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Trial registered on ANZCTR


Registration number
ACTRN12613000380796
Ethics application status
Approved
Date submitted
2/04/2013
Date registered
9/04/2013
Date last updated
17/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial to compare post-operative respiratory function following bolus abdominal block local anaesthesia, versus standard infusional abdominal block local anaesthesia in patients undergoing gastrointestinal resectional surgery
Scientific title
A Randomised Trial to compare post-operative respiratory function in patients receiving bolus abdominal block local anaesthesia, to patients receiving the standard infusional abdominal block local anaesthesia in patients undergoing gastrointestinal resectional surgery
Secondary ID [1] 281835 0
JHGIS03
Universal Trial Number (UTN)
Trial acronym
ABBI Study
(Abdominal Block Bolus Infusion Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal resectional surgery 288191 0
Condition category
Condition code
Anaesthesiology 288555 288555 0 0
Pain management
Surgery 288556 288556 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B is intervention: abdominal wall block by bolus administration of the local anaesthetic agent ropivacaine 0.2% every 6 hours until block is removed.
Boluses are 20mls of 0.2% ropivacaine through each catheter for bilateral catheters, and 40mls of 0.2% ropivacaine for unilateral catheters.

A maximum dose of 0.2% ropivacaine for intervention arm is 3mg/kg for each bolus dose.
Intervention code [1] 286393 0
Treatment: Drugs
Comparator / control treatment
Arm A is control, abdominal wall block by infusion of local anaesthetic.
Infusion is given via controlled infusion pump, using 0.2% ropivacaine at 5ml/hr for bilateral catheters through each catheter, and 0.2% ropivacaine at 10ml/hr for unilateral catheters. Infusionmay last up to 5 days post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 288715 0
The difference between baseline pre-operative and post-operative forced expiratory volume in first second (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) as measured by hand-held spirometer.
Timepoint [1] 288715 0
Pre-operative baseline and post-operative days 1, 2 and 3
Secondary outcome [1] 300808 0
Daily postoperative analgesic consumption (MilliEquivalents of Morphine)
Timepoint [1] 300808 0
Post-operative days 1, 2 and 3
Secondary outcome [2] 300809 0
Daily abdominal wall/wound site pain as assessed using a Visual Analogue Score
Timepoint [2] 300809 0
Post-operative days 1, 2 and 3
Secondary outcome [3] 300810 0
Daily mobility score using the DEMMI Scale (DeMorton Mobility Index)
Timepoint [3] 300810 0
Post-operative days 1, 2 and 3
Secondary outcome [4] 300813 0
Time to first flatus (hours)
Timepoint [4] 300813 0
Post-operative days 1, 2 and 3
Secondary outcome [5] 300814 0
Time to first bowel motion (hours)
Timepoint [5] 300814 0
Post-operative days 1, 2 and 3
Secondary outcome [6] 300815 0
Rates of ileus as assessed by lack of any evidence of gut function >48 hours
Timepoint [6] 300815 0
Post-operative day 2
Secondary outcome [7] 300817 0
Post-operative nausea and vomiting (PONV) as assessed by the Simplified PONV Scale
Timepoint [7] 300817 0
Post-operative days 1, 2 and 3
Secondary outcome [8] 300819 0
Length of hospital stay (days)
Timepoint [8] 300819 0
Post-operative period
Secondary outcome [9] 300820 0
Complications as assessed by the Clavien-Dindo Classification of Surgical Complications.
Timepoint [9] 300820 0
Assessed up to Day 30
Secondary outcome [10] 300821 0
Patient satisfaction with analgesia (Likert scale and percent satisfaction)
Timepoint [10] 300821 0
Post-operative days 1, 2 and 3 and Day 30
Secondary outcome [11] 300822 0
Cost comparison (total inpatient cost including consumables, staff related costs, bed day costs)
Timepoint [11] 300822 0
After patient discharge

