Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000488505
Ethics application status
Approved
Date submitted
5/05/2015
Date registered
18/05/2015
Date last updated
18/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient function & pain control after total knee replacement:
Is it improved by use of peri-articular or intra-articular infiltration ?
Scientific title
Comparison of postoperative pain control in patients receiving total knee replacement, using either periarticular or intraarticular local infiltration analgesia.
Secondary ID [1] 286634 0
nil
Universal Trial Number (UTN)
U1111-1169-8414
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain following total knee replacement surgery 294957 0
Condition category
Condition code
Surgery 295217 295217 0 0
Surgical techniques
Anaesthesiology 295218 295218 0 0
Pain management
Musculoskeletal 295298 295298 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred and forty two consecutive patients undergoing total knee arthroplasty were enrolled. Patients were divided into 2 groups, a periarticular infiltration group (Group A) and an intraarticular injection group (Group B). Both groups received the same infiltrate – a combination of 30mg ketorolac, 500mcg of adrenaline, and 300mg of ropivacaine, and normal saline.

In Group A patients, the 150mL was infiltrated after implantation of the prosthesis, prior to insertion of the polyethylene liner. Of this, 50mL was infiltrated into the posterior capsule and intercondylar area; 50mL was infiltrated into the anterior capsule, the collateral ligaments and along the femur and tibia; and the remaining 50mL was infiltrated into subcutaneous tissue following closure of the capsule.

Group B patients had all of the 150ml injected intraarticularly after closure of the wound.
Intervention code [1] 291776 0
Treatment: Surgery
Intervention code [2] 291839 0
Treatment: Drugs
Comparator / control treatment
Active control
Both techniques (periarticular and/or intraarticular injection) are considered standard treatments.
Control group
Active

Outcomes
Primary outcome [1] 294970 0
opioid consumption, assessed by patient medical charts and converted into standardised morphine equivalents.
Timepoint [1] 294970 0
during first 24 hrs postoperative
Primary outcome [2] 294971 0
opioid consumption, assessed by patient medical charts and converted into standardised morphine equivalents.
Timepoint [2] 294971 0
over total inpatient admission
Primary outcome [3] 294972 0
postoperative pain using a visual analogue scale
Timepoint [3] 294972 0
during postoperative day 1 and at discharge
Secondary outcome [1] 314486 0
oxford knee score
Timepoint [1] 314486 0
6 weeks postoperatively
Secondary outcome [2] 314487 0
knee flexion as assessed by doctor or physiotherapist on physical examination (no goniometer used)
Timepoint [2] 314487 0
at discharge, and at 6 weeks postoperatively
Secondary outcome [3] 314488 0
length of stay
Timepoint [3] 314488 0
from time of admission to hospital discharge.
Secondary outcome [4] 314489 0
haemoglobin drop, based on difference from routine preadmission preoperative blood test measurement to day 1 postoperative haemoglobin blood test measurement.
Timepoint [4] 314489 0
postoperative day 1

Eligibility
Key inclusion criteria
adult patients waitlisted for primary total knee replacement for osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergy or intolerance to study drugs, known inability to receive spinal anaesthesia, and planned bilateral knee surgery.

secondary exclusion criteria: history of regular opioid use, concurrent psychiatric illness, serious medical comorbidities that might prolong hospital admission, and coagulation disorders

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)
The patients were enrolled from the outpatient clinic in a consecutive manner into 2 groups. The first 71 patients were enrolled into the periarticular infiltration group, and the following 71 patients were enrolled into the intraarticular injection arm. The patients were blinded as to their intervention (periarticular infiltration or intraarticular injection)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patients were not randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
The patients were enrolled from the outpatient clinic in a consecutive manner into 2 groups. The first 71 patients were enrolled into the periarticular infiltration group, and the following 71 patients were enrolled into the intraarticular injection arm. The patients were blinded as to their intervention (periarticular infiltration or intraarticular injection)
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis Demographic variables for participants will be described as using mean and standard deviation (SD) for continuous variables or frequencies and percentages for categorical variables. Trends over time in response variables will be analysed using standard regression models, and used to compare pre-treatment to the treatment period, but adjusting for the multiple assessments on each participant as a ‘random effect’ (ANOVA for repeated measures). Data analysed by intention-to-treat basis. A sample size of 142 (71 participants in each group) would be sufficient for a power of 0.8, with an alpha level of 0.05 and expecting a medium effect size of 0.25.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
5/10/2009
Date of last participant enrolment
Anticipated
1/01/2011
Actual
10/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3748 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 9628 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 291209 0
Self funded/Unfunded
Name [1] 291209 0
Country [1] 291209 0
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Orthopaedic Department
Fremantle Hospital
Alma St
Fremantle 6160
WA
Country
Australia
Secondary sponsor category [1] 289888 0
Individual
Name [1] 289888 0
michael perret
Address [1] 289888 0
Orthopaedic dept
Fremantle Hospital
Alma st
Fremantle WA 6160
Country [1] 289888 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292773 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 292773 0
Ethics committee country [1] 292773 0
Australia
Date submitted for ethics approval [1] 292773 0
Approval date [1] 292773 0
20/05/2009
Ethics approval number [1] 292773 0
09/186

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

Contacts
Principal investigator
Name 56954 0
Dr Michael Perret
Address 56954 0
Orthopaedic Dept
Fremantle Hospital
Alma St
Fremantle 6160
WA
Country 56954 0
Australia
Phone 56954 0
+61894313333
Fax 56954 0
Email 56954 0
[email protected]
Contact person for public queries
Name 56955 0
Michael Perret
Address 56955 0
Orthopaedic Dept
Fremantle Hospital
Alma St
Fremantle 6160
WA
Country 56955 0
Australia
Phone 56955 0
+61894313333
Fax 56955 0
Email 56955 0
[email protected]
Contact person for scientific queries
Name 56956 0
Michael Perret
Address 56956 0
Orthopaedic Dept
Fremantle Hospital
Alma St
Fremantle 6160
WA
Country 56956 0
Australia
Phone 56956 0
+61894313333
Fax 56956 0
Email 56956 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.