UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038260 |
|---|---|
| Receipt number | 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 | 2020/11/16 16:46:12 |
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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 | Obstetrics 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
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
marubuchi222@yahoo.co.jp
Sponsor or person
Institute
Social medical corporation Miyazakizenjinkai hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043600
