Unique ID issued by UMIN | UMIN000014746 |
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Receipt number | R000016945 |
Scientific Title | Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial |
Date of disclosure of the study information | 2014/08/01 |
Last modified on | 2017/02/20 13:36:44 |
Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Efficiency and safety of laparoscopic reutus shaeth block
Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Efficiency and safety of laparoscopic reutus shaeth block
Japan |
Regional anesthesia in gynecologic laparoscopy
Surgery in general | Obstetrics and Gynecology |
Others
NO
Our aim is to evaluate the efficiency and the safety of laparoscopic regional anesthesia for abdominal wall in laparoscopy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Evaluating postoperative pain at 6 hour, 12hour and postoperative days1-3 by Wong-Baker pain scale .
Evaluating the number of postoperative analgesics.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine | Maneuver |
Patients randomly are assigned with a 1:1 ratio to receive injection or not. Control group have no regional anesthesia and prescribe oral medicine, suppository and intramuscular injection of analgesics.
Patients randomly are assigned with a 1:1 ratio to receive injection or not. Injection group are injected regional anesthetic onto peritoneum in laparoscopy under general anesthesia. This group can also receive analgesics.
20 | years-old | <= |
Not applicable |
Female
1)Patients scheduling to undergo benign gynecologic laparoscopy
2)Female patients older than 19 years
3)Patients who approve our research program and write informed consent
1)Patients weighing less than 50kg
2)Patients with severe disorder of liver function
3)Patients on chronic hemodialysis
4)Patients with clotting abnormality
5)Patients taking anticoagulant and antiplatelet
6)Patients with diabetes mellitus and multiple sclerosis
7)Patients with allergy for regional anesthetic
8)Patients scheduling to undergo single-incision laparoscopy
9)Patients with any difficulty in regional anesthesia
200
1st name | |
Middle name | |
Last name | Toru Hachisuga |
University of Occupational Environmental Health, Japan
Department of Obstetrics and Gynecology
1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
093-603-1611
thachisu@med.uoeh-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuyuki Kinjo |
University of Occupational Environmental Health, Japan
Department of Obstetrics and Gynecology
1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
093-603-1611
kinjo-yasuyuki@med.uoeh-u.ac.jp
Department of Obstetrics and Gynecology, University of Occupational Environmental Health, Japan
none
Self funding
NO
産業医科大学病院(福岡県)
2014 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 13 | Day |
2014 | Year | 08 | Month | 01 | Day |
2017 | Year | 02 | Month | 20 | Day |
2017 | Year | 02 | Month | 20 | Day |
2017 | Year | 02 | Month | 20 | Day |
2014 | Year | 08 | Month | 01 | Day |
2017 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016945
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