UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery: a prospective, randomized, placebo-controlled, triple-blind study
Acronym
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery
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
Scientific Title:Acronym
Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery
Region
| Japan |
Condition
Condition
Patients scheduled for an elective gynecological cancer surgery including pelvic lymph node dissection or biopsy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative morphine consumption 24 h after the TAP catheter placement
Key secondary outcomes
Pain scale
Sedation level
Incidence of postoperative nausea and vomiting
Incidence of local anesthetic systemic toxicity
Time to ambulation
Time to flatus
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Patients will be inserted catheters into their bilateral transversus abdominis planes under ultrasound guidance and receive continuous infusions of local anesthetics through the catheters.
Interventions/Control_2
Patients will be inserted catheters into their bilateral transversus abdominis planes under ultrasound guidance and receive continuous infusions of normal saline through the catheters.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Baba |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2323
baba@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
Homepage URL
ytaka@mac.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015690
