Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000745246
Ethics application status
Approved
Date submitted
26/08/2009
Date registered
27/08/2009
Date last updated
20/02/2019
Date data sharing statement initially provided
10/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised, Placebo Controlled Trial of Ropivocain Wound Infusion in Laparoscopic Colonic Resection
Scientific title
Do patients who undergo laparoscopic colonic resections who receive ropivocain wound infusions, compared to normal saline infusions have better postoperative pain relief with reduced requirements for opioids.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain relief following laparoscopic colorectal surgery 243593 0
Condition category
Condition code
Surgery 239876 239876 0 0
Surgical techniques
Anaesthesiology 239881 239881 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ropivocain (a form of local anaesthetic) infusion (10mL/hr) at the surgical incision site using fine bore catheter inserted at the time of wound closure. Infusion commences upon application of the wound dressings and continues until postoperative day 3. At this time the catheter is to be removed by nursing staff on the ward 72 hours after the infusion started.
Laparoscopic procedures are best known as keyhole procedures and involve using long instruments to manipulate the organs within the abdomen through very small incisions. Colonic resection refers to the removal of a part of the large bowel for a variety of indications although the most common indications are sepsis due to local perforation and malignancy.
Intervention code [1] 241181 0
Treatment: Drugs
Comparator / control treatment
normal saline infused at 10mL/hr at the surgical site from the time of dressing application using a fine bore catheter. Catheter is inserted at the time of wound closure and the infusion is continued for 72 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 240666 0
opioid requirements postoperatively
Timepoint [1] 240666 0
daily through out the postoperative period, until patient discharged from hospital
Primary outcome [2] 240667 0
visual analogue pain scale ratings of postoperative pain
Timepoint [2] 240667 0
daily through out the postoperative period until discharged from hospital
Secondary outcome [1] 257303 0
time to return to bowel function - flatus, bowel motion, tolerating fluids and normal diet
Timepoint [1] 257303 0
daily, until restoration of normal function

Eligibility
Key inclusion criteria
all patients booked for elective laparoscopic colonic resection over the age of 18 who are able to give informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal failure
chronic pain syndromes or already on long term analgesia, regardless of indication
urgent or emergency procedures

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 surgeon booking the patient for procedure (who will perform the surgery) will inform patient about the trial and seek their agreement to participate. The research assistant (who is unaware of the outcome of group allocation) also attends to discuss further any questions the patents have - subsequent phone contact (1 week later) is made with patient to see if they are interested in participating. Upon consent to participate contact made with research coordinator who will uses a computer-based random number generator to determine allocation to treatment or control. Only the surgeon performing the operation will be aware of the treatment the patient is receiving - the patient and the research assistant who attends data collection will remain blinded as will anaesthetic and nursing staff involved in the administration and charting of analgesia. It is important to note that the operating surgeon was the person who decided if a patient was eligible for inclusion in this study - however the entire process of informing the patient and obtaining their consent is completed before the patient is entered formally into the study and before the treatment arm for that patient has been determined. The surgeon needs to be aware of the treatment arm to which a patent has been allocated as they are the operator who places the catheter and loads it with the appropriate solution.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generation at time of enrollment into the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2007
Actual
31/01/2007
Date of last participant enrolment
Anticipated
Actual
31/12/2009
Date of last data collection
Anticipated
Actual
31/12/2009
Sample size
Target
50
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237538 0
Self funded/Unfunded
Name [1] 237538 0
Country [1] 237538 0
Primary sponsor type
Individual
Name
Dr Steve Smith
Address
Department of Surgery,
John Hunter Hospital,
Locked Bag 1,
New Lambton. 2305.
New South Wales.
Country
Australia
Secondary sponsor category [1] 237018 0
None
Name [1] 237018 0
Address [1] 237018 0
Country [1] 237018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243675 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 243675 0
Ethics committee country [1] 243675 0
Australia
Date submitted for ethics approval [1] 243675 0
Approval date [1] 243675 0
13/12/2006
Ethics approval number [1] 243675 0
06/12/13/5.03

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

Contacts
Principal investigator
Name 30091 0
A/Prof Stephen Smith
Address 30091 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 30091 0
Australia
Phone 30091 0
+61 2 49236397
Fax 30091 0
Email 30091 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au
Contact person for public queries
Name 13338 0
Stephen Smith
Address 13338 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 13338 0
Australia
Phone 13338 0
+61 2 49236397
Fax 13338 0
Email 13338 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 4266 0
Stephen Smith
Address 4266 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 4266 0
Australia
Phone 4266 0
+61 2 49236397
Fax 4266 0
Email 4266 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
data
When will data be available (start and end dates)?
as required
Available to whom?
Other researchers
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
electronic data reports


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.