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Trial registered on ANZCTR


Registration number
ACTRN12615000413527
Ethics application status
Approved
Date submitted
27/03/2015
Date registered
1/05/2015
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimizing post operative outcomes in Total Knee Arthroplasty (TKR) through improved pain and fatigue management: a randomized placebo controlled trial.
Scientific title
In Patients undergoing total knee arthroplasty does the addition of temazapam, amitriptyline or pregabalin in the post operative period help to improve pain and sleep, A placebo controlled trial.
Secondary ID [1] 286431 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 294599 0
Post Operative Management of Total Knee Arthroplasty 294600 0
Condition category
Condition code
Musculoskeletal 294901 294901 0 0
Osteoarthritis
Surgery 295143 295143 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a multi-centered prospective, blinded, randomized, placebo controlled trial. There are four treatment arms; placebo, temazapam, amitryptyline, and pregabalin.

Patients randomized to the placebo group will be given a single tablet administered orally once daily in the evening(NOCTE) for six weeks.

Patients randomized to the pregabalin group will be given 150mg/300mg pregabalin orally once daily (NOCTE) from day of surgery to six weeks post operatively.

Patients randomized to the temazepam group will receive 10mg/20mg once daily (NOCTE) from the day of surgery to day 14 post operatively.

Patients randomised to the amitrypyline group will receive 10mg/25mg once daily in the evening from the day of surgery to six weeks post operatively.

All treatment arms will follow a rule; patients under 70 years of age and over 70kg in weight will receive the larger dose (McEwen 70/70). E.g. Patient #01 is 61 years old and weighs 86kg, therefore they will receive the larger dose provided for their specific treatment arm.

Recruitment criteria for the study includes patients undergoing TKR. The consenting patients will be randomized to one of the four aforementioned arms. Patients will undergo the standard TKR procedure and receive post operative analgesia as per surgeons peri-operative protocol.

Sleep function will be assessed by a validated questionnaire called the Pittsburgh sleep quality index. Pain will be assessed using validated pain scores. Knee function will be assessed using the 'WOMAC' knee score.

Patients will be assessed using these scores and range of motion assessed preoperatively, at two weeks, six weeks and 3 months, and six months post-operatively.

Patients who are identified as sleeping and coping poorly (PSQI > 5) will be considered for change of management. Placebo patients will be randomised to a treatment arm, patients already in a treatment arm will have the dosage increased if suitable or will be changed to another treatment arm.

Adherence will be monitored by patient questionnaire and by drug tablet return and pill count at the two week and 6 week review.
Intervention code [1] 291509 0
Treatment: Drugs
Comparator / control treatment
Placebo - Supply to be confirmed
Control group
Placebo

Outcomes
Primary outcome [1] 294657 0
Sleep as measured by Pittsburg Sleep Quality Index
Timepoint [1] 294657 0
Assessed at 2 weeks, 6 weeks, 3 months, and 6 months post surgery. Primary timepoint: 6 months post surgery
Primary outcome [2] 294907 0
Neuropathic Pain assessed using LANSS
Timepoint [2] 294907 0
6 Months Post Surgery
Primary outcome [3] 294908 0
Knee Range Of Motion assessed with Goniometer
Timepoint [3] 294908 0
Assessed 6 Months Post Surgery
Secondary outcome [1] 313819 0
Knee function measured with IKDC and KOOS
Timepoint [1] 313819 0
6 months post surgey

Eligibility
Key inclusion criteria
Undergoing Total Knee Replacement
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of hypersensitivity to any of the medications used.
Cognitive impairment or dependent patients.
Patients with history of previous sleep disorder, depression or currently using benzodizapines, antidepressants or pregabalin.

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)
Recruitment at surgeons rooms at time of booking for surgery.

Concealed envelope system to allocate to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a Microsoft Excell to randomly a sequence and then at the point of recruitment using a concealed envelope system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Patients identified as functioning poorly will be considered for dose adjustment or change of treatment arm
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2016
Actual
13/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
34
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3615 0
Mater Hospital Pimlico - Pimlico

Funding & Sponsors
Funding source category [1] 291002 0
Charities/Societies/Foundations
Name [1] 291002 0
Orthopaedic Research Institute of Queensland (ORIQL)
Country [1] 291002 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
ORIQL
Address
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico
Queensland 4812
Country
Australia
Secondary sponsor category [1] 289680 0
Individual
Name [1] 289680 0
Dr Brent Matthews
Address [1] 289680 0
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico
Queensland 4812
Country [1] 289680 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292587 0
Mater Health Services North Queensland Human Research Ethics Committee
Ethics committee address [1] 292587 0
Ethics committee country [1] 292587 0
Australia
Date submitted for ethics approval [1] 292587 0
01/04/2015
Approval date [1] 292587 0
13/05/2015
Ethics approval number [1] 292587 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56110 0
Dr Dr Matthew Wilkinson
Address 56110 0
Orthopaedic Research Institute of Queensland.
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country 56110 0
Australia
Phone 56110 0
+61 747550564
Fax 56110 0
Email 56110 0
research_coordinator@oriql.com.au
Contact person for public queries
Name 56111 0
Andrea Grant
Address 56111 0
Orthopaedic Research Institute of Queensland.
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico 4812
Country 56111 0
Australia
Phone 56111 0
+61 747550564
Fax 56111 0
Email 56111 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 56112 0
Andrea Grant
Address 56112 0
Orthopaedic Research Institute of Queensland.
Suite 3 Level 2 Mater Medical Centre 21 - 29 Fulham Road Pimlico Queensland 4812
Country 56112 0
Australia
Phone 56112 0
+61 747550564
Fax 56112 0
Email 56112 0
research_coordinator@oriql.com.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

Documents added manually
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Documents added automatically
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