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Recruitment status Completed
Unique ID issued by UMIN UMIN000008081
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email rin-ken@kkr-ta-hp.gr.jp

Sponsor
Institute KKR Takamatsu Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009516


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