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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033979
Receipt No. R000038724
Scientific Title Effectiveness of continuous wound infusion of local anesthetic versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Date of disclosure of the study information 2018/09/03
Last modified on 2019/09/02

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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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