UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021038 |
|---|---|
| Receipt number | R000024277 |
| Scientific Title | Elderly patient outcomes associated with on-demand trunk blocks in the intensive care unit following emergency laparotomy |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2018/04/07 14:32:28 |
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Basic information
Public title
Elderly patient outcomes associated with on-demand trunk blocks in the intensive care unit following emergency laparotomy
Acronym
Trunk blocks may improve postoperative outcomes
Scientific Title
Elderly patient outcomes associated with on-demand trunk blocks in the intensive care unit following emergency laparotomy
Scientific Title:Acronym
Trunk blocks may improve postoperative outcomes
Region
| Japan |
Condition
Condition
emergency abdominal surgeries
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effect of on-demand trunk blocks (TAP block or RSB) at the bedside in ICU on early mobilization and postoperative outcomes of elderly patients who underwent emergency open abdominal surgery without epidural catheterization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elderly patients who were diagnosed with strangulated obstruction and who had undergone emergency colectomy were enrolled in this prospective, open-label trial. After emergency laparotomy, they were allocated to the Control or Block group; the Control group was treated with a fentanyl infusion for postoperative pain, whereas the Block group was treated with both trunk blocks and fentanyl infusion. The primary outcome was the time to walking.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Performing transversus abdominis plane block and rectus sheath block with the onset of somatic pain in the ICU.
Interventions/Control_2
Treat only with Fentanyl and Dexmedetomidine for postoperative analgesia in the ICU.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Critical-care patients in urgent abdominal surgery
Key exclusion criteria
unstable respiratory and hemodynamic status
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Hagihara |
Organization
Kagoshima medical association hospital
Division name
Anesthesiology
Zip code
Address
Kamoikeshinmachi 7-1, Kagoshima, Kagoshima
TEL
099-254-1125
hagihasg@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Hagihara |
Organization
Kagoshima medical association hospital
Division name
Anesthesiology
Zip code
Address
Kamoikeshinmachi 7-1, Kagoshima, Kagoshima
TEL
099-254-1125
Homepage URL
hagihasg@gmail.com
Sponsor or person
Institute
Kagoshima medical association 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
鹿児島市医師会病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | 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
The median (range) time to walking was significantly shorter in the Block group than in the Control group.
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2018 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024277
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/04/07 | Methods.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/04/07 | データ仕様書 Sheet1.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/04/07 | Dataset.pdf |
