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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Gynecologic disease | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |