UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034396 |
|---|---|
| Receipt number | 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 | 2020/09/30 08:31:52 |
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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 | Yuto |
| Middle name | |
| Last name | Matsuoka |
Organization
Fukuyama Medical Center
Division name
Anesthesiology
Zip code
7208520
Address
14-17, 4-chome, Okinogami-cho, Fukuyama City, Hiroshima, Japan
TEL
084-922-0001
me421078@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuoka |
Organization
Fukuyama Medical Center
Division name
Anesthesiology
Zip code
7208520
Address
14-17, 4-chome, Okinogami-cho, Fukuyama City, Hiroshima, Japan
TEL
084-922-0001
Homepage URL
me421078@s.okayama-u.ac.jp
Sponsor or person
Institute
Independent Administrative Agency National Hospital Organization Fukuyama Medical Center (Clinical Research Department)
Institute
Department
Personal name
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
Independent Administrative Agency National Hospital Organization Fukuyama Medical Center (Clinical Research Department)
Address
14-17, 4-chome, Okinogami-cho, Fukuyama City, Hiroshima, Japan
Tel
084-922-0001
507-rinnsyou@mail.hosp.go.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
| 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
56
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039214