Eligibility
Key inclusion criteria
All patients undergoing elective or semi-urgent booked abdominal gastrointestinal resectional surgery at the following institutions:
- John Hunter Hospital
- Newcastle Private Hospital
- Belmont District Hospital
- The Calvary Mater Newcastle
- Lake Macquarie Private Hospital
- The Maitland Hospital
- Maitland Private Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Refusal or unable to give written, informed consent to participate in the study, or
- Patient has received an epidural, spinal or other neuroaxial anaesthetic
- Patient is under 18 years of age, or
- Patient receives an operation that involves extra incisions outside the abdominal wall (such as abdomino-perineal resections), or
- Patient has a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or
- Patient has a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
- Patient remains intubated post procedure
- Patient is taking regular opiate narcotics pre-operatively

Patients will be withdrawn from the trial if: - At any time they wish to discontinue with the trial, or Post-operative complications within the first 72 hours result in the patient being unable to be assessed for study outcomes (e.g. requiring post-operative ventilation)

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)
Patients will the be randomised into treatment arms A or B after being stratified for site of incision and type of block (TAP or RSB). Randomisation will be performed by the Anaesthetist, after placement of the catheter/s, via a centralised web-based randomisation program using a secure login.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated in blocks for each arm, with randomisation to control and intervention in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on data from a randomised controlled trial just published looking at wound infusions for postoperative pain management in colorectal surgery patients which reported an FEV1 standard deviation of 0.5707 , it has been calculated that 50 subjects per group are required in order to detect what is perceived as a clinically relevant difference in FEV1 of 400ml per group (90% power, p<0.05)
Assuming 20% dropout to follow up, recruitment is aimed at 120 patients to allow for a lost to follow-up or consent withdrawals.

Data analysis on the all data will consist of Chi Square and Fishers exact tests to compare categorical data. Continuous data conforming to a normal distribution will be compared using Student's T test.
Data that does not conform to a normal distribution will be analysed with the Mann-Whitney U-test for non-parametric data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2013
Actual
9/04/2013
Date of last participant enrolment
Anticipated
Actual
13/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 472 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 473 0
Belmont Hospital - Belmont
Recruitment hospital [3] 474 0
The Maitland Hospital - Maitland
Recruitment hospital [4] 475 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [5] 476 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [6] 477 0
Maitland Private Hospital - East Maitland
Recruitment hospital [7] 829 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 6605 0
2298 - Waratah
Recruitment postcode(s) [2] 6606 0
2280 - Belmont
Recruitment postcode(s) [3] 6607 0
2320 - Maitland
Recruitment postcode(s) [4] 6608 0
2305 - New Lambton
Recruitment postcode(s) [5] 6609 0
2290 - Gateshead
Recruitment postcode(s) [6] 6610 0
2323 - Ashtonfield
Recruitment postcode(s) [7] 6643 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 286619 0
Self funded/Unfunded
Name [1] 286619 0
Country [1] 286619 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Local Health District
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 285777 0
None
Name [1] 285777 0
Address [1] 285777 0
Country [1] 285777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288997 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288997 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 288997 0
Australia
Date submitted for ethics approval [1] 288997 0
Approval date [1] 288997 0
19/12/2012
Ethics approval number [1] 288997 0
12/12/12/3.02

Summary
Brief summary
The study is trying to find out which is the best way to deliver a medication for pain relief called a local anaesthetic (a drug that helps to numb areas of the body e.g. the skin) to the abdominal wall in patients undergoing major abdominal surgery in order to help reduce the post-operative pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37330 0
Dr Stephen Smith
Address 37330 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 37330 0
Australia
Phone 37330 0
+61 2 49855568
Fax 37330 0
Email 37330 0
[email protected]
Contact person for public queries
Name 37331 0
Rosemary Carroll
Address 37331 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 37331 0
Australia
Phone 37331 0
+61 2 49855568
Fax 37331 0
Email 37331 0
[email protected]
Contact person for scientific queries
Name 37332 0
Stephen Smith
Address 37332 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 37332 0
Australia
Phone 37332 0
+61 2 49855568
Fax 37332 0
Email 37332 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

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