UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008877 |
|---|---|
| Receipt number | R000010154 |
| Scientific Title | 1. The effect of the bilateral transversus abdominis plane block after laparoscopic cholecystectomy; posterior approach versus subcostal approach. A randomized clinical trial. |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2014/03/07 14:44:07 |
* 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
1. The effect of the bilateral transversus abdominis plane block after laparoscopic cholecystectomy; posterior approach versus subcostal approach. A randomized clinical trial.
Acronym
1. The effect of the bilateral transversus abdominis plane block after laparoscopic cholecystectomy; posterior approach versus subcostal approach. A randomized clinical trial.
Scientific Title
1. The effect of the bilateral transversus abdominis plane block after laparoscopic cholecystectomy; posterior approach versus subcostal approach. A randomized clinical trial.
Scientific Title:Acronym
1. The effect of the bilateral transversus abdominis plane block after laparoscopic cholecystectomy; posterior approach versus subcostal approach. A randomized clinical trial.
Region
| Japan |
Condition
Condition
Patients scheduled for elective laparoscopic cholecystectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test the hypothesis that the bilateral subcostal transversus abdominis plane block may decrease postoperative pain compared with posterior approach after laparoscopic cholecystectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Pain scores while coughing for the first 24 postoperative hours
Key secondary outcomes
Pain at rest for the first 24 postoperative hours
Intraoperative opioid consumption
Postoperative opioid consumption for the first 12 postoperative hours
Additional analgesics
The number of patients with postoperative nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ultrasound-guided posterior transversus abdominis plane block
Interventions/Control_2
ultrasound-guided subcostal transversus abdominis plane 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)American Society of Anaesthesiologists Physical Status 1-2
2)20-80yr old, male and female
3)Patients scheduled for elective laparoscopic cholecystectomy
4)Written informed consent is provided
Key exclusion criteria
1)Blood coagulation pathologies
2)Laparoscopic single site surgery
3)Open cholecystectomy
4)Emergency surgery
5)Infection at needle insertion site
6)Allergy to any of the drugs used in this study
7)Chronic opioid use
8)Inability to understand the study protocol
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayo Takimoto |
Organization
Ikeda City Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-18 Jyonan, Ikeda City, Osaka,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayo Takimoto |
Organization
Ikeda City Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-18 Jyonan, Ikeda City, Osaka,Japan
TEL
Homepage URL
kayota1219@yahoo.co.jp
Sponsor or person
Institute
Ikeda City Hospital
Institute
Department
Personal name
Funding Source
Organization
Ikeda City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2012 | Year | 09 | Month | 10 | 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
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 07 | Day |
Last modified on
| 2014 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010154
