UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013115 |
|---|---|
| Receipt number | R000015224 |
| Scientific Title | Comparison of the plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane block and rectus sheath block. |
| Date of disclosure of the study information | 2014/02/12 |
| Last modified on | 2017/02/16 21:33:35 |
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Basic information
Public title
Comparison of the plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane block and rectus sheath block.
Acronym
Comparison of the plasma levobupivacaine concentrations after ultrasound-guided peripheral nerve block.
Scientific Title
Comparison of the plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane block and rectus sheath block.
Scientific Title:Acronym
Comparison of the plasma levobupivacaine concentrations after ultrasound-guided peripheral nerve block.
Region
| Japan |
Condition
Condition
laparoscopic surgery
Classification by specialty
| Surgery in general | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane block and after rectus sheath block.
This study will reveal the time course of the levobupivacaine concentration, and further either is more effective and safe.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time course of the levobupivacaine concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We perform the Transversus Abdominis Plane block and measure plasma concentration of levobupivacaine.
Interventions/Control_2
We perform the Rectus Sheath block and measure plasma concentration of levobupivacaine.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose American Society of Anesthesiologists Physica Status are 1 - 3, planned to laparoscopic surgery and agree to Transversus Abdominis Plane block or Rectus Sheath block for postoperative analgesia are enrolled in this study.
Key exclusion criteria
Exclude criteria are the patients who have liver dysfunction (child-Pugh Score>B) or renal dysfunction (eGFR<60), history of local anesthetic allergy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Yasumura |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
ryasumur@ntmc.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Yasumura |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
ryasumur@ntmc.hosp.go.jp
Sponsor or person
Institute
National hospital organization Tokyo medical center
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015224
