UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000041455
Receipt No. R000047319
Scientific Title The effect of erector spinae plane block on postoperative analgesia after laparoscopic colorectal surgery
Date of disclosure of the study information 2022/08/18
Last modified on 2022/05/31

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Basic information
Public title The effect of erector spinae plane block on postoperative analgesia after laparoscopic colorectal surgery
Acronym effect of ESPB on postop. anlangesia after lap. colorectal surgery
Scientific Title The effect of erector spinae plane block on postoperative analgesia after laparoscopic colorectal surgery
Scientific Title:Acronym effect of ESPB on postop. anlangesia after lap. colorectal surgery
Region
Asia(except Japan)

Condition
Condition clinical trial
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing laparoscopic colorectal surgery under general anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total fentanyl consumption in the first 24 h
Key secondary outcomes VAS pain score (ranging from 0 indicating
no pain to 10 indicating extreme pain) at several postoperative time points, hospital stay duration, and any complications.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 ESPB
Interventions/Control_2 placebo
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
19 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria elective laparoscopic colorectal surgery under general anesthesia
Key exclusion criteria a local infection at the incision site
a history of hematological disorders including coagulation abnormality
severe hepatic impairment
chronic pain or a known allergy to the study drugs.
Target sample size 62

Research contact person
Name of lead principal investigator
1st name Seongjoo
Middle name
Last name Park
Organization Seoul national university Bundang hospital
Division name Anesthesiology and pain medicine
Zip code 13620
Address 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL +82317873642
Email struka@snubh.org

Public contact
Name of contact person
1st name Jin Hyoung
Middle name
Last name Park
Organization Seoul national university Bundang hospital
Division name Anesthesiology and pain medicine
Zip code 13620
Address 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL +82317873642
Homepage URL
Email quavadice@snubh.org

Sponsor
Institute self
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 Seoul national university Bundang hospital IRB
Address 172 Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel +82317878802
Email snubhirb@gmail.com

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
2022 Year 08 Month 18 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
2019 Year 10 Month 30 Day
Date of IRB
2019 Year 09 Month 10 Day
Anticipated trial start date
2020 Year 01 Month 16 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 18 Day
Last modified on
2022 Year 05 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047319

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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