UMIN-CTR Clinical Trial

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	Delay expected
Results Delay Reason	shortage of people
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	2020 Year 11 Month 16 Day

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