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Trial registered on ANZCTR


Registration number
ACTRN12615001139561
Ethics application status
Approved
Date submitted
1/10/2015
Date registered
27/10/2015
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised control trial of adductor canal block versus intra-articular catheter in knee replacement surgery
Scientific title
In total knee replacement surgery does an adductor canal block or intra-articular catheter with infusions give superior analgesia and range of movement
Secondary ID [1] 287588 0
none
Universal Trial Number (UTN)
U1111-1175-1388
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 296380 0
Condition category
Condition code
Surgery 296652 296652 0 0
Other surgery
Musculoskeletal 296653 296653 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adductor canal block versus intra-articular catheter for pain relief in total knee replacement surgery. (Both treatments are given in addition to standard anaesthetic care)

Group Adductor canal block
Ultrasound guided injection into adductor canal to administer block of femoral nerve at this level of 20ml 0.375% ropivacaine with 8mg dexamethasone. Administered once only immediately prior to surgery.

Intervention code [1] 292984 0
Treatment: Drugs
Comparator / control treatment
Group intra-articular catheter (Both treatments are given in addition to standard anaesthetic care)
10ml 0.75% ropivacaine with 1mcg adrenaline and 30mg ketorolac infused via intra-articular catheter infusion immediately after closure of the wound during surgery and in addition at 24 and 36 hours post operatively.
Control group
Active

Outcomes
Primary outcome [1] 296263 0
The primary endpoints are
-a clinically and statistically significant difference in pain as measured by a visual analogue scale
Timepoint [1] 296263 0
daily for the first 3 days
then on discharge day
at 2 week follow up
at 6 weeks
at 3 months
at 6 months post operatively
Primary outcome [2] 296264 0
- a clinically and statistically significant difference in range of movement of the operated knee measured by goniometer in degrees.
Timepoint [2] 296264 0
daily for the first 3 days
then on discharge day
at 2 week follow up
at 6 weeks
at 3 months
at 6 months post operatively
Secondary outcome [1] 318011 0
- a clinically and statistically significant difference in scores on the Oxford knee score
Timepoint [1] 318011 0
pre-operatively and then
at 2 week follow up
at 6 weeks
at 3 months
and at 6 months post operatively
Secondary outcome [2] 318012 0
-Use of breakthrough analgesia as measured by doses of patient controlled analgesia administered / use of PRN analgesia.
Timepoint [2] 318012 0
daily for the first 3 days
then on discharge day
at 2 week follow up
at 6 weeks
at 3 months
at 6 months post operatively

Eligibility
Key inclusion criteria
Undergoing Total knee replacement
Able to consent to inclusion in study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent to inclusion in study
Allergy to trial medications

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 will be conducted in a concealed fashion by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2015
Actual
20/07/2016
Date of last participant enrolment
Anticipated
29/06/2017
Actual
1/09/2017
Date of last data collection
Anticipated
3/03/2018
Actual
28/02/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4418 0
St John of God Hospital, Murdoch - Murdoch

Funding & Sponsors
Funding source category [1] 292150 0
Other Collaborative groups
Name [1] 292150 0
Orthopaedics Western Australia
Country [1] 292150 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orthopaedics Western Australia
Address
15/3 Barry Marshall Parade, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 290823 0
None
Name [1] 290823 0
Address [1] 290823 0
Country [1] 290823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293625 0
St John of God Hospital
Ethics committee address [1] 293625 0
100 Murdoch Dr, Murdoch WA 6150
Ethics committee country [1] 293625 0
Australia
Date submitted for ethics approval [1] 293625 0
16/11/2015
Approval date [1] 293625 0
09/12/2015
Ethics approval number [1] 293625 0

Summary
Brief summary
Participation will involve being randomly assigned to one of two routinely used pain management protocols to provide pain relief in the period immediately after total knee replacement surgery. Participants will be unaware as to which group they are in. A pain specialist doctor and nurse will assess pain control and range of movement of the knee at regular intervals following the surgery. This will assist surgeons and anaesthetists to determine the most effective regimen for future patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60774 0
Dr Samuel Duff
Address 60774 0
Orthopaedics WA
15/3 Barry Marshall Parade,
Murdoch WA 6150
Country 60774 0
Australia
Phone 60774 0
+61427771900
Fax 60774 0
Email 60774 0
[email protected]
Contact person for public queries
Name 60775 0
Samuel Duff
Address 60775 0
Orthopaedics WA
15/3 Barry Marshall Parade,
Murdoch WA 6150
Country 60775 0
Australia
Phone 60775 0
+61427771900
Fax 60775 0
Email 60775 0
[email protected]
Contact person for scientific queries
Name 60776 0
Samuel Duff
Address 60776 0
Orthopaedics WA
15/3 Barry Marshall Parade,
Murdoch WA 6150
Country 60776 0
Australia
Phone 60776 0
+61427771900
Fax 60776 0
Email 60776 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.