ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

Pain management

Oral and Gastrointestinal

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]

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]

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]

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]

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]

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]

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]

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]

The patients will be asked to score the severity of opioid side effects; nausea/itch/sedation as being mild/moderate/severe.

Timepoint [3]

Morning of day 1, day 2, day 3

Secondary outcome [4]

Time to return of bowel function. The question will be asked whether bowels have been opened - yes or no.

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

22/02/2018

Actual

Date of last participant enrolment

Anticipated

28/12/2018

Actual

Date of last data collection

Anticipated

1/01/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Competitive Grant from Smith Medical

Address [1]

6000 Nathan Lane N
Minneapolis
Minnesota
55442

Country [1]

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]

Individual

Name [1]

Associate Professor Paul Gray

Address [1]

Tess Cramond Multidisciplinary Pain Centre
Level 4
James Mayne Building
Royal Brisbane and Womens Hospital,
Bowen Bridge Road
Herston
QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South HREC

Ethics committee address [1]

Centre for Health Research
Translational Research Institute
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/07/2017

Approval date [1]

17/10/2017

Ethics approval number [1]

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

Dr Emilia Reece

Address

Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731767095

Fax

emilia.reece@health.qld.gov.au

Contact person for public queries

Name

Emilia Reece

Address

Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731767095

Fax

emilia.reece@health.qld.gov.au

Contact person for scientific queries

Name

Emilia Reece

Address

Department of Anaesthesia
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731767095

Fax

emilia.reece@health.qld.gov.au

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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Documents added automatically

No additional documents have been identified.

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