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Trial registered on ANZCTR


Registration number
ACTRN12610000649011
Ethics application status
Approved
Date submitted
9/08/2010
Date registered
10/08/2010
Date last updated
10/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of intravenous lidocaine infusion and intraperitoneal lidocaine instillation on the pain after laparoscopic appendectomy
Scientific title
In patients undergoing laparoscopic appendectomy, is intravenous lidocaine infusion and intraperitoneal lidocaine instillation more effective than a placebo in reducing post-operative pain?
Secondary ID [1] 252399 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain following laparoscopic appendectomy 257911 0
Condition category
Condition code
Anaesthesiology 258077 258077 0 0
Pain management
Oral and Gastrointestinal 258084 258084 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
arm1:intravenous (IV) lidocaine infusion:
IV lidocaine administration 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 at 2 mg/kg/hr during the operation (60 minutes).
arm2.intraperitoneal lidocaine instillation:
Intraperitoneal instillation of lidocaine (total instillation dose 3.5 mg/kg) were administered immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery.
Intervention code [1] 256968 0
Treatment: Drugs
Comparator / control treatment
One control group received an intravenous bolus injection of normal saline (1.5 ml/kg) followed by a continuous IV infusion at 2 ml/kg/hr during the operation (60 minutes) and received intraperitoneal normal saline instillation (100ml) immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 258937 0
Pain score assessed using visual analogue scale
Timepoint [1] 258937 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Secondary outcome [1] 265108 0
Frequency to push the button of patient controlled analgesia machine recordedy computerized patient controlled analgesia machine
Timepoint [1] 265108 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Secondary outcome [2] 265109 0
fentanyl consumption recorded by nurse
Timepoint [2] 265109 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively

Eligibility
Key inclusion criteria
patients undergoin laparoscopic appendectomy
Minimum age
18 Years
Maximum age
65 Years
Gender
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 three 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2810 0
Korea, Republic Of
State/province [1] 2810 0

Funding & Sponsors
Funding source category [1] 257420 0
University
Name [1] 257420 0
Chung-Ang University
Address [1] 257420 0
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755
Country [1] 257420 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] 256654 0
None
Name [1] 256654 0
Address [1] 256654 0
Country [1] 256654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259443 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 259443 0
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Ethics committee country [1] 259443 0
Korea, Republic Of
Date submitted for ethics approval [1] 259443 0
09/01/2010
Approval date [1] 259443 0
08/02/2010
Ethics approval number [1] 259443 0
C2010007(302)

Summary
Brief summary
Intra-peritoneal instillation of local anaesthetics in laparoscopic procedures reduces post-operative pain, analgesic requirements, the stress response and lengthens the period to first post-operative analgesic requirement.
Another alternative approach to accelerate outcomes after operation is intravenous lidocaine.
We hypothesized that intravenous lidocaine infusion and intraperitoneal lidocaine instillation reduce the pain after laparoscopic surgery. Therefore we investigated a comparative study on multimodal lidocaine pre emptive analgesia in laparoscopic appendectomy patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31492 0
Address 31492 0
Country 31492 0
Phone 31492 0
Fax 31492 0
Email 31492 0
Contact person for public queries
Name 14739 0
Hyun Kang
Address 14739 0
Department of Anaesthesiology and Pain Medicine
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country 14739 0
Korea, Republic Of
Phone 14739 0
+82-2-6299-2571, 2579, 2586
Fax 14739 0
+82-2-6299-2585
Email 14739 0
roman00@naver.com
Contact person for scientific queries
Name 5667 0
Hyun Kang
Address 5667 0
Department of Anaesthesiology and Pain Medicine
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country 5667 0
Korea, Republic Of
Phone 5667 0
+82-2-6299-2571, 2579, 2586
Fax 5667 0
+82-2-6299-2585
Email 5667 0
roman00@naver.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary