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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013115
Receipt No. 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

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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 Obsterics 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
Email 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
Email ryasumur@ntmc.hosp.go.jp

Sponsor
Institute National hospital organization Tokyo medical center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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