UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical comparison of analgesic efficacy of local anesthesia and ultrasound-guided nerve block after laparoscopic colorectal surgery A Prospective,Rondomized,Single-blind Study
Title of the study (Brief title)	A clinical comparison of analgesic efficacy of local anesthesia and ultrasound-guided nerve block after laparoscopic colorectal surgery A Prospective,Rondomized,Single-blind Study
Region	Japan

Condition
Condition	Colorectal tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate analgesic efficacy of local anesthesia and ultrasound-guided nerve block and investigate frequency of their complications after laparoscopic colorectal surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain score(Numeric Rating Score)at rest and at motion for 48hours after surgery
Key secondary outcomes	1 Frequency of additional analgesic drugs 2 The time of initial additional analgesic drugs 3 Frequency of PONV(Post Operative Nausea and Vomiting) 4 Total amount of opioid used intraoperatively 5 Total amount of opioid used postoperatively 6 Complications 7 Postoperative hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Local anesthesia for skin incision site (0.375% ropivacaine)
Interventions/Control_2	Ultrasound-guided nerve block(Rectus sheath block,transversus abdominis plane block) (0.25% ropivacaine)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Laparoscopic colorectal surgery ASA-PS 1,2or 3
Key exclusion criteria	1 Patients with disturbance of consciousness 2 Patients with serious heart,kidney, liver or lung dysfuncion 3 Patients with cognitive dysfunction 4 Pregnant 5 BMI over 35
Target sample size	40

Research contact person
Name of lead principal investigator	RIE OTSUKI
Organization	Southern TOHOKU General Hospital
Division name	Department of anesthesiology
Address	7-115 Yatsuyamada Koriyama-city Fukushima
TEL	024-934-5322
Email	rie.ootsuki0119@gmail.com

Public contact
Name of contact person	RIE OTSUKI
Organization	Southern TOHOKU General Hospital
Division name	Department of anesthesiology
Address	7-115 Yatsuyamada Koriyama-city Fukushima
TEL	024-934-5322
Homepage URL
Email	rie.ootsuki0119@gmail.com

Sponsor
Institute	Southern TOHOKU General 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	脳神経疾患研究所附属総合南東北病院

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 10 Month 13 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 08 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028975