UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane block and rectus sheath block.
Title of the study (Brief title)	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	Rie Yasumura
Organization	National hospital organization Tokyo medical center
Division name	Anesthesiology
Address	2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL	03-3411-0111
Email	ryasumur@ntmc.hosp.go.jp

Public contact
Name of contact person	Rie Yasumura
Organization	National hospital organization Tokyo medical center
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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