Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000545864
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
22/05/2012
Date last updated
25/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intravenous lidocaine infusion on the pain after subtotal gastrectomy
Scientific title
In patients undergoing subtotal gastrectomy, is intravenous lidocaine infusion effective in reducing post-operative pain?
Secondary ID [1] 280535 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain following subtotal gastrectomy 286531 0
Condition category
Condition code
Anaesthesiology 286796 286796 0 0
Anaesthetics
Oral and Gastrointestinal 286797 286797 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] 284910 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] 287169 0
Pain score assessed using 100 point-visual analogue scale
Timepoint [1] 287169 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively
Secondary outcome [1] 297547 0
Frequency to push the button of patient controlled analgesia machine recorded by computerized patient controlled analgesia machine
Timepoint [1] 297547 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively
Secondary outcome [2] 297548 0
fentanyl consumption recorded by nurse
Timepoint [2] 297548 0
at 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively

Eligibility
Key inclusion criteria
patients undergoing subtotal gastrectomy
Minimum age
20 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
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] 4328 0
Korea, Republic Of
State/province [1] 4328 0

Funding & Sponsors
Funding source category [1] 285296 0
University
Name [1] 285296 0
Chung-Ang University
Country [1] 285296 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] 284156 0
None
Name [1] 284156 0
Address [1] 284156 0
Country [1] 284156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287306 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 287306 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 287306 0
Korea, Republic Of
Date submitted for ethics approval [1] 287306 0
Approval date [1] 287306 0
Ethics approval number [1] 287306 0
C2010074(369)

Summary
Brief summary
Intravenous lidocaine infusion in various type of surgery is known to effective in reducing post-operative pain, analgesic requirements, the stress response and lengthens the period to first post-operative analgesic requirement. We hypothesized that intravenous lidocaine infusion reduce the pain after subtotal gastrectomy. Therefore we performed a study to investigate the effectiveness of lidocaine on pain after subtotal gastrectomy .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34213 0
Address 34213 0
Country 34213 0
Phone 34213 0
Fax 34213 0
Email 34213 0
Contact person for public queries
Name 17460 0
Hyun Kang
Address 17460 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 17460 0
Korea, Republic Of
Phone 17460 0
+82-2-6299-2571, 2579, 2586
Fax 17460 0
+82-2-6299-2585
Email 17460 0
[email protected]
Contact person for scientific queries
Name 8388 0
Hyun Kang
Address 8388 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 8388 0
Korea, Republic Of
Phone 8388 0
+82-2-6299-2571, 2579, 2586
Fax 8388 0
+82-2-6299-2585
Email 8388 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
Dimensions AIIntraoperative systemic lidocaine for pre-emptive analgesics in subtotal gastrectomy: a prospective, randomized, double-blind, placebo-controlled study2014https://doi.org/10.1503/cjs.009613
N.B. These documents automatically identified may not have been verified by the study sponsor.