UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031275 |
|---|---|
| Receipt number | R000035708 |
| Scientific Title | Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2022/07/04 21:57:03 |
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Basic information
Public title
Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Acronym
Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Scientific Title
Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Scientific Title:Acronym
Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Region
| Japan |
Condition
Condition
Surgical patients who underwent video-assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate severity of postoperative pain and to determine the optimal method in analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from ICU admission to first administration of additional analgesic
Key secondary outcomes
Dose of opioids
Dose of NSAIDs
Use of epidural anesthesia
Use of local filtration anesthesia
Use of intercostal blockade
Pain severity (numeric rating scale)
Incidence of PONV
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Surgical patients who underwent video-assisted thoracic surgery
Key exclusion criteria
Liver dysfunction
Renal dysfunction
Communication disorder with psychiatric disease
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
sugino@ruby.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
Homepage URL
sugino@ruby.ocn.ne.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
0227178007
med-kenkyo@grp.tohoku.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Publication of results
Partially published
Result
URL related to results and publications
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Number of participants that the trial has enrolled
231
Results
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Results date posted
| 2022 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Participant flow
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Adverse events
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Outcome measures
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2018&index=18&absnum=4383
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
We will asign 350 patients to the trial.
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035708
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
