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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024318
Receipt No. 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

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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
Email 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
Email Midoriko@gmail.com

Sponsor
Institute Fukuoka University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027996

Research Plan
Registered date File name
2019/04/09 臨床研究実施計画書 LPECrev4.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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