UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	study of postoperative pain relief by infiltration analgesia using multihole catheter
Title of the study (Brief title)	study of postoperative pain relief by infiltration analgesia using multihole catheter
Region	Japan

Condition
Condition	Postoperative pain
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the clinical effect of continuous infiltration and regional analgesia compared with conventional technique on postoperative pain relief
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analogue pain scale Amount of supplemental anesthetics Side effects of anesthetics
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	continuous infiltration analgesia
Interventions/Control_2	transversus abdominis plane block
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Female
Key inclusion criteria	Gynecological laparotomy
Key exclusion criteria	severe systemic complication coagulopaphy contraindication of local anesthetics, opioids and NSAIDs
Target sample size	174

Research contact person
Name of lead principal investigator	Kunihisa Hotta
Organization	Jichi Medical University
Division name	Department of Anesthesiology
Address	Yakushiji 3311-1, Shimotsuke, Tochigi
TEL	0285-44-2111
Email	hottak@jichi.ac.jp

Public contact
Name of contact person	Kunihisa Hotta
Organization	Jichi Medical University
Division name	Department of Anesthesiology
Address	Yakushiji 3311-1, Shimotsuke, Tochigi
TEL	0285-44-2111
Homepage URL
Email	hottak@jichi.ac.jp

Sponsor
Institute	Jichi Medical University Department of Anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 11 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 04 Month 15 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 10 Day
Last modified on	2016 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000004892