UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033056 |
|---|---|
| Receipt number | R000037690 |
| Scientific Title | Consideration of the validity of Erector Spinae Plane Block to trunk surgery |
| Date of disclosure of the study information | 2018/06/19 |
| Last modified on | 2020/08/17 13:55:15 |
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Basic information
Public title
Consideration of the validity of Erector Spinae Plane Block to trunk surgery
Acronym
Consideration of the validity of ESPB to trunk surgery
Scientific Title
Consideration of the validity of Erector Spinae Plane Block to trunk surgery
Scientific Title:Acronym
Consideration of the validity of ESPB to trunk surgery
Region
| Japan |
Condition
Condition
breast surgery / spine surgery / laparoscopic colon resection
Classification by specialty
| Gastrointestinal surgery | Breast surgery | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
do ESPB where it seems effective to breast cancer, spine surgery and colon cancer, and estimate their validity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS to a post-operatively for 48 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Erector Spinae Plane Block is performed before the surgery.
Interventions/Control_2
A usual analgesia is performed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The breast surgery, spine surgery and colon cancer operation under the laparoscope performed at my hospital in the period.
Key exclusion criteria
(1) Patient of a breast cancer operation of both sides
(2) Patient of a vertebrae cervicales operation
(3) Patient with a pathological change which doesn't suit that a tap has skin in the tap part
(4) Patient with the past allergic to local anesthetics
(5) The emergency operation patient who can think operation of a hand skill is dangerous
(6) Additionally the patient who judged that a study person in charge was unsuitable as a subject
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | masateru |
| Middle name | |
| Last name | kumemura |
Organization
Juntendo University Shizuoka Hospital
Division name
Anesthesiology
Zip code
4102295
Address
1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
TEL
055-948-3111
m-kumemura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | masateru |
| Middle name | |
| Last name | kumemura |
Organization
Juntendo University Shizuoka Hospital
Division name
Anesthesiology
Zip code
4102295
Address
1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
TEL
055-948-3111
Homepage URL
m-kumemura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Shizuoka Hospital
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
Juntendo University Shizuoka Hospital
Address
1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
Tel
055-948-3111
m-kumemura@juntendo.ac.jp
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
| 2018 | Year | 06 | Month | 19 | 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
114
Results
The 48-h NRS score was significantly lower in the ESPB group than in the non-ESPB group.
Results date posted
| 2020 | Year | 05 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because it is being submitted to an academic journal
Date of the first journal publication of results
Baseline Characteristics
The subjects were patients aged over 20 years old who underwent laparoscopic colorectal cancer surgery, breast cancer surgery, or spinal (thoracic vertebrae and lumbar spine) surgery under general anesthesia in the operating theater of our hospital between June 20, 2018 and February 7, 2019.
Participant flow
During the study period, 122 subjects met the inclusion criteria, and 114 subjects were randomized, resulting in 55 being assigned to the ESPB group and 59 to the non-ESPB group. In the ESPB group, 54 subjects, excluding one who discontinued due to procedural difficulty, underwent ESPB. Of them, three subjects were lost to follow-up (early discharge from the hospital in one case and unable to obtain NRS data in two cases), and the remaining 51 subjects were analyzed. All 59 subjects in the non-ESPB group were analyzed.
Adverse events
Regarding adverse reactions defined as secondary outcomes, one patient each in both groups complained of nausea, but there were no complaints of numbness of extremities or of itching.
Outcome measures
The primary outcome was the NRS scores at rest and on movement measured immediately and at 3, 6, 12, 24, and 48 h post-surgery. The presence or absence of nausea or vomiting, itching, and numbness of limbs were recorded as secondary outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 24 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 24 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037690
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/02 | ①研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/05/02 | espb_datasets_corrected.csv |
