UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024318 |
|---|---|
| Receipt number | R000027996 |
| Scientific Title | Study of the spread of local anesthetic in the ultrasound-guided rectus sheath block |
| Date of disclosure of the study information | 2016/10/06 |
| Last modified on | 2019/04/16 23:19:39 |
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Basic information
Public title
Study of the spread of local anesthetic in the ultrasound-guided rectus sheath block
Acronym
Study of the spread of local anesthetic in the ultrasound-guided rectus sheath block
Scientific Title
Study of the spread of local anesthetic in the ultrasound-guided rectus sheath block
Scientific Title:Acronym
Study of the spread of local anesthetic in the ultrasound-guided rectus sheath block
Region
| Japan |
Condition
Condition
Inguinal hernia to perform pediatric laparoscopic perctaneous extraperitoneal closure
Classification by specialty
| Surgery in general | Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Under laparoscopic perctaneous extraperitoneal closure is a minimally invasive surgery, postoperative pain is strong, especially the umbilical region strongly than open surgery. We have performed the ultrasound guided rectus sheath block for the purpose of the pain relief for the same surgery from 2014. It revealed that there is an analgesic effect than the local infiltration anesthesia to the umbilicus.
However, there are cases analgesic effect is insufficient, potential spread of local anesthetic in the rectus abdominis muscle after sheath as the cause is not enough has been considered. Since few reports on the relationship of the distribution range and the analgesic effect of a local anesthetic, reveal this.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect of the rectus sheath block from anesthesia end until after 8 hours
Key secondary outcomes
Distribution range of local anesthetic in the ultrasound image
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 2 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients undergoing laparoscopic perctaneous extraperitoneal closure against inguinal hernia
Key exclusion criteria
ASA3 or more, re-surgery, patients who are using the analgesics from preoperatively, patients in the abdominal wall and the rectus abdominis muscle there is a lesion other than inguinal hernia, patients with a history of abdominal surgery, patients carry out the umbilical hernia surgery at the same time, surgery cases of adverse events associated with occurs
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Midoriko |
| Middle name | |
| Last name | Higashi |
Organization
Fukuoka University Hospital
Division name
Department of anesthesia
Zip code
8140180
Address
7-45-1,Nanakuma,Jyonan-ku,Fukuoka city,Fukuoka,Japan
TEL
092-801-1011
midoriko@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Midoriko |
| Middle name | |
| Last name | Higashi |
Organization
Fukuoka University Hospital
Division name
Department of anesthesia
Zip code
8140180
Address
7-45-1,Nanakuma,Jyonan-ku,Fukuoka city,Fukuoka,Japan
TEL
092-801-1011
Homepage URL
Midoriko@gmail.com
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Fukuoka University Hospital
Address
7-45-1,Nanakuma,Jyonan-ku,Fukuoka city,Fukuoka,Japan
Tel
092-801-1011
hayakawaka@adm.fukuoka-u.ac.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
| 2016 | Year | 10 | Month | 06 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment of pain from anesthesia end until after 8 hours
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027996
