UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008081 |
|---|---|
| Receipt number | R000009516 |
| Scientific Title | Efficacy of wound catheter infusion for postoperative analgesia after single incision laparoscopic cholecystectomy: a randomized controlled trial |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2014/03/24 16:13:44 |
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Basic information
Public title
Efficacy of wound catheter infusion for postoperative analgesia after single incision laparoscopic cholecystectomy: a randomized controlled trial
Acronym
Evaluation of wound catheter infusion for postoperative analgesia after single incision laparoscopic cholecystectomy
Scientific Title
Efficacy of wound catheter infusion for postoperative analgesia after single incision laparoscopic cholecystectomy: a randomized controlled trial
Scientific Title:Acronym
Evaluation of wound catheter infusion for postoperative analgesia after single incision laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
Patients undergoing single incision laparoscopic cholecystectomy
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postoperative pain relief with wound catheter infusion after single incision laparoscopic cholecystectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative visual analog pain score (VAS)
Key secondary outcomes
Fentanyl consumption in PCA
Adverse effect
Length of the hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous fentanyl PCA with wound catheter infusion of 0.5% levobupivacaine
Interventions/Control_2
Intravenous fentanyl PCA with wound catheter infusion of normal saline
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Over 20 years old
2)Patients undergoing single incision laparoscopic cholecystectomy
3)ASA-PS 1-2
4)Obtained written informed consent
Key exclusion criteria
1)Patients having neurological disease, psychological disease, chronic pain that can affect the assessment of the outcomes
2)Patients having following clinically significant features; allergy to anesthetics, BMI is 30 or more, peripheral vascular impairment, respiratory disorder, immune deficiency disease, autoimmune disease, etc.3)Cases of conversion to open-surgery
4)Patients with perioperative biliary leakage
5)Patients undergoing simultaneous operation(s) other than cholecystectomy
6)Patients unable to use PCA
7)Cases of emergency operation
8)Patients with acute cholecystitis or pancreatitis
9)Patients indwelt with a drainage tube(s)
10)Patients are inadequate for this study judged by investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichiro ono |
Organization
KKR Takamatsu Hospital
Division name
Anesthesiology
Zip code
Address
4-18 tenjinmae takamatu-shi
TEL
087-861-3261
ono@kkr-ta-hp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Ono |
Organization
KKR Takamatsu Hospital
Division name
Department of Anesthesiology
Zip code
Address
4-18 tenjinmae takamatu-shi
TEL
087-861-3261
Homepage URL
rin-ken@kkr-ta-hp.gr.jp
Sponsor or person
Institute
KKR Takamatsu Hospital
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
| 2012 | Year | 06 | 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
| 2012 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2014 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009516
| 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 |
