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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038260
Receipt No. R000043600
Scientific Title Effectiveness of laparoscopic rectus sheath block compared with ultrasound-guide rectus sheath block
Date of disclosure of the study information 2019/10/10
Last modified on 2019/10/10

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Basic information
Public title Effectiveness of laparoscopic rectus sheath block compared with ultrasound-guide rectus sheath block
Acronym Examination of effectiveness of laparoscopic rectus sheath block
Scientific Title Effectiveness of laparoscopic rectus sheath block compared with ultrasound-guide rectus sheath block
Scientific Title:Acronym Examination of effectiveness of laparoscopic rectus sheath block
Region
Japan

Condition
Condition gallbladder stone, cholecystitis, inguinal hernia, benign ovarian tumor
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery Obsterics and gynecology
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the conventional rectus rectus sheath block with the laparoscopic rectus sheath block and examine its effectiveness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numerical Rating Scale(NRS), Prince Henry pain scale (PHS) after returning to the ward
Key secondary outcomes NRS and PHS after 1, 2, 6, 12, 24, 48 hours later, time to hope for analgesics, amount of analgesics used

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Randomly assign 15 patients undergoing laparoscopic cholecystectomy to the laparoscopic rectus sheath block group or the ultrasound-guided rectus sheath block group
Interventions/Control_2 Randomly assign 15 patients each to undergo laparoscopic inguinal hernia surgery to laparoscopic rectus abdominal sheath block group or ultrasound-guide rectus sheath block group
Interventions/Control_3 Randomly assign 15 patients undergoing laparoscopic benign ovarian tumor removal to the laparoscopic rectus sheath block group or the ultrasound-guide rectus sheath block group
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients whose American Society of Anesthesiologists Physica Status are 1 - 2, planned to laparoscopic surgery and agree to laparoscopic rectus sheath block or ultrasound-guided rectus sheath block for postoperative analgesia are enrolled in this study.
Key exclusion criteria Malignant tumor strongly suspected, pregnant woman, allergy to local anesthetics, severe liver / renal dysfunction
Dialysis, coagulopathy (patients who take antiplatelet drugs or anticoagulants during the perioperative period), presence of preoperative neuropathy, laparotomy (transition), epidural anesthesia
Patients taking analgesics (acetaminophen, loxoprofen, diclofenac, pentazocine, opioid), patients who cannot understand the contents of the research explanation document, alcoholism, wound infection, BMI> 30
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Marubuchi
Middle name
Last name Takahito
Organization Social medical corporation Miyazakizenjinkai hospital
Division name Anesthesiology
Zip code 8800834
Address Eguchi950-1, Shimbeppucho, Miyazaki City, Miyazaki prefecture, Japan
TEL 0985261599
Email marubuchi222@yahoo.co.jp

Public contact
Name of contact person
1st name Marubuchi
Middle name
Last name Takahito
Organization Social medical corporation Miyazakizenjinkai hospital
Division name Anesthesiology
Zip code 8800834
Address Eguchi950-1, Shimbeppucho, Miyazaki City, Miyazaki prefecture, Japan
TEL 0985261599
Homepage URL
Email marubuchi222@yahoo.co.jp

Sponsor
Institute Social medical corporation Miyazakizenjinkai hospital
Institute
Department

Funding Source
Organization Social medical corporation Miyazakizenjinkai hospital
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 Social medical corporation Miyazakizenjinkai hospital IRB
Address Eguchi950-1, Shimbeppucho, Miyazaki City, Miyazaki prefecture, Japan
Tel 0985261599
Email marubuchi222@yahoo.co.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
2019 Year 10 Month 10 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
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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 23 Day
Date of IRB
2019 Year 07 Month 23 Day
Anticipated trial start date
2019 Year 07 Month 24 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 10 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043600

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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