/Control_2	control/ administer fentanyl citrate 20 ug/hour transvenously during 48 hour
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	patients planned for elective midline laparotomy for gynecologic surgery
Key exclusion criteria	1)can not use IV-PCA 2)history of postoperative pain management difficulty 3)emergency surgery 4)psychiatric disease 5)use opiate or NSAIDs routinely 6)ropivacaine or NSAIDs allergy 7)BMI>35kg/m2 8)systematic infection
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Kohyama
Organization	tokyo metropolitan tama medical center
Division name	Obstetrics and Gynecology
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL	042-323-5111
Email	nakamurahirotaka0114@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hirotaka Nakamura
Organization	tokyo metropolitan tama medical center
Division name	Obstetrics and Gynecology
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL	042-323-5111
Homepage URL
Email	nakamurahirotaka0114@yahoo.co.jp

Sponsor
Institute	tokyo metropolitan tama medical center
Institute
Department

Funding Source
Organization	office of metropolitan hospital management
Organization
Division
Category of Funding Organization	Local Government
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	2018 Year 09 Month 03 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	No longer recruiting
Date of protocol fixation	2018 Year 08 Month 20 Day
Date of IRB	2018 Year 08 Month 20 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 31 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038724

Research Plan
Registered date	File name
2019/03/06	2018.7.20 介入研究実施計画書　最終.doc

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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