UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020912
Receipt No. R000024128
Scientific Title Prospective randomized observer-blinded study comparing the analgesic efficacy of ultrasound-guided rectus sheath block to local anesthetic infiltration for laparoscopic percutaneous extraperitoneal closure
Date of disclosure of the study information 2016/04/01
Last modified on 2016/02/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective randomized observer-blinded study comparing the analgesic efficacy of ultrasound-guided rectus sheath block to local anesthetic infiltration for laparoscopic percutaneous extraperitoneal closure
Acronym The efficacy of US-guided rectus sheath block for laparoscopic percutaneous extraperitoneal closure
Scientific Title Prospective randomized observer-blinded study comparing the analgesic efficacy of ultrasound-guided rectus sheath block to local anesthetic infiltration for laparoscopic percutaneous extraperitoneal closure
Scientific Title:Acronym The efficacy of US-guided rectus sheath block for laparoscopic percutaneous extraperitoneal closure
Region
Japan

Condition
Condition laparoscopic inguinal hernia surgery of children performed under general anesthesia
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Day surgery forms a large and increasing part of pediatric surgical practice and controlling postoperative pain become more important. Local anesthetic infiltration is widely used methods to alleviate postoperative pain because of its simplicity. However, ultrasound guided peripheral nerve block would be alternative way because of its efficacy and certainty. Previous studies revealed that ultrasound guided rectus sheath block provide more effective postoperative pain relief for umbilical hernia than local anesthetic infiltration. There are no studies which compare the effect of ultrasound guided rectus sheath block to local anesthetic infiltration undergoing laparoscopic surgery for children. The objective of this study was to assess efficacy of rectus sheath block compare to that of local anesthetic infiltration for children undergoing laparoscopic percutaneous extraperitoneal closure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analgesic effect of rectus sheath block until 1 hour after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 use the local anesthetic infiltration
Interventions/Control_2 use the rectus sheath block
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
0 years-old <=
Age-upper limit
9 years-old >=
Gender Male and Female
Key inclusion criteria general anesthesia
inguinal hernia
laparoscopic surgery
Key exclusion criteria ASA 3 or grater
psychiatric illness
use of analgesics
allergy to ropivacaine
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Uchinami
Organization Tenshi hospital
Division name anesthesiology
Zip code
Address 1-1 North12East3 Higashiku Sapporo Hokkaido
TEL 011-711-0101
Email yukauma923@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumika Sakuraya
Organization tenshi hospital
Division name Anesthesiology
Zip code
Address 1-1 North12East3 Higashiku Sapporo Hokkaido
TEL 011-711-0101
Homepage URL
Email suemomoca@yahoo.co.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization none
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
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
2016 Year 04 Month 01 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 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
2016 Year 02 Month 06 Day
Last modified on
2016 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.