UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025188 |
|---|---|
| Receipt number | 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 12:45:31 |
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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
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
rie.ootsuki0119@gmail.com
Sponsor or person
Institute
Southern TOHOKU General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028975
