UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033979 |
|---|---|
| Receipt number | 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 | 2022/03/07 16:33:24 |
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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 | Obstetrics 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
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
nakamurahirotaka0114@yahoo.co.jp
Sponsor or person
Institute
tokyo metropolitan tama medical center
Institute
Department
Personal name
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
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
Completed
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
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.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 |
