UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020912 |
|---|---|
| Receipt number | 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 20:12:21 |
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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
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
suemomoca@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
