Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001215910
Ethics application status
Approved
Date submitted
17/11/2011
Date registered
25/11/2011
Date last updated
25/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are the lidocaine jelly application to chest tubes effective in relieving the postoperative pain after cardiac surgery?
Scientific title
In patients undergoing cardiac surgery, are the lidocaine jelly application to chest tubes effective in terms of pain intensity and duration?
Secondary ID [1] 273400 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients undergoing cardiac surgery 279181 0
Condition category
Condition code
Anaesthesiology 279376 279376 0 0
Pain management
Surgery 279377 279377 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2% lidocaine jelly applied on whole length of the chest tubes just before insertion. It will take about 30 second.
As the objective of this studi is to measure the effectiveness of lidocaine jelly in relieving the postoperative pain after cardiac surgery, we apply the lidocaine jelly in the intervention group.
Intervention code [1] 283735 0
Treatment: Other
Comparator / control treatment
Normal saline applied on whole length of the chest tubes just before insertion
Control group
Placebo

Outcomes
Primary outcome [1] 285969 0
Pain score assessed using visual analogue scale
Timepoint [1] 285969 0
at extubation, 1 day, 3day, 7day postoperatively
Secondary outcome [1] 294866 0
Frequency to push the button of patient controlled analgesia machine recordedy computerized patient controlled analgesia machine
Timepoint [1] 294866 0
at extubation, 1 day, 3day, 7day postoperatively
Secondary outcome [2] 294867 0
fentanyl consumption recorded by nurse
Timepoint [2] 294867 0
at extubation, 1 day, 3day, 7day postoperatively

Eligibility
Key inclusion criteria
patients undergoing cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency surgery, perioperative intra aortic balloon pump, extracorporeal membrane oxygenator, reoperation for bleeding, additional postoperative drainage catheter insertion, postoperative cognitive dysfunction
history of severe underlying renal or hepatic disease, or allergy to local anaesthetics

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the two groups was based on Excel random-number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3954 0
Korea, Republic Of
State/province [1] 3954 0

Funding & Sponsors
Funding source category [1] 284217 0
University
Name [1] 284217 0
Chung-Ang University
Country [1] 284217 0
Korea, Republic Of
Primary sponsor type
University
Name
Chung-Ang University
Address
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country
Korea, Republic Of
Secondary sponsor category [1] 269177 0
Hospital
Name [1] 269177 0
Chung-Ang University Hospital
Address [1] 269177 0
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country [1] 269177 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286177 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 286177 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 286177 0
Korea, Republic Of
Date submitted for ethics approval [1] 286177 0
Approval date [1] 286177 0
05/06/2011
Ethics approval number [1] 286177 0
c2010049(344)

Summary
Brief summary
Pain management after cardiac surgery is very important.
Pain locations are at the sternum and drainage catheter insertion sites.This study was designed to analyze effect of lidocaine jelly application to chest tubes on pain intensity and duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33401 0
Address 33401 0
Country 33401 0
Phone 33401 0
Fax 33401 0
Email 33401 0
Contact person for public queries
Name 16648 0
Hyun Kang
Address 16648 0
Department of Anesthesiology and Pain Medicine
College of Medicine
Chung-Ang University
224-1 Heukseok-Dong, Dongjak-Gu,
Seoul 156-755, Republic of Korea
Country 16648 0
Korea, Republic Of
Phone 16648 0
+82-2-6299-2571
Fax 16648 0
+82-2-6299-2575
Email 16648 0
[email protected]
Contact person for scientific queries
Name 7576 0
Hyun Kang
Address 7576 0
Department of Anesthesiology and Pain Medicine
College of Medicine
Chung-Ang University
224-1 Heukseok-Dong, Dongjak-Gu,
Seoul 156-755, Republic of Korea
Country 7576 0
Korea, Republic Of
Phone 7576 0
+82-2-6299-2571
Fax 7576 0
+82-2-6299-2575
Email 7576 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseApplication of lidocaine jelly on chest tubes to reduce pain caused by drainage catheter after coronary artery bypass surgery.2014https://dx.doi.org/10.3346/jkms.2014.29.10.1398
N.B. These documents automatically identified may not have been verified by the study sponsor.