Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000406202
Ethics application status
Approved
Date submitted
18/05/2009
Date registered
2/06/2009
Date last updated
2/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving pain relief following Total Knee Replacement
Scientific title
The effect of Continuous Femoral Nerve Infusion versus Conventional Analgesia on pain levels following Total Knee Arthroplasty: A prospective randomised, double blind, placebo controlled Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following total knee replacement 4795 0
Condition category
Condition code
Musculoskeletal 237140 237140 0 0
Other muscular and skeletal disorders
Surgery 237241 237241 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the treatment arm of the study will have a femoral nerve infusion of Bupivicaine 0.125% running at 10ml/hr for 48 hours after total knee replacement while the placebo will have saline running for 48 hours.
all patients will have an intraoperative femoral nerve injection of 15ml Bupivicaine 0.25% along with subarachnoid blockade using 10-20mcg 0.5% bupivicaine + 3mcg/kg Morphine.
Sedation using Midazolam/Propofol titrated to effect or General Anaesthetic (GA)
Intervention code [1] 4569 0
Treatment: Surgery
Intervention code [2] 4570 0
Treatment: Drugs
Comparator / control treatment
saline running into femoral nerve catheter rather than local anaesthetic for 48 hours
Control group
Placebo

Outcomes
Primary outcome [1] 237959 0
pain at rest (visual analogue scale)
Timepoint [1] 237959 0
from day 1 post operation for next 72 hours, , measured every 8 hours
Secondary outcome [1] 242062 0
nerve infusion rate using information from infusion pump and bedside chart
Timepoint [1] 242062 0
up to 72 hours following operation
Secondary outcome [2] 242063 0
cumulative dose of narcotics calculated using infusion pump information
Timepoint [2] 242063 0
up to 72 hours following operation

Eligibility
Key inclusion criteria
18-85 years
Body Mass Index (BMI) less than 40
undergoing primary total knee replacement
ability to give informed consent
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI greater than 40
older than 85
contraindication to femoral nerve catheter
major medical comorbidity

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)
enrolling at preoperative assessment
allocated to treatment or non treatment arm postoperatively in recovery
allocation concealed by sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1776 0
New Zealand
State/province [1] 1776 0

Funding & Sponsors
Funding source category [1] 4965 0
University
Name [1] 4965 0
richard stewart scholarship
university of otago
Country [1] 4965 0
New Zealand
Primary sponsor type
Individual
Name
jean-claude theis
Address
department of orthopaedics
dunedin hospital
201 great king st
dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 4490 0
Individual
Name [1] 4490 0
jason locker
Address [1] 4490 0
340 portobello road
challis point
dunedin
RD2 9077
Country [1] 4490 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7069 0
lower south regional ethics committee
Ethics committee address [1] 7069 0
ministry of health
229 moray place
po box 5849
dunedin
no postcode but courier address:
c/o ministry of health
229 moray place
dunedin
Ethics committee country [1] 7069 0
New Zealand
Date submitted for ethics approval [1] 7069 0
Approval date [1] 7069 0
12/02/2009
Ethics approval number [1] 7069 0

Summary
Brief summary
Studies have shown that femoral nerve infusions post total knee replacement may improve pain relief but a double blind, placebo controlled trial has not been conducted.
Null hypothesis is that a continuous infusion of local anaesthetic for 48 hours post operation makes no difference to pain levels
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29612 0
Address 29612 0
Country 29612 0
Phone 29612 0
Fax 29612 0
Email 29612 0
Contact person for public queries
Name 12859 0
jason locker
Address 12859 0
department of orthopaedics
dunedin hospital
201 great king street
dunedin 9013
Country 12859 0
New Zealand
Phone 12859 0
+64 3 474 0999 pager 6944
Fax 12859 0
Email 12859 0
jason.locker@otagodhb.govt.nz
Contact person for scientific queries
Name 3787 0
jason locker
Address 3787 0
department of orthopaedics
dunedin hospital
201 great king street
dunedin 9013
Country 3787 0
New Zealand
Phone 3787 0
+64 3 474 0999 pager 6944
Fax 3787 0
Email 3787 0
jason.locker@otagodhb.govt.nz

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
SourceTitleYear of PublicationDOI
EmbaseFemoral nerve infusion after primary total knee arthroplasty: A prospective, double-blind, randomised and placebo-controlled trial.2015https://dx.doi.org/10.1302/2046-3758.42.2000329
N.B. These documents automatically identified may not have been verified by the study sponsor.