Unique ID issued by UMIN | UMIN000033979 |
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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 |
Effectiveness of continuous wound infusion of local anesthetic versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Effectiveness of continuous wound infusion of local anesthetics versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Effectiveness of continuous wound infusion of local anesthetic versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Effectiveness of continuous wound infusion of local anesthetics versus intravenous administration of fentanyl citrate after gynecologic surgery, randomized controlled trial
Japan |
Gynecologic disease
Surgery in general | Obstetrics and Gynecology | Anesthesiology |
Others
NO
compare effectiveness after gynecologic operation between continuous infiltration of local anesthetic and continuous intravenous opiate.
Efficacy
Visual analogue scale on 24 hour after surgery
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
interventions/ placement porous catheter infrafascia,and administer 0.25 % ropivacaine continuously during 48 hour
control/ administer fentanyl citrate 20 ug/hour transvenously during 48 hour
18 | years-old | <= |
80 | years-old | > |
Female
patients planned for elective midline laparotomy for gynecologic surgery
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
60
1st name | |
Middle name | |
Last name | Akira Kohyama |
tokyo metropolitan tama medical center
Obstetrics and Gynecology
2-8-29 Musashidai, Fuchu-shi, Tokyo
042-323-5111
nakamurahirotaka0114@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hirotaka Nakamura |
tokyo metropolitan tama medical center
Obstetrics and Gynecology
2-8-29 Musashidai, Fuchu-shi, Tokyo
042-323-5111
nakamurahirotaka0114@yahoo.co.jp
tokyo metropolitan tama medical center
office of metropolitan hospital management
Local Government
NO
2018 | Year | 09 | Month | 03 | Day |
Unpublished
Completed
2018 | Year | 08 | Month | 20 | Day |
2018 | Year | 08 | Month | 20 | Day |
2018 | Year | 08 | Month | 20 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 08 | Month | 31 | Day |
2022 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038724
Research Plan | |
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Registered date | File name |
2019/03/06 | 2018.7.20 介入研究実施計画書 最終.doc |
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Research case data | |
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