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

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 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

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

Value
https://center6.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