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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034396
Receipt No. R000039214
Scientific Title The analgesic effects of rectus sheath block compared to local anesthetic infiltration on laparoscopic percutaneous extraperitoneal closure in children.
Date of disclosure of the study information 2018/10/10
Last modified on 2018/12/09

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Basic information
Public title The analgesic effects of rectus sheath block compared to local anesthetic infiltration on laparoscopic percutaneous extraperitoneal closure in children.
Acronym The comparison between RSB and LAI on LPEC in children.
Scientific Title The analgesic effects of rectus sheath block compared to local anesthetic infiltration on laparoscopic percutaneous extraperitoneal closure in children.
Scientific Title:Acronym The comparison between RSB and LAI on LPEC in children.
Region
Japan

Condition
Condition Inguinal hernia
Classification by specialty
Surgery in general Pediatrics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the advantage of Rectal Sheath Block (RSB) for perioperative analgesia than Local Anesthetic Infiltration (LAI) on Laparoscopic Pericutaneous Extraperitoneal Closure (LPEC) in children (less than 16 years old).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scales at 4 hours after LPEC surgery
Key secondary outcomes "Intraoperative amount of Local anesthetic
Intraoperative amount of Remifentanil
Time to first dose of postoperative supplemental analgesia
Pain scale the next day after surgery"

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 "Both syringe A for RSB and syringe B for LAI are prepared for postoperative analgesia In all cases divided into the following two groups.

RSB group
Syring A=0.25% levobupivacaine
Syring B=Normal saline
0.25% syringe A 0.5 ml/kg (bilateral total) was administered as RSB before surgery. At the time of peritoneal closure, ask the surgeon to administrate syringe B (up to 0.5 ml/kg) into the umbilical surgical wound (on the peritoneal membrane) as LAI. Because the wound is small, the amount of syringe B is optional by the surgeon. Record the actual amount of syringe B after administration."
Interventions/Control_2 "Both syringe A for RSB and syringe B for LAI are prepared for postoperative analgesia In all cases devided into the following two groups.

LAI group
Syring A=Normal saline
Syring B=0.25% levobupivacaine
0.25% syringe A 0.5 ml/kg (bilateral total) was administered as RSB before surgery. At the time of peritoneal closure, ask the surgeon to administrate syringe B (up to 0.5 ml/kg) into the umbilical surgical wound (on the peritoneal membrane) as LAI. Because the wound is small, the amount of syringe B is optional by the surgeon. Record the actual amount of syringe B after administration."
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

Not applicable
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Children less than 16 years old scheduled LPEC except for the exclusion criteria shown below
Key exclusion criteria "1) Patients who should avoid administration of inhaled anesthetics (possible malignant hyperthermia or malignant syndrome)
2) Patients who should avoid administration of thiopental (history of severe asthma attacks)
3) Patients with ASA status 3 or higher
4) Patients taking analgesics within 12 hours before LPEC
5) Patients underwent other surgery within 24 hours before LPEC
6) Patients scheduled another surgery at the same time of LPEC
7) Patients with thrombocytopenia (50,000 /mcl or less) or taking anticoagulant
8) Patients who can not speak Japanese
9) Patients who are inappropriate to enroll this research by the researchers "
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuto Matsuoka
Organization Fukuyama Medical Center
Division name Anesthesiology
Zip code
Address 14-17, 4-chome, Okinogami-cho, Fukuyama City, Hiroshima, Japan
TEL 084-922-0001
Email me421078@s.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuto Matsuoka
Organization Fukuyama Medical Center
Division name Anesthesiology
Zip code
Address 14-17, 4-chome, Okinogami-cho, Fukuyama City, Hiroshima, Japan
TEL 084-922-0001
Homepage URL
Email me421078@s.okayama-u.ac.jp

Sponsor
Institute Independent Administrative Agency National Hospital Organization Fukuyama Medical Center (Clinical Research Department)
Institute
Department

Funding Source
Organization Independent Administrative Agency National Hospital Organization Fukuyama Medical Center (Clinical Research Department)
Organization
Division
Category of Funding Organization Government offices of other countries
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
2018 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 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
2018 Year 10 Month 05 Day
Last modified on
2018 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039214

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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