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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013449
Receipt No. 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

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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
Obsterics 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
Email 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
Email ytaka@mac.com

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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