Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000364178
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
7/03/2019
Date last updated
7/03/2019
Date data sharing statement initially provided
7/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two techniques for pain relief following Knee Replacement Surgery
Scientific title
A Prospective, Randomised, Controlled Trial to Determine if the Addition of Intrathecal Morphine to Local Anaesthetic Infiltration Improves Analgesia and Patient Outcomes Following Primary, Unilateral Knee Replacement
Secondary ID [1] 297371 0
none
Universal Trial Number (UTN)
U1111-1228-3723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Replacement Surgery 311505 0
Condition category
Condition code
Anaesthesiology 310140 310140 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200 micrograms of intrathecal morphine administered immediately before knee replacement surgery. This is in addition to 3.0mL 0.5% plain bupivacaine and a propofol infusion intraoperatively for either sedation or general anaesthesia.
Intervention code [1] 313622 0
Treatment: Drugs
Comparator / control treatment
15 micrograms of intrathecal fentanyl administered immediately before knee replacement surgery. This is in addition to 3.0mL 0.5% plain bupivacaine and a propofol infusion intraoperatively for either sedation or general anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 319039 0
Pain Scores via numerical rating scale
Timepoint [1] 319039 0
maximum score in first 24hr post op (single measurement)
Primary outcome [2] 319040 0
Opioid Consumption as measured by oral morphine dose equivalents of administered opioid.
(on review as recorded in medical records)
Timepoint [2] 319040 0
at 24hr post op (single measurement)
Secondary outcome [1] 366776 0
Pain Scores using Numerical Rating Scale
Timepoint [1] 366776 0
maximum score in period 24-48hr post op (single measurement)
Secondary outcome [2] 366777 0
Opioid Consumption as measured by oral morphine dose equivalents of administered opioid
(on review as recorded in medical records)
Timepoint [2] 366777 0
total dose in period 24-48hr post op (single measurement)
Secondary outcome [3] 366778 0
Quality of Recovery vis QoR-15 score
Timepoint [3] 366778 0
Day 2 post op
Secondary outcome [4] 366779 0
KOOS Score
Timepoint [4] 366779 0
6 weeks post op
Secondary outcome [5] 366780 0
Maximal Knee Flexion/Extension,
Timepoint [5] 366780 0
at Day 2 post procedure and 6 weeks post op
Secondary outcome [6] 366781 0
Patient reported Nausea and Vomiting based on direct patient question as mild, moderate or severe
Timepoint [6] 366781 0
single assessment for time period 0-24hr post op and 24-48 hours post op
Secondary outcome [7] 366984 0
30 sec chair test
Timepoint [7] 366984 0
at Day 2 post procedure and 6 weeks post op
Secondary outcome [8] 366985 0
40m walk test
Timepoint [8] 366985 0
at Day 2 post procedure and 6 weeks post op
Secondary outcome [9] 366986 0
Stair climb test
Timepoint [9] 366986 0
at Day 2 post procedure and 6 weeks post op
Secondary outcome [10] 366987 0
Patient reported itch based on direct patient question as mild, moderate or severe
Timepoint [10] 366987 0
single assessment for time period 0-24hr post op and 24-48 hours post op
Secondary outcome [11] 366988 0
Hospital Stay from discharge summary
Timepoint [11] 366988 0
At time of hospital discharge

Eligibility
Key inclusion criteria
Elective primary unilateral total knee arthroplasty
Age 40-75 years
ASA 1-3
Ability to self mobilise
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI>40
Previous involvement in this study.
Neuropathic pain or opioid tolerance (defined as use of >30mg oral morphine/day or
equivalent – fentanyl patch 12mcg/hr, buprenorphine patch 20mcg/hr, oral oxycodone
>20mg/day)
History of stroke or major neurological deficit, sensory and motor disorders in the
operated limb
Contraindication to spinal anaesthesia (including coagulopathy, sepsis, local infection,
patient refusal, spinal defects, previous laminectomy, use of anticoagulant/antiplatelet
medications as per ASRA guidelines)
Contraindication to any of the study drugs (including allergy, significant renal or
hepatic disease, NSAID induced asthma)

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)
Sealed Opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Both groups will be analysed on an intention-to-treat basis

1. Opioid Usage, Pain scores, QoR-15 scores, KOOS scores, functional test results and hospital stay will be assessed as continuous variables

The effect of intrathecal morphine on continuous variables will be analysed by two tailed t- tests.The effect on changes in repeated measures will be analysed using repeated measures ANOVA. The effect of intrathecal morphine on categorical variables will be analysed by Chi-squared tests.

Statistical analysis appropriate to confirm test assumptions are met will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
28/02/2020
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13090 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 25600 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 301938 0
Hospital
Name [1] 301938 0
Friends of the Mater Grant
Country [1] 301938 0
Australia
Primary sponsor type
Hospital
Name
Mater and St Vincents Health
Address
The Mater Hospital,
Rocklands Rd, North Sydney
NSW. 2060
Country
Australia
Secondary sponsor category [1] 301693 0
None
Name [1] 301693 0
Address [1] 301693 0
Country [1] 301693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302620 0
St Vincent's Hospital Research office
Ethics committee address [1] 302620 0
Ethics committee country [1] 302620 0
Australia
Date submitted for ethics approval [1] 302620 0
19/10/2016
Approval date [1] 302620 0
03/11/2016
Ethics approval number [1] 302620 0
16/127

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

Contacts
Principal investigator
Name 90846 0
Dr Benjamin Olesnicky
Address 90846 0
c/- Dept of Anaesthesia,
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 90846 0
Australia
Phone 90846 0
+61 2 9463 2488
Fax 90846 0
Email 90846 0
[email protected]
Contact person for public queries
Name 90847 0
Benjamin Olesnicky
Address 90847 0
c/- Dept of Anaesthesia,
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 90847 0
Australia
Phone 90847 0
+61 2 9463 2488
Fax 90847 0
Email 90847 0
[email protected]
Contact person for scientific queries
Name 90848 0
Benjamin Olesnicky
Address 90848 0
c/- Dept of Anaesthesia,
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 90848 0
Australia
Phone 90848 0
+61 2 9463 2488
Fax 90848 0
Email 90848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan to make publicly avaialable


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.