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Trial registered on ANZCTR


Registration number
ACTRN12616000610437
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
10/05/2016
Date last updated
21/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal Duration of Adductor Canal Catheter Infusions for analgesia following Knee Arthroplasty
Scientific title
A prospective randomized controlled trial to compare 3 day vs 5 day adductor canal catheter infusions following knee arthroplasty
Secondary ID [1] 288874 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee arthroplasty 298168 0
post-operative pain 298229 0
Condition category
Condition code
Anaesthesiology 298333 298333 0 0
Pain management
Surgery 298364 298364 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block (ACB) infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength and capacity to walk.
Intervention group will receive ACB Initial bolus = 30mls x 0.2% ropivacaine then continuous Infusion = 0.2% @ 6mls/h) for 5 days by an anaesthetist and monitored by an Acute Pain Service.
Intervention code [1] 294334 0
Treatment: Drugs
Comparator / control treatment
Control group will have standard care, which is only 3 days duration of ACB contuinuous low dose ropivacine infusion (Initial bolus = 30mls x 0.2% ropivacaine then continuous Infusion = 0.2% @ 6mls/h) for 3 days admisintered by an anaesthetist and monitored by an Acute Pain Service.
Control group
Active

Outcomes
Primary outcome [1] 297808 0
Pain intensity when walking via numerical rating score 0-10
Timepoint [1] 297808 0
Preop, Day 3-6, 3 Month post-op
Rated once each timepoint based on pain experienced in past 24 hours
Primary outcome [2] 297809 0
Walking activity via accelerometer measuring % time active/ day
Timepoint [2] 297809 0
Preop, Day3-6, 3 months post-op.
Activity monitor will be worn continuously for 7 days at preop baseline and 3 month
Outcome will be continuously worn from eve of post-operative Day 3 to morning of Day 6 to capture activity level each day.
Secondary outcome [1] 322291 0
Hospital length of stay as calculated as the difference in whole days from the date the patient is admitted for surgery to the day they leave the hospital setting.
Timepoint [1] 322291 0
Discharge day
Secondary outcome [2] 322292 0
Recovery quality (QoR-15, Opioid Related Symptom Distress Scale) Modified to rate over last 48 hours
Timepoint [2] 322292 0
Post-op Day 3 and 6
Secondary outcome [3] 322293 0
Satisfaction with pain regime over the last 24 hours via numerical rating score 0-10
Timepoint [3] 322293 0
At beginning each day, once on Days 3-6 Post-op

Eligibility
Key inclusion criteria
1. The individual has signed a Patient Informed Consent (PIC) specific to this study, and approved by the Institutional Ethics Review Board.
2. The individual clinically qualifies for elective unilateral primary or single-stage revision TKA surgery based on physical examination and medical history.
3. American Society Anaesthetists Score 1-3
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous major ipsilateral knee surgery.
2. Pre-existing neuropathy of the operative limb
3. Revision surgery for infection.
4. Allergy or sensitivity to local anaesthetics
5. The individual is a prisoner, physically or mentally compromised (i.e., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse), and is unwilling or unable to comply with scheduled evaluations and/or rehabilitation.
6. Patients with comorbidities causing severe mobility impairment

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)
Following consent by th esurgeon, patient assignment to either 3 day or 5 day infusion was made by an independent researcher using a computer-generated sequence list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomisation list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The study design to establish superiority of the 5 day duration, powered to detect a 15% difference in NRS. To achieve Power (1 - ß) = 0.80, a = .05 if there were a benefit of 1.5 to for the 5-day condition then data would be expected to liken to 3-day group ( M1 = 3, SD1 = 2) verses the 5-day group( M2 = 1.5, SD2 = 2) This would provide effect size (d) of .75 (where .80 is large).To detect this effect the recommended sample size is 29 per condition. This we aim to recruit 32 participants to each group, allowing for 10% attrition.

Recruitment
Recruitment status
Completed
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)
WA
Recruitment hospital [1] 5508 0
Hollywood Private Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 293227 0
Other
Name [1] 293227 0
The Joint Studio
Address [1] 293227 0
1/ 85 Monash Ave
Nedlands WA 6009
Country [1] 293227 0
Australia
Primary sponsor type
Other
Name
The Joint Studio
Address
1/ 85 Monash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 292028 0
None
Name [1] 292028 0
Address [1] 292028 0
Country [1] 292028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294706 0
Hollywood Private Hospital HREC
Ethics committee address [1] 294706 0
Hospital Ave, Nedlands WA 6009
Ethics committee country [1] 294706 0
Australia
Date submitted for ethics approval [1] 294706 0
18/05/2016
Approval date [1] 294706 0
07/07/2016
Ethics approval number [1] 294706 0

Summary
Brief summary
There is a wide range of local analgesic techniques available for analgesia following total knee arthroplasty (TKA). In a recent review article, continuous femoral nerve block analgesia has been described as the ‘gold standard’.. A myriad of combinations of these techniques appear in the literature and all have some limitations.

Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength. Patients are able to walk independently while these infusions are running with limited pain. This is transforming post-operative care for these patients.

We have audited 3 day infusions in this group of patients and found improvements in pain and mobility. We believe that prolonging the infusion duration may provide further benefits to patients.

The primary aim of this trial is to assess whether a 5 day ACB infusion is better than a 3 day infusion in terms of quality of analgesia and their walking activity level during the first week following their surgery. Our secondary aims are to evaluate safety of the technique and to ascertain if any benefits are carried over to the 3 month pain, walking level, hip function and satisfaction levels.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64762 0
Dr Mark Lennon
Address 64762 0
Anaesthetics Department
Hollywood Private Hospital
Monash Ave, Nedlands WA 6009
Country 64762 0
Australia
Phone 64762 0
+61 408230564
Fax 64762 0
Email 64762 0
mjlennon007@gmail.com
Contact person for public queries
Name 64763 0
Ms Samantha Haebich
Address 64763 0
The Joint Studio
1/ 85 Monash Ave Nedlands WA 6009
Country 64763 0
Australia
Phone 64763 0
+61 8 64609781
Fax 64763 0
Email 64763 0
Research@thejointstudio.com.au
Contact person for scientific queries
Name 64764 0
Dr Scott Sargant
Address 64764 0
Anesthetics Department
Hollywood Private Hospital
Monash Ave,Nedlands WA 6009
Country 64764 0
Australia
Phone 64764 0
61 8 9386 6000
Fax 64764 0
Email 64764 0
scottsargant77@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary