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Trial registered on ANZCTR


Registration number
ACTRN12615000719538
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
10/07/2015
Date last updated
10/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does injection of local anaesthetic into the joint after total knee replacement affect range of motion?
Scientific title
Does instillation of periarticular local anaesthetic after total knee replacement affect range of motion: A Randomized Control Trial
Secondary ID [1] 287015 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee range of motion following total knee replacement 295482 0
Osteoarthritis 295524 0
Condition category
Condition code
Surgery 295736 295736 0 0
Other surgery
Anaesthesiology 295737 295737 0 0
Pain management
Musculoskeletal 295801 295801 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our intervention will be the surgeon’s standard practice of 200mg of naropin (ropivacaine) and 0.5mg of adrenaline, used as local infiltration analgesia injected around the joint replacement in TKA.
Intervention code [1] 292222 0
Treatment: Drugs
Comparator / control treatment
The control knee which will be the knee (left or right) injected with 100ml of normal saline.
Control group
Placebo

Outcomes
Primary outcome [1] 295451 0
The primary outcome is to determine whether local infiltration analgesia in bilateral TKA leads to a reduction in range of knee flexion in bilateral TKA.

Timepoint [1] 295451 0
Range of knee flexion will be measured using a goniometer at baseline (pre-operation) and at 6 weeks post operation.
Secondary outcome [1] 315603 0
To determine whether local infiltration analgesia increases manipulation under anaesthesia (MUA) rates
Timepoint [1] 315603 0
At 6 weeks post operation, knee flexion is measured using a goniometer. If knee flexion is reduced below 90 degrees, patients undergo MUA to increase the knee ROM and flexion usually 8-10 weeks post operation.

We will use a chi square test in order to determine whether there is a significant difference between incidence of manipulation under anaesthesia rates between the groups.
Secondary outcome [2] 315604 0
To determine whether periarticular local analgesia improves post operative pain in the first 48 hours.
Timepoint [2] 315604 0
A 100mm visual analogue scale (VAS) will be used to asse pain scores at 8, 24 and 48 hours after surgery.

Eligibility
Key inclusion criteria
All patients with a diagnosis of osteoarthritis undergoing bilateral total knee arthoplasty
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with allergies to any of the used analgesic agents, patients unable to undergo a femoral sheath or sciatic nerve block. Patient’s with prior surgeries on their knee, for example prior knee arthroscopies, high tibial osteotomy, tibial or femoral nail, open reduction and internal fixation of the distal femur will all be excluded from the study. Patients with either a varus or valgus knee deformity were excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291568 0
Self funded/Unfunded
Name [1] 291568 0
Country [1] 291568 0
Primary sponsor type
Individual
Name
Michael Hunter
Address
Gosford Hospital, Holden Road, Gosford, NSW 2250
Country
Australia
Secondary sponsor category [1] 290242 0
None
Name [1] 290242 0
Address [1] 290242 0
Country [1] 290242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293107 0
NSLHD HREC
Ethics committee address [1] 293107 0
Ethics committee country [1] 293107 0
Date submitted for ethics approval [1] 293107 0
Approval date [1] 293107 0
25/02/2015
Ethics approval number [1] 293107 0
HREC/14/HAWKE/418

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

Contacts
Principal investigator
Name 58302 0
Dr Michael Hunter
Address 58302 0
Gosford Hospital, Holden street, Gosford, NSW 2250
Country 58302 0
Australia
Phone 58302 0
+61 2 43202111
Fax 58302 0
Email 58302 0
claudetteandmichael@hotmail.com
Contact person for public queries
Name 58303 0
Antony Nguyen
Address 58303 0
Concord Hospital, Hospital Road, Concord, NSW 2139
Country 58303 0
Australia
Phone 58303 0
+61 2 97675000
Fax 58303 0
Email 58303 0
antony_nguyen@hotmail.com
Contact person for scientific queries
Name 58304 0
Antony Nguyen
Address 58304 0
Concord Hospital, Hospital Road, Concord, NSW 2139
Country 58304 0
Australia
Phone 58304 0
+61 2 97675000
Fax 58304 0
Email 58304 0
antony_nguyen@hotmail.com

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.