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Trial registered on ANZCTR


Registration number
ACTRN12617000974303
Ethics application status
Approved
Date submitted
22/06/2017
Date registered
6/07/2017
Date last updated
19/03/2021
Date data sharing statement initially provided
19/03/2021
Date results information initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a postoperative local anaesthetic pain pump in anterior total hip arthroplasty:
A Randomised Control Trial
Scientific title
A Randomised control trial on effect of Local infiltration anaesthetic (LIA) versus LIA + 48 hours infusion of local anaesthetic postoperatively on opioid consumption after anterior approach total hip replacement
Secondary ID [1] 292267 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip arthritis
 303787 0
Condition category
Condition code
Surgery 303156 303156 0 0
Other surgery
Musculoskeletal 303219 303219 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised control trial analysing the difference in pain and length of stay in patients who have undergone an anterior total hip replacement (THR) with 2 different modes of analgesia post-operatively. One group of participants (Group A) will receive local infiltration anaesthetic (LIA) whilst the second cohort (Group B) will receive LIA and a continuous infiltration of LIA via an elastomeric pump directly to the surgical site.
Participants in Group A will receive 0.2% Ropivacaine 2mg/kg as a once-off infiltration directly to the wound site intra-operatively. Participants in Group B will also receive 0.2% Ropivacaine 2mg/kg as a once-off infiltration directly to the wound site intra-operatively as well as having a an elastometric pump containing 0.2% Ropivacaine directly inserted in the wound site to provide continuous infiltration. The elastometric pump will contain 400ml of Ropivacaine and be infused with a rate of 2-14ml/hr. The infusion rate will commence at 2ml/hr initially post-operatively and can be increased by the nursing staff if participants are complaining of increased pain and require further analgesia to help control this.

The study aims to investigate whether adding a continuous infiltration of LIA to surgical patients post anterior THR adds any additional reduction in pain, reduction in opioid usage and reduced length of stay compared to LIA alone.

108 patients will be recruited from the private outpatient rooms of a consultant orthopaedic surgeon that specialises in anterior THR. Participants will be randomly computer generated into one of the two different cohort groups and will receive either LIA or LIA + Elastomeric pump post-operatively. The elastomeric pump will be placed intra-operatively and remain insitu for 48hours post-operatively. The current post-operative standard of care involves patients reporting verbal analogue pain scales (VAS) from zero to ten, daily physiotherapy and administration of analgesia by nursing staff. This current practice will remain unchanged in this study. Pain reported scales, length of stay and opioid usage will be recorded in the two cohorts and compared.
Data will be correlated between the two cohorts and analysed to determine whether participants who had LIA + Elastomeric pump had a reduction in pain scales, opioid usage, and reduced length of stay.
Intervention code [1] 298445 0
Treatment: Devices
Intervention code [2] 298491 0
Treatment: Drugs
Comparator / control treatment
The control group consists of 54 patients who will undergo an anterior total hip replacement and receive local infiltration anaesthetic intra-operatively only and will not have an elastomeric pump inserted.
Control group
Active

Outcomes
Primary outcome [1] 302527 0
Compare opioid consumption between 2 cohort groups who have had an anterior total hip replacement, where one group has received Local infiltration anaesthetic (LIA) only and the other has received LIA + an 48-hour infusion pump. This outcome will be assessed by adding the total consumption of analgesia a participant has used as recorded on the hospital's drug chart and converting it into an oral morphine equivalent dose.
Timepoint [1] 302527 0
48 hours post-operatively
Secondary outcome [1] 336306 0
Post-operative pain scores as assessed on the verbal reported scale (VRS) which consists of a score from 0-10 where 0 = no pain, 5 = moderate pain and 10 = severe pain.
Timepoint [1] 336306 0
This score is initially taken in the first 30 minutes post-operatively then every 1 hour for the next 2 hours and then again every 4 hours thereafter until the participant is discharged home.
Secondary outcome [2] 336469 0
Length of hospital admission will be assessed by calculating how many days the participant was an inpatient from the day the participant underwent their surgery till the day they were discharged home.
Timepoint [2] 336469 0
At discharge from the hospital
Secondary outcome [3] 393074 0
Anti-emetic usage between cohorts was assessed by adding how many anti-emetic tablets each participant consumed on their drug chart from post-operation until time of discharge.
Timepoint [3] 393074 0
At time of discharge
Secondary outcome [4] 393075 0
laxative usage between cohorts was assessed by adding how many laxative tablets each participant consumed on their drug chart from post-operation until time of discharge.
Timepoint [4] 393075 0
At time of discharge

Eligibility
Key inclusion criteria
Participants must be greater than 18 years old, have hip osteoarthritis as assessed by the principal investigator and able to give informed consent to undergo an Anterior THR.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy or intolerance to Ropivicaine, and patients who have been diagnosed with Chronic Regional Pain Syndrome (CRPS)

