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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025188
Receipt No. R000028975
Scientific 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
Date of disclosure of the study information 2016/12/08
Last modified on 2018/06/12

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Basic information
Public 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
Acronym A clinical comparison of analgesic efficacy of local anesthesia and ultrasound-guided nerve block after laparoscopic colorectal surgery
A Prospective,Rondomized,Single-blind Study
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name RIE OTSUKI
Organization Southern TOHOKU General Hospital
Division name Department of anesthesiology
Zip code
Address 7-115 Yatsuyamada Koriyama-city Fukushima
TEL 024-934-5322
Email rie.ootsuki0119@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name RIE OTSUKI
Organization Southern TOHOKU General Hospital
Division name Department of anesthesiology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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
2016 Year 10 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028975

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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