Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000923763
Ethics application status
Approved
Date submitted
13/08/2013
Date registered
21/08/2013
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing blood levels of ketorolac ( Toradol) injected in around the hip and knee joints in patients undergoing joint replacements
Scientific title
Pharmacokinetic study of intraarticular and periarticular injection of ketorolac in patients undergoing total hip and knee replacements
Secondary ID [1] 283014 0
Nil known
Universal Trial Number (UTN)
U1111-1146-6793
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood levels of analgesics 289842 0
Condition category
Condition code
Anaesthesiology 290198 290198 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Studying the blood levels of ketorolac at 30 minutes, 1,2,4,8,24 hours after intraarticular infiltration during total hip and total knee replacements
Intervention code [1] 287729 0
Not applicable
Comparator / control treatment
No control arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290222 0
serum levels of ketorolac will be analysed using High-performance liquid chromatography (HPLC) at Biochemical laboratory, University of Queensland.
Timepoint [1] 290222 0
30 mins, 1,2,4,8 and 24 hours post infiltration
Secondary outcome [1] 304149 0
Postoperative day 1 routine blood tests: full blood count, serum urea, creatinine, electrolytes and glomerular filtration rate
Timepoint [1] 304149 0
first postoperative day

Eligibility
Key inclusion criteria
Should be able to speak and understand English
Should be able to give an informed consent
Patients > 18 yrs of age
Both Male and female patients undergoing Total Hip and Total Knee Replacements
All patients should have normal renal function
Participating patients should have no systemic diseases which include severe heart/lung conditions/bleeding disorders
Not on any medications which could alter renal function
Patients will not receive any further NSAID’s in the first 24 hrs of surgery
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients < 18 yrs of age
Consent not obtained
Impaired renal function
Patients with severe cardiovascular / lung diseases
Pregnancy/lactation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
The concentration of Ketorolac will be determined by chromatographic methods that are validated and conducted in accordance with the FDA’s guidance for industry on bioanalysis.
The concentration results will be submitted for pharmacokinetic and statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
24/10/2013
Date of last participant enrolment
Anticipated
30/09/2013
Actual
11/12/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1439 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7270 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 287777 0
Government body
Name [1] 287777 0
Queensland University of Technology
Country [1] 287777 0
Australia
Primary sponsor type
Individual
Name
Dr.Usha Gurunathan
Address
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country
Australia
Secondary sponsor category [1] 286504 0
None
Name [1] 286504 0
Address [1] 286504 0
Country [1] 286504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289727 0
HREC at the Prince Charles Hospital
Ethics committee address [1] 289727 0
Rode Road, Chermside, QLD 4032
Ethics committee country [1] 289727 0
Australia
Date submitted for ethics approval [1] 289727 0
Approval date [1] 289727 0
05/11/2012
Ethics approval number [1] 289727 0
HREC/12/QPCH/147

Summary
Brief summary
Participating patients will be screened as per the study protocol and will have prior informed consent.
Ten patients with normal renal function undergoing total knee or hip replacement surgeries are chosen for the study. As per the usual procedure in the hospital, surgeon infiltrates the joint with 100ml of 0.2% ropivacaine with adrenaline along with 30mg ketorolac at the end of surgery. Serial blood samples are taken at 30 mins, 1,2,4,8 and 24 hours post infiltration. Serum concentrations of ketorolac will be analysed using HPLC at Biochemical lab, University of Queensland. The results will be analysed by the research team.
Trial website
NIL
Trial related presentations / publications
NIL so far
Public notes

Contacts
Principal investigator
Name 42134 0
Dr Usha Gurunathan
Address 42134 0
Department of Anaesthesia & Perfusion services, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 42134 0
Australia
Phone 42134 0
+ 61 7 3139 4000
Fax 42134 0
Email 42134 0
[email protected]
Contact person for public queries
Name 42135 0
Dr Usha Gurunathan
Address 42135 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 42135 0
Australia
Phone 42135 0
+61 7 3139 4000
Fax 42135 0
Email 42135 0
[email protected]
Contact person for scientific queries
Name 42136 0
Dr Usha Gurunathan
Address 42136 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 42136 0
Australia
Phone 42136 0
+61 7 3139 4000
Fax 42136 0
Email 42136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
There may not be much clinical utility to the public with their individual blood results data. As far as other researchers are concerned, study data can be available at investigator's discretion.


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
EmbasePopulation Pharmacokinetics of Periarticular Ketorolac in Adult Patients Undergoing Total Hip or Total Knee Replacement Surgery.2019https://dx.doi.org/10.1213/ANE.0000000000003377
N.B. These documents automatically identified may not have been verified by the study sponsor.