UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of bilateral continuous transversus abdominis plane blocks for postoperative analgesia after gynecological cancer surgery: a prospective, randomized, placebo-controlled, triple-blind study
Title of the study (Brief title)	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	Hiroshi Baba
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
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	Takayuki Yoshida
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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