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Trial registered on ANZCTR


Registration number
ACTRN12618000389202
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
15/03/2018
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intraperitoneal instillation of local anaesthetic (IPILA) in laparoscopic bariatric surgery
Scientific title
Intraperitoneal instillation of local anaesthetic (IPILA) in laparoscopic bariatric surgery and reduction in post operative pain
Secondary ID [1] 293085 0
Nil known
Universal Trial Number (UTN)
U1111-1203-3157
Trial acronym
IPILA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric surgery 305016 0
Post-operative pain 305017 0
Obesity 307032 0
Condition category
Condition code
Anaesthesiology 304338 304338 0 0
Pain management
Surgery 304339 304339 0 0
Surgical techniques
Diet and Nutrition 306133 306133 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective double-blinded clinical randomised control trial will be conducted to compare intraperitoneal instillation of ropivacaine to normal saline in 120 patients undergoing bariatric surgery.
The amount of 0.2% ropivacaine used for intra-peritoneal instillation will be administered according to patient weight at 0.5ml/kg. This will be instilled in and around the esophageal hiatus once at the conclusion of the laparoscopic bariatric procedure. Instillation will occur using a mixing cannula.
The amount of ropivacaine will be personalised to each patient by weight to ensure toxic doses are not breached and to accomodate for weight based diffusion variability between patients. The patient's weight will be recorded the day of the intervention and appropriate ml/kg amount of the unidentified drug/saline will be administered.
A research nurse will be present to monitor adherence to the specified intervention regimen,
Intervention code [1] 299325 0
Treatment: Surgery
Intervention code [2] 300622 0
Treatment: Drugs
Comparator / control treatment
The control treatment will be instillation of normal saline into the oesophageal hiatus using an mixing cannula at the conclusion of the surgery. This will also be based on weight due to the blinding of the study.
A research nurse will be present to monitor adherence to the specified intervention regimen,
Control group
Placebo

Outcomes
Primary outcome [1] 303599 0
Post-operative pain assessed using the 100mm visual analogue scale
Timepoint [1] 303599 0
Post-operatively in recovery at 1 & 2 hours and at 4, 8, 24, 48 hours.
Secondary outcome [1] 339542 0
Morphine consumption or morphine equivalents post-operatively in mg/kg which will be assessed by examining post-operative medication charts and patient records.
Timepoint [1] 339542 0
In recovery at 2 hours and at 24 and 48 hours post-operatively.
Secondary outcome [2] 339543 0
Length of stay post-operatively which will be assessed by examining patient's hospital records.
Timepoint [2] 339543 0
Measured at time of discharge

Eligibility
Key inclusion criteria
Patients who are undergoing a laparoscopic bariatric procedure through Riverina Bariatrics
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergy to local anaesthetic, severe cardiovascular disease (congestive heart failure or ischaemic heart disease), chronic renal disease (creatinine clearance <60 mL/h), child-Pugh Score B/C and if the participant declined to participate.

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)
Allocation concealed using a blank unlabelled medication bottle with the allocator offsite
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Demographic and other baseline characteristics will be summarised by assigned treatment group. Categorical variables will be summarised by frequencies and percentages. Continuous data will be summarised by mean and standard deviation.
Comparison of the primary end-point of the two groups will be conducted using a difference of two means z-test.

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9171 0
Calvary Private Hospital - Wagga Wagga
Recruitment postcode(s) [1] 17684 0
2650 - Wagga Wagga

Funding & Sponsors
Funding source category [1] 297705 0
Commercial sector/Industry
Name [1] 297705 0
Riverina Bariatrics
Address [1] 297705 0
Suite 18, 2 Docker Street, Wagga Wagga, NSW 2650
Country [1] 297705 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Williams
Address
Suite 18, 2 Docker St, Wagga Wagga, NSW 2650
Country
Australia
Secondary sponsor category [1] 296738 0
University
Name [1] 296738 0
University of Notre Dame
Address [1] 296738 0
40 Hardy Ave, Wagga Wagga NSW 2650
Country [1] 296738 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298777 0
University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 298777 0
19 Mouat Street (PO Box 1225) Fremantle WA 6959
Ethics committee country [1] 298777 0
Australia
Date submitted for ethics approval [1] 298777 0
02/04/2018
Approval date [1] 298777 0
16/10/2018
Ethics approval number [1] 298777 0
Reference Number: 018114S

Summary
Brief summary
Effective postoperative pain management continues to be an issue in laparoscopic surgery including gastric bypass. The aim of this study is to evaluate the efficacy of intraperitoneal nebulisation of ropivacaine to reduce post-operative pain in patients undergoing gastric bypass surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78202 0
Dr Nicholas Williams
Address 78202 0
Riverina Bariatrics
Suite 18, 2 Docker St
Wagga Wagga, NSW 2650
Country 78202 0
Australia
Phone 78202 0
+610269251433
Fax 78202 0
+610269251499
Email 78202 0
Nick@hwpconsulting.com.au
Contact person for public queries
Name 78203 0
Miss Ramandeep Kaur
Address 78203 0
Wagga Wagga UNSW Rural Campus
Harvey House Docker Street, Wagga Wagga NSW 2650
Country 78203 0
Australia
Phone 78203 0
+61466637686
Fax 78203 0
Email 78203 0
ramandeepkaur3462@gmail.com
Contact person for scientific queries
Name 78204 0
Miss Ramandeep Kaur
Address 78204 0
Wagga Wagga UNSW Rural Campus
Harvey House Docker Street, Wagga Wagga NSW 2650
Country 78204 0
Australia
Phone 78204 0
+61466637686
Fax 78204 0
Email 78204 0
ramandeepkaur3462@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality and ethical reasons
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable