UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041455 |
|---|---|
| Receipt number | 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 | 2022/11/18 08:47:24 |
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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
Double blind -all involved 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
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
quavadice@snubh.org
Sponsor or person
Institute
self
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
Seoul national university Bundang hospital IRB
Address
172 Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel
+82317878802
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 | 11 | Month | 18 | Day |
Link to view the page
Value
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 |