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 principal investigator who will enrol participants will be concealed of the treatment cohort the participant will be allocated to and will not find out until the day of the surgery by a central computerised program that uses a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using simple randomisation by a computerised sequence generation. This will occur centrally via an online program through Sealed Envelope (https://www.sealedenvelope.com). The principal investigator will be informed which group the participant is to be randomised into via text message and/or email from this website.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint is total postoperative opioid usage for each participant converted to an oral morphine equivalent dose. Previous studies have found that oral morphine equivalent consumption was 0 – 90 mg (min 30mg, SD 23mg) during 0 – 24 h in patients receiving continuous wound local anaesthetic infiltration (Ref: Bianconi, Anderson). Therefore, assuming that the total morphine consumption in the LIA + On-Q group is 30 mg, a difference between the groups of 30 mg was considered to be significant. Using unpaired t-test and assuming alpha of 0.05 and statistical power of 80%, we calculated that we would need a total of 108 patients (54 in each group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2017
Actual
28/08/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
29/05/2018
Date of last data collection
Anticipated
7/04/2018
Actual
29/05/2018
Sample size
Target
108
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8432 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment postcode(s) [1] 16504 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 296814 0
Self funded/Unfunded
Name [1] 296814 0
None
Country [1] 296814 0
Primary sponsor type
Individual
Name
Mr Phong Tran
Address
Footscray Hospital,
Orthopaedic Unit,
159 Gordon St,
Footscray
VIC 3011
Country
Australia
Secondary sponsor category [1] 295866 0
Hospital
Name [1] 295866 0
St Vincent's Private Hospital Melbourne
Address [1] 295866 0
159 Grey St,
East Melbourne
VIC 3002
Australia
Country [1] 295866 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298049 0
St Vincent's Melbourne Human Research Ethics Committee
Ethics committee address [1] 298049 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 298049 0
Australia
Date submitted for ethics approval [1] 298049 0
19/04/2017
Approval date [1] 298049 0
07/08/2017
Ethics approval number [1] 298049 0
HREC/17/SVHM/97

Summary
Brief summary
This study aims to to determine whether using Local infiltration anaesthetic (LIA) vs LIA + continuous post-operative infusion of local anaesthetic for 48 hours using an elastomeric pump effects pain, opioid usage and, length of stay after a total hip replacement via the anterior approach.

Each participant will be randomly selected into one of 2 groups. Group A will receive local infiltration anaesthetic to the surgical site during the operation, whilst Group B will receive local infiltration anaesthetic during the operation as well as an On-Q pump wound catheter that will provide continuous local anaesthetic to the surgical site for 48 hours after the surgery. After 48 hours, the On-Q pump will then be removed by the nursing staff on the ward by simple extraction.

The Primary Outcome for this study will be opioid consumption between the 2 cohort groups. This outcome will be measured by calculating the total opioid usage for each participant and converting this to an oral morphine equivalent dose.

The Secondary outcomes for this study are length of hospital stay measured from the admission day to the day of discharge from the ward, pain scores measured on the Verbal Analogue Scale (VAS), anti-emetic and laxative usage. The VAS consists of an individual subjective scale where each participant reports their level of pain from 0 to 10 where 0 = no pain, 5 = moderate pain and 10 = severe pain.

Research information collected for this study consist of the VAS, opioid consumption, anti-emetic and laxative usage which are all information that is documented on standard protocol forms belonging to St Vincent’s Hospital (Observation Chart and Drug Chart). No new questionnaires or forms have been created for this study. Results from the 2 cohorts will then be collated and compared between the cohorts to see if adding a 48 hour infusion pump does reduce pain, opioid usage and length of stay.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1837 1837 0 0
/AnzctrAttachments/373190-RCT LIA vs LIA + On-Q in Anterior THR.doc (Protocol)

Contacts
Principal investigator
Name 75818 0
Mr Phong Tran
Address 75818 0
St Vincent's Private Hospital - East Melbourne Campus
166 Gipps St
East Melbourne
VIC 3002
Country 75818 0
Australia
Phone 75818 0
+61(03)99286163
Fax 75818 0
Email 75818 0
[email protected]
Contact person for public queries
Name 75819 0
Maya Keeka
Address 75819 0
Footscray Hospital
Orthopaedic Unit
159 Gordon St
Footscray
VIC 3011
Country 75819 0
Australia
Phone 75819 0
+61(03)83456666
Fax 75819 0
Email 75819 0
[email protected]
Contact person for scientific queries
Name 75820 0
Phong Tran
Address 75820 0
St Vincent's Private Hospital - East Melbourne Campus
166 Gipps St
East Melbourne
VIC 3002
Country 75820 0
Australia
Phone 75820 0
+61(03)99286163
Fax 75820 0
Email 75820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Verbal reported pain scores
Opioid consumption over 48hours in total morphine equivalent dosage
Length of admission
When will data be available (start and end dates)?
Data will be available immediately from publication
No end date determined
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11083Study protocol    373190-(Uploaded-08-03-2020-00-56-07)-Study-related document.doc
11084Informed consent form    373190-(Uploaded-08-03-2020-01-07-45)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373190-(Uploaded-08-03-2020-01-21-13)-Basic results summary.docx
Plain language summaryNo We conducted a study to see if adding a pain pump ... [More Details]

Documents added automatically
No additional documents have been identified.