Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000007831
Ethics application status
Approved
Date submitted
16/12/2011
Date registered
3/01/2012
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of intravenous lidocaine infusion on the pain after laparoscopic assisted distal gastrectomy
Scientific title
In patients undergoing laparoscopic assisted distal gastrectomy, is intravenous lidocaine infusion effective in reducing post-operative pain?
Secondary ID [1] 279625 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain following laparoscopic assisted distal gastrectomy 285419 0
Condition category
Condition code
Anaesthesiology 285602 285602 0 0
Pain management
Oral and Gastrointestinal 285603 285603 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous (IV) lidocaine infusion:group: IV administration of 1mg/ml lidocaine was performed 2 minute before orotracheal intubation. Patients in arm1 received an IV bolus injection of lidocaine (1.5 mg/kg) followed by a continuous IV infusion of lidocaine at 2 mg/kg/hr during the operation (150-180 min).
Intervention code [1] 283906 0
Treatment: Drugs
Comparator / control treatment
Control group: patients in control group received an intravenous bolus injection of normal saline (1.5 ml/kg) followed by a continuous IV infusion of saline at 2 ml/kg/hr during the operation (150-180 min).
Control group
Placebo

Outcomes
Primary outcome [1] 286167 0
Pain score assessed using 100 point-visual analogue scale
Timepoint [1] 286167 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively
Secondary outcome [1] 295294 0
Frequency to push the button of patient controlled analgesia machine recordedy computerized patient controlled analgesia machine
Timepoint [1] 295294 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively
Secondary outcome [2] 295295 0
fentanyl consumption recorded by nurse
Timepoint [2] 295295 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively

Eligibility
Key inclusion criteria
patients undergoin laparoscopic assisted distal gastrectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
body weight lower than 45 kg or greater than 100 kg, history of severe underlying cardiovascular, pulmonary, 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
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4025 0
Korea, Republic Of
State/province [1] 4025 0

Funding & Sponsors
Funding source category [1] 284400 0
University
Name [1] 284400 0
Chung-Ang University
Country [1] 284400 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] 283329 0
None
Name [1] 283329 0
Address [1] 283329 0
Country [1] 283329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286358 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 286358 0
Ethics committee country [1] 286358 0
Korea, Republic Of
Date submitted for ethics approval [1] 286358 0
02/02/2011
Approval date [1] 286358 0
15/02/2011
Ethics approval number [1] 286358 0
c2011217(667)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33548 0
Address 33548 0
Country 33548 0
Phone 33548 0
Fax 33548 0
Email 33548 0
Contact person for public queries
Name 16795 0
Hyun Kang
Address 16795 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 16795 0
Korea, Republic Of
Phone 16795 0
+82-2-6299-2571, 2579, 2586
Fax 16795 0
+82-2-6299-2585
Email 16795 0
[email protected]
Contact person for scientific queries
Name 7723 0
Hyun Kang
Address 7723 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 7723 0
Korea, Republic Of
Phone 7723 0
+82-2-6299-2571, 2579, 2586
Fax 7723 0
+82-2-6299-2585
Email 7723 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
No additional documents have been identified.