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Trial registered on ANZCTR


Registration number
ACTRN12618000111279
Ethics application status
Approved
Date submitted
11/12/2017
Date registered
25/01/2018
Date last updated
25/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of timed intermittent boluses of regional local anaesthetic (TIBRA) versus continuous infusion of local anaesthetic via transversus abdominis catheters following major liver surgery
Scientific title
Comparison of post operative pain scores with timed intermittent boluses of regional local anaesthetic (TIBRA) versus continuous infusion of local anaesthetic via transversus abdominis catheters following major liver surgery.
Secondary ID [1] 293483 0
Nil known
Universal Trial Number (UTN)
U1111-1205-9175
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary surgery 305823 0
Condition category
Condition code
Anaesthesiology 305037 305037 0 0
Pain management
Oral and Gastrointestinal 305148 305148 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
Trial participants will be patients undergoing hepatobiliary surgery with a right subcostal incision. All patients included in trial will have a surgically placed transversus abdominis plane (TAP) catheter inserted at the end of the surgical procedure. They will have been randomised into two groups. One group will receive a continuous infusion of 0.2% ropivicaine at 5mls per hour via TAP catheter. The second group will be given intermittent boluses of 20mls of 0.2% ropivicaine every 4 hours via TAP catheter. The total daily dose of ropivicaine will be the same. The infusion pumps will programmed by the the treating anaesthetist who will not be blinded to the group allocation, but will have no involvement in the patients care once they have left the theatre recovery area. The infusions will continue for 72 hours after surgery and then catheters will then be removed by the ward nurses. The patients will be visited daily by the Acute Pain Service nurses and doctors. They will check the pump settings and connections, and the catheter insertion site. A separate nurse from the pain service who is blinded to the group allocation will be the one who collects data on each patient.
Intervention code [1] 299834 0
Treatment: Drugs
Comparator / control treatment
The control group will be the group receiving a continuous 5ml regional infusion of ropivicaine via TAP catheter, as outlined above. This is standard practice at our institution currently.
Control group
Active

Outcomes
Primary outcome [1] 304201 0
Self reported pain score on cough. We will use the Likert pain score 0-10.
A score of 0 implies no pain, with 10 being the 'worst pain imaginable.'
Timepoint [1] 304201 0
On the morning of post-operative day 1, day 2 and day 3 the patients will be asked to self report their pain during a cough. The primary time point will be the morning of Day 1.
Secondary outcome [1] 341223 0
Self reported pain at rest. We will use the Likert pain score 0-10.
A score of 0 implies no pain, with 10 being the 'worst pain imaginable.'
Timepoint [1] 341223 0
On the morning of post-operative day 1, day 2 and day 3 the patients will be asked to self report their pain at rest
Secondary outcome [2] 341224 0
24hr dose of opioid anaglesia via Patient Controlled Analgesia (PCA) pump. These will be programmed to deliver 1mg of oxycodone when the patient presses the button, with a 5 minute lockout. This is a standard program at our hospital.
Timepoint [2] 341224 0
On the mornings of days 1,2 and 3 the research nurse will document the usage of oxycodone from the PCA pump for the preceeding 24 hours.
Secondary outcome [3] 341225 0
The patients will be asked to score the severity of opioid side effects; nausea/itch/sedation as being mild/moderate/severe.
Timepoint [3] 341225 0
Morning of day 1, day 2, day 3
Secondary outcome [4] 342398 0
Time to return of bowel function. The question will be asked whether bowels have been opened - yes or no.
Timepoint [4] 342398 0
Morning of Day 1, day 2 and day 3

Eligibility
Key inclusion criteria
Liver resection or biliary surgery requiring right subcostal incision
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major liver resection resulting in reduced liver function
Major liver dysfunction
Laparoscopic surgery
Renal failure requiring dialysis
Incision crossing the midline to left subcostal region

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations based on prior studies have shown that a sample size of 13 in each group will have a 90% power to detect a difference in means of 2, assuming the common standard deviation is 1.67 using a two-group t-test, with a 0.05 one-sided significance level. We aim to include more than twice the required sample size due to an anticipated drop out rate of 10%, and previously reported study with a catheter failure rate of 45%.
Initial statistical analysis will be to compare the means of pain scores on days 1,2 and 3 between the two groups.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 9525 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 18275 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 298102 0
Commercial sector/Industry
Name [1] 298102 0
Competitive Grant from Smith Medical
Address [1] 298102 0
6000 Nathan Lane N
Minneapolis
Minnesota
55442
Country [1] 298102 0
United States of America
Primary sponsor type
Individual
Name
Dr Emilia Reece
Address
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 297179 0
Individual
Name [1] 297179 0
Associate Professor Paul Gray
Address [1] 297179 0
Tess Cramond Multidisciplinary Pain Centre
Level 4
James Mayne Building
Royal Brisbane and Womens Hospital,
Bowen Bridge Road
Herston
QLD 4029


Country [1] 297179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299122 0
Metro South HREC
Ethics committee address [1] 299122 0
Centre for Health Research
Translational Research Institute
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Ethics committee country [1] 299122 0
Australia
Date submitted for ethics approval [1] 299122 0
14/07/2017
Approval date [1] 299122 0
17/10/2017
Ethics approval number [1] 299122 0
HREC/17/QPAH/458

Summary
Brief summary
The incision for major hepatobiliary surgery is across the right upper quadrant of the abdomen extending up the midline. Due to its size and position this incision can be very painful and affect normal breathing and mobilization. Inadequate control of pain can lead to impairment of ventilatory capacity with subsequent respiratory complications. Regional anaesthesia is often employed to improve pain control. It also has the benefit of reducing the requirement for opioids and therefore reducing opioid side effects, such as nausea, constipation and itch. Transversus abdominis plane (TAP) catheters have been found to be non-inferior to epidural anaesthesia for abdominal surgery. Current standard of practice at our institution is to place a TAP catheter and infuse a slow continuous infusion of local anaesthetic via a volumetric pump at a fixed rate. However, it is not known whether the most effective method of delivering local anaesthetic is via continuous infusion or intermittent bolus. Intermittent bolus has the presumed benefit of volume effect and further spread and therefore may provide better analgesia. We plan to compare timed intermittent boluses of regional anaesthesia (TIBRA) to a slow continuous infusion of local anaesthetic in terms of analgesic efficacy and opioid requirement.
From January ’18, all eligible patients undergoing major hepatobiliary surgery will be identified in surgical clinic and invited to participate. The study is anticipated to run for 12 months.
Participants will be randomised into either continuous or intermittent bolus group. The participants will not know which group they have been randomised to. Each day they will be visited by a member of the research team and asked to score their level of pain on a numerical rating scale. The total dose of other painkillers required will be documented, and they will be asked about any side effects they may have from these medications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79370 0
Dr Emilia Reece
Address 79370 0
Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 79370 0
Australia
Phone 79370 0
+61731767095
Fax 79370 0
Email 79370 0
emilia.reece@health.qld.gov.au
Contact person for public queries
Name 79371 0
Dr Emilia Reece
Address 79371 0
Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 79371 0
Australia
Phone 79371 0
+61731767095
Fax 79371 0
Email 79371 0
emilia.reece@health.qld.gov.au
Contact person for scientific queries
Name 79372 0
Dr Emilia Reece
Address 79372 0
Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 79372 0
Australia
Phone 79372 0
+61731767095
Fax 79372 0
Email 79372 0
emilia.reece@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable