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Trial registered on ANZCTR


Registration number
ACTRN12612000343808
Ethics application status
Not yet submitted
Date submitted
22/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes following a Multimodal Pain Protocol in Total Knee Arthroplasty
Scientific title
A retrospective/prospective study of patients who had undergone total knee arthroplasty during 2011 and 2012 with a specific pain protocol, analysing outcomes in the post operative period.
Secondary ID [1] 280130 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty post operative pain and mobility 286058 0
Condition category
Condition code
Surgery 286251 286251 0 0
Other surgery
Musculoskeletal 286345 286345 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be divided into 2 main cohorts for study purposes.

The first cohort will be a retrospective review of all total knee replacements performed within the last year (2011) at Cairns Base Hospital. It is hoped to recruit approximately 100-150 participants into this study. This cohort will not adhere to our multi-modal analgesic pathway.
There will therefore be a wide array of anaesthesic modalities ranging from central catheter techniques such as spinals, epidurals, combined spinal-epidurals (CSE), to general anaesthesia (GA), to peripherally placed catheters such as femoral nerve blocks (FNB) or fascia iliaca blocks (FIB) applied to this cohort of patients.

The second cohort of participants will be a prospective review of all total knee replacements performed at Cairns Base Hospital from the date of ethics approval onwards for however long it is required to recruit approximately 100-150 participants into this cohort.

The second cohort of patients will strictly adhere to the multi-modal analgesic pathway described below.
Participants will have either a GA or single shot spinal anaesthetic given at the discretion of the anaesthetist. Participants will also receive a single shot femoral nerve block prior to commencement of surgery while in the induction bay administered by the anaesthetist. During the surgery, the surgeon will inject local anaesthetic (Bupivocaine 0.2%/Ropivocaine 0.5% - 100ml) into the posterior capsule of the knee prior to commencement of cementing the knee.

A Total Knee Arthroplasty is a lengthy procedure with complicated steps lasting approximately an hour and a half to 2 hours depending on surgeon skill, instrumentation and deformity of the knee.

After the patient has been anaesthetized, the patient will be prepped & draped, after which a midline parapatella approach is performed down to the knee joint. Osteophytes will be removed and the patella subluxated laterall to allow full access to the femur and tibia. The ACL is dissected out, and the osteoarthritic portions of the distal femur and proximal tibia will be resected. Specific jigs/guides will be utilised to allow for correction of varus/valgus or rotational deformity of the knee and to shape the femur and tibia to receive the definitive implants.

Trial implants will be inserted first to determine if any further correction is required before the definitive implants are placed. If adequate, the knee joint is thoroughly washed and depending on the implants utilised, cement may be used to hold the femoral component in place or there may be a specific hydroxyapatite coating on the femoral component allowing bony ingrowth. The tibial component is always cemented in place. A highly cross-linked polyethylene insert is then placed between the femoral and tibial components to allow gliding of the implants.

The knee is then washed again, and the retinaculum repaired over the knee joint, the wound closed in layers and a dressing placed over the wound.

Patient’s will then be placed on a Patient Controlled Analgesia (PCA) overnight and be reviewed by the Acute Pain Team/Service in the morning.

Formal bloods and x-rays will be ordered and participants will be visited by the physiotherapist during the day. Mobility will be determined by whether patient achieved transfer from bed – chair whether with minimal/heavy assistance, and whether patient was able to mobilise with aid of a frame/rollator with guidance from the physiotherapist.
Intervention code [1] 284467 0
Treatment: Surgery
Comparator / control treatment
The control group will be a retrospective review of all patients who have undergone total knee arthroplasty at Cairns Base Hospital from 2011, however, no specific pain protocol will be adhered to.
Control group
Historical

Outcomes
Primary outcome [1] 286718 0
Quadriceps weakness and mobility day 1 post operatively.

This is assessed by the physiotherapist who visit the patient's everyday, specifically on day 1 post operative.

Quads weakness is assessed from a grade of 1-5, where 1 has not even a flicker of muscle movement through to 5 where there is normal power and movement against resistance and gravity.

Mobility will be assessed as to whether the patient can complete exercises provided by the physiotherapist in bed, then progress onto the transfer from bed to standing, and finally mobilization with aid of a forearm support frame/4 wheel walker/Hopper frame.
Timepoint [1] 286718 0
Day 1 post op
Secondary outcome [1] 296526 0
Pain scores - mild, moderate or severe. These will be recorded by the Acute Pain Service who will review the patient day 1 post op.
Timepoint [1] 296526 0
From day 1 post op until discharge
Secondary outcome [2] 296705 0
Complications - these will be recorded in the patient's charts
Timepoint [2] 296705 0
From day 1 post op until discharge
Secondary outcome [3] 296706 0
Length of stay - how many days the patient is required to stay in hospital from day 1 post op till discharge.
Timepoint [3] 296706 0
From day 1 post op until discharge

Eligibility
Key inclusion criteria
Unilateral total knee arthroplasty at Cairns Base Hospital using the specific pain protocol (GA/spinal + FNB + posterior capsule infiltration)
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients not providing informed consent.
- Refusal of treatment plan.
- Preexisting medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
- Revision total knee arthroplasty.
- Known allergy to any of the medications being used.
- History of drug or alcohol abuse.
- Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day.
- Patients with Rheumatoid Arthritis.
- Patients with psychiatric disorders.
- Patients unable or unwilling to use Patient Controlled Analgesia.
- Obese patients (i.e. BMI >45).
- Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual rehabilitation protocol of care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A prospective review of all total knee replacements performed at Cairns Base Hospital from the date of ethics approval onwards for however long it is required to recruit approximately 100-150 patients into this cohort.

Participants will be mailed out an Invitation to Participate letter along with a Participant Information Consent form if retrospectively followed, if prospectively followed will receive the above forms whilst an inpatient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284886 0
Self funded/Unfunded
Name [1] 284886 0
Country [1] 284886 0
Primary sponsor type
Individual
Name
Dr Gerald Yeo
Address
Unit 214
12 Gregory Street
Westcourt
QLD 4870
Country
Australia
Secondary sponsor category [1] 283766 0
Individual
Name [1] 283766 0
Ms Julie Cappello
Address [1] 283766 0
Unit 120
22 Ward Street
Mooroobool
QLD 4870
Country [1] 283766 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286883 0
Ethics committee address [1] 286883 0
Ethics committee country [1] 286883 0
Date submitted for ethics approval [1] 286883 0
18/04/2012
Approval date [1] 286883 0
Ethics approval number [1] 286883 0

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

Contacts
Principal investigator
Name 33917 0
Address 33917 0
Country 33917 0
Phone 33917 0
Fax 33917 0
Email 33917 0
Contact person for public queries
Name 17164 0
Dr Gerald Yeo
Address 17164 0
Orthopaedic Surgery
First Floor, Block B
Cairns Base Hospital (The Esplanade)
Cairns
QLD, 4870
Country 17164 0
Australia
Phone 17164 0
+61409931854
Fax 17164 0
Email 17164 0
dr.geraldyeo@gmail.com
Contact person for scientific queries
Name 8092 0
Dr Gerald Yeo
Address 8092 0
Orthopaedic Surgery
First Floor, Block B
Cairns Base Hospital (The Esplanade)
Cairns
QLD, 4870
Country 8092 0
Australia
Phone 8092 0
+61409931854
Fax 8092 0
Email 8092 0
dr.geraldyeo@gmail.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.