Unique ID issued by UMIN | UMIN000013449 |
---|---|
Receipt number | R000015690 |
Scientific Title | Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery: a prospective, randomized, placebo-controlled, triple-blind study |
Date of disclosure of the study information | 2014/03/18 |
Last modified on | 2018/03/31 10:27:36 |
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery: a prospective, randomized, placebo-controlled, triple-blind study
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery: a prospective, randomized, placebo-controlled, triple-blind study
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery
Japan |
Patients scheduled for an elective gynecological cancer surgery including pelvic lymph node dissection or biopsy
Obstetrics and Gynecology | Anesthesiology |
Malignancy
NO
We will evaluate the efficacy of bilateral continuous transversus abdominis plane (TAP) blocks for postoperative analgesia after gynecological cancer surgery, compared with bilateral single-injection TAP blocks.
Safety,Efficacy
Confirmatory
Cumulative morphine consumption 24 h after the TAP catheter placement
Pain scale
Sedation level
Incidence of postoperative nausea and vomiting
Incidence of local anesthetic systemic toxicity
Time to ambulation
Time to flatus
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Medicine | Maneuver |
Patients will be inserted catheters into their bilateral transversus abdominis planes under ultrasound guidance and receive continuous infusions of local anesthetics through the catheters.
Patients will be inserted catheters into their bilateral transversus abdominis planes under ultrasound guidance and receive continuous infusions of normal saline through the catheters.
20 | years-old | <= |
80 | years-old | > |
Female
1. Patients undergoing gynecological cancer surgery including pelvic lymph node dissection or biopsy at Niigata University Medical and Dental Hospital
2. Written informed consent is provided
1. American Society of Anesthesiologists Physical Status 4 or above
2. Inability to communicate lucidly
3. Under 20 or over 80 years old
4. Body Mass Index >30 kg/m^2
5. Body weight <40 kg
6. Contraindication or allergy to drugs used in this study
7. Renal or hepatic failure
8. Pre-existing sensory disturbance of the trunk
9. Chronic opioid use
10. Previous laparotomy with the incision crossing the subcostal line
11. Infection at the injection site
12. Surgery without pelvic node dissection or biopsy
13. Patients who undergo colectomy including stoma creation
14. Pregnant woman
15. Patients who are regarded ineligible by researchers with any other reasons
80
1st name | |
Middle name | |
Last name | Hiroshi Baba |
Niigata University Graduate School of Medical and Dental Sciences
Division of Anesthesiology
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
025-227-2323
baba@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Takayuki Yoshida |
Niigata University Graduate School of Medical and Dental Sciences
Division of Anesthesiology
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
025-227-2328
ytaka@mac.com
Niigata University Medical and Dental Hospital
None
Self funding
NO
新潟大学医歯学総合病院(新潟県)
2014 | Year | 03 | Month | 18 | Day |
Published
Completed
2014 | Year | 02 | Month | 14 | Day |
2014 | Year | 03 | Month | 28 | Day |
2016 | Year | 02 | Month | 27 | Day |
2016 | Year | 02 | Month | 27 | Day |
2016 | Year | 02 | Month | 27 | Day |
2016 | Year | 03 | Month | 06 | Day |
2014 | Year | 03 | Month | 18 | Day |
2018 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015690