UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018239 |
|---|---|
| Receipt number | R000021114 |
| Scientific Title | Effects of ultrasound-guided transversus abdominis plane block and rectus sheath block on stress hormone response after laparoscopic colon surgery |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2022/07/12 10:59:42 |
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Basic information
Public title
Effects of ultrasound-guided transversus abdominis plane block and rectus sheath block on stress hormone response after laparoscopic colon surgery
Acronym
Effects of ultrasound-guided peripheral nerve block on laparoscopic colon surgery
Scientific Title
Effects of ultrasound-guided transversus abdominis plane block and rectus sheath block on stress hormone response after laparoscopic colon surgery
Scientific Title:Acronym
Effects of ultrasound-guided peripheral nerve block on laparoscopic colon surgery
Region
| Japan |
Condition
Condition
colon tumor
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effect of ultrasound-guided transversus abdominis plane block and rectus sheath block on perioperative stress hormone response after laparoscopic colon surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Plasma epinephrine concentration on the morning of postoperative day 1 (POD1).
Key secondary outcomes
Visual Analog Scale pain score, occurrence of drowsiness, concentration of plasma norepinephrine, cortisol and IL-6, and additional analgesics usage on the morning of POD1.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Ultrasound-guided transversus abdominis plane block and rectus sheath block with levobupivacaine.
Interventions/Control_2
No ultrasound-guided block.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled for laparoscopic colectomy in Iwate Medical University Hospital with written informed consent agreement.
Key exclusion criteria
Contraindication for any drugs used during anesthesia, chronic pain under treatment, nerve disorder and psychiatric diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Wakimoto |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Anesthesiology
Zip code
0208505
Address
19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
TEL
019-651-5111
silkhat_mw@hotmail.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Wakimoto |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Anesthesiology
Zip code
020-8505
Address
19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
TEL
019-651-5111
Homepage URL
silkhat_mw@hotmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, School of Medicine, Iwate Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine, Iwate Medical University
Address
19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
Tel
019-651-5111
imuctc@iwate-med.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
| 2015 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021114
| Research Plan | |
|---|---|
| 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 |
