Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000948291
Ethics application status
Approved
Date submitted
29/10/2009
Date registered
4/11/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized clinical trial of the influence of intraperitoneal local anesthesia on pain after laparoscopic colectomy
Scientific title
Randomized clinical trial of the influence of intraperitoneal local anesthesia on pain after laparoscopic colectomy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the patients undergoing laparoscopic colectomy 252067 0
Condition category
Condition code
Anaesthesiology 252268 252268 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three groups in total: Group I(infiltration), Group D(Double0, Group C(
Control).
Group I(Infiltration) : infiltration ropivacaine only at the beginning of the surgery
Group D(Double) : infiltration ropivacaine twice during the surgery (time of start and end of surgery)
Immediately after creation of pneumoperitoneum and place of the first two trocars 1 mg/kg of ropivacaine in 100 ml normal saline in Group I and Group D will be sprayed on the upper surface of right and left lobe of liver and left hemidiaphragm.
At the end of the operation and before withdrawing the first trocar, 100ml normal saline in Group I and 1 mg/kg of ropivacaine in 100 ml normal saline in Group D will be sprayed on the upper surface of right and left lobe of liver and left hemidiaphragm in Group D.
This is one off treatment.
Intervention code [1] 241462 0
Treatment: Drugs
Comparator / control treatment
Group C(Control) : control group without ropivacaine infiltration , only normal saline 100 ml
Immediately after creation of pneumoperitoneum and place of the first two trocars and at the end of the operation and before withdrawing the first trocar, 100 ml normal saline will be sprayed on the upper surface of right and left lobe of liver and left hemidiaphragm in Group C.
Control group
Placebo

Outcomes
Primary outcome [1] 253141 0
Patients will be assessed for pain using a visual analogue pain scale (VAS)
A VAS is a measurement instrument that tried to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
Timepoint [1] 253141 0
at six time intervals after surgery ; 2 h, 4 h, 8 h, 12 h, 24 h , and 48 h
Secondary outcome [1] 262034 0
The opioid consumption of the patients controlled analgesia (PCA) and additional opioid will be assessed
Timepoint [1] 262034 0
at six time intervals after surgery ; 2 h, 4 h, 8 h, 12 h, 24 h , and 48 h
Secondary outcome [2] 262035 0
PCM (patient controlled module :Number of attempt patient try to receive analgesics using PCA machine) of the PCA machine will be assessed
Timepoint [2] 262035 0
at six time intervals after surgery ; 2 h, 4 h, 8 h, 12 h, 24 h , and 48 h
Secondary outcome [3] 262036 0
nausea and vomiting
Timepoint [3] 262036 0
anytime after surgery when patient complaint

Eligibility
Key inclusion criteria
Patients will be scheduled to undergo elective laparoscopic colectomy.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients weigh under 45 kg or over 100 kg,
have severe underlying cardiovascular, renal, hepatic diseases, and have allergy to local anesthetics will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
choose the opaque envelope maintain computer-generated code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of three groups will be based using randomized number using excel program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2298 0
Korea, Republic Of
State/province [1] 2298 0

Funding & Sponsors
Funding source category [1] 243932 0
University
Name [1] 243932 0
Chuna-Ang University
Country [1] 243932 0
Korea, Republic Of
Primary sponsor type
University
Name
Chuna-Ang University
Address
221 Heukseok-Dong, Dongjak-Gu,

Seoul 156-755
Country
Korea, Republic Of
Secondary sponsor category [1] 251297 0
Hospital
Name [1] 251297 0
Chuna-Ang University Hospital
Address [1] 251297 0
224-1 Heukseok-Dong, Dongjak-Gu,

Seoul 156-755
Country [1] 251297 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244045 0
Ethics committee address [1] 244045 0
Ethics committee country [1] 244045 0
Date submitted for ethics approval [1] 244045 0
27/10/2009
Approval date [1] 244045 0
Ethics approval number [1] 244045 0

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

Contacts
Principal investigator
Name 30424 0
Address 30424 0
Country 30424 0
Phone 30424 0
Fax 30424 0
Email 30424 0
Contact person for public queries
Name 13671 0
Hyun Kang
Address 13671 0
224-1 Heukseok-Dong, Dongjak-Gu,

Seoul 156-755
Country 13671 0
Korea, Republic Of
Phone 13671 0
+82-2-6299-2571
Fax 13671 0
+82-2-6299-2575
Email 13671 0
[email protected]
Contact person for scientific queries
Name 4599 0
Hyun Kang
Address 4599 0
224-1 Heukseok-Dong, Dongjak-Gu,

Seoul 156-755
Country 4599 0
Korea, Republic Of
Phone 4599 0
+82-2-6299-2571
Fax 4599 0
+82-2-6299-2575
Email 4599 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.