Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000196741
Ethics application status
Approved
Date submitted
30/01/2022
Date registered
4/02/2022
Date last updated
4/08/2022
Date data sharing statement initially provided
4/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
VOLT Study: Intraosseous Regional Administration of Voltaren™ in Primary Total Knee Arthroplasty
Scientific title
VOLT Study: Intraosseous Regional Administration of Voltaren™ in Primary Total Knee Arthroplasty . A Prospective, Double-Blinded, Randomised Controlled Trial Comparing the Analgesic Efficacy of Intraosseous Regional Diclofenac and Intravenous Diclofenac for Postoperative Pain Management in TKA
Secondary ID [1] 305635 0
None
Universal Trial Number (UTN)
Trial acronym
VOLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 324062 0
Acute pain 324063 0
Condition category
Condition code
Musculoskeletal 321575 321575 0 0
Osteoarthritis
Anaesthesiology 321576 321576 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Pre-operative single dose 75mg Diclofenac via intraosseous regional administration. The study medication will be prepared by an unblinded researcher, then administered by the study surgeon performing the surgery after tourniquet inflation.
Intervention code [1] 322032 0
Treatment: Drugs
Comparator / control treatment
Pre-operative single dose systemic (intravenous infusion) administration of Diclofenac 75mg. This will be administered by a blinded anaesthetist.
Control group
Active

Outcomes
Primary outcome [1] 329343 0
mean pain scores, as assessed by 100mm visual analogue scale
Timepoint [1] 329343 0
1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 12 hours, 24 hours post-op. In addition to twice daily measures at 8am and 5pm from post-op day 1 to post-op day 7
Secondary outcome [1] 402205 0
Mean daily morphine milligram equivalent (MME), converted from daily amounts of additional opioid medication (in mg) taken by patients. Patients will be required to note down the total amount in milligrams of opioids they are taking daily in a Study Participant Pain Diary (e.g. Sevredol 20 mg). Nurses will help patients and educate them on how to do this during their inpatient stay so that they are able to do this independently after discharge. The MME will be calculated from the medication recorded in the diary by researchers once the Pain Diary is handed in at the follow up clinic appointment.
Timepoint [1] 402205 0
7 days post-op. Daily amounts of opioid medication will be recorded and converted to MME
Secondary outcome [2] 402206 0
"knee health" as assessed by KOOS, Jr score
Timepoint [2] 402206 0
At follow up clinics at 2 weeks post-op and 6 weeks post-op
Secondary outcome [3] 404233 0
Quality of recovery (QoR-15) survey after anaesthesia, which is important in determining early postoperative health status of patients
Timepoint [3] 404233 0
To be completed at post-op day 1
Secondary outcome [4] 404234 0
How pain has affected the patient’s walking ability/gait over the past 24 hours, as judged by daily numerical rating scale recordings
Timepoint [4] 404234 0
Daily recording of score on numerical rating scale up to post-op day 7
Secondary outcome [5] 404235 0
How pain has affected the patient’s sleep quality over the past 24 hours, as judged by daily numerical rating scale recordings
Timepoint [5] 404235 0
Daily recording of score on numerical rating scale up to post-op day 7
Secondary outcome [6] 404236 0
Average length of hospital stay for patients. Date of admission and date of discharge will be noted on the Study Participant Pain Diary by patients or nursing staff. This can also be correlated with the dates on each participant's discharge summary. Average length of hospital stay will be calculated for each study group using these dates.
Timepoint [6] 404236 0
Measured from date of admission/operation to date of discharge
Secondary outcome [7] 404237 0
Patient overall satisfaction of their total knee joint replacement, as measured by numerical rating scale
Timepoint [7] 404237 0
Numerical rating scale scores to be recorded at 2 weeks and 6 weeks post-op at follow up clinics
Secondary outcome [8] 404238 0
Oxford knee score - a questionnaire designed for patients undergoing total knee replacement. Relates to an individual’s level of function, activities of daily living, and how they have been affected by pain, over the past 4 weeks
Timepoint [8] 404238 0
At week 6 post-op follow up clinic

Eligibility
Key inclusion criteria
Informed consent obtained - both written and verbal
Primary total knee arthroplasty for Osteoarthritis
Age greater then or equal to 18 and less than or equal to 80
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient lacking capacity to consent to the research project
BMI greater than or equal to 40
Pregnancy or suspected pregnancy
Pain Catastrophising Scale score greater than or equal to 30 points
Previous infection of knee joint
Rheumatoid/inflammatory arthritis
Undergoing bilateral total knee replacement, revision total knee arthroplasty, or any additional procedure outside of a primary total knee arthroplasty
Precluded from having general anaesthesia
Patients with lower limbs not amenable to effective tourniquet use

Contraindications to Diclofenac:
Known allergy or hypersensitivity to Aspirin or other NSAID - including attacks of asthma, angioedema, urticaria, or acute rhinitis
Severe renal disease (GFR<15 mL/min/1.73m2)
Severe cardiac failure
Hepatic failure
Active gastric or intestinal ulcer, bleeding or perforation
Recent myocardial infarction (within last 12 months)
History of asthma
History of haemorrhagic diathesis

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 - computerised sequence generation (random number generator), in 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was calculated by a consulting statistician, such that 46 patients should be adequate to achieve 95% power in the study to detect a minimal clinically important difference of 20mm on VAS pain scale.

Statistical analysis of the primary outcome data will be completed using a general linear model or generalised linear mixed model, followed by independent two-sample t-test or Wilcoxon non-parametric rank sum test. For secondary objectives, independent two-sample t-test or Wilcoxon non-parametric rank sum test will be used. The intended statistical test used will be dependent on the distribution of the data collected. This will be determined by appropriate normality and homogeneity testing of the data. If requirements are not met, a transformation may be applied, which will likely be logarithmic. Adjustments will be made accordingly based on the data obtained

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/07/2022
Actual
3/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 24245 0
New Zealand
State/province [1] 24245 0
Auckland

Funding & Sponsors
Funding source category [1] 309995 0
Charities/Societies/Foundations
Name [1] 309995 0
The Wishbone Orthopaedic Research Foundation
Country [1] 309995 0
New Zealand
Primary sponsor type
Individual
Name
Simon Young
Address
Southern Cross Hospital North Harbour
232 Wairau Road
Glen field
Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 311198 0
None
Name [1] 311198 0
N/A
Address [1] 311198 0
N/A
Country [1] 311198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309704 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 309704 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309704 0
New Zealand
Date submitted for ethics approval [1] 309704 0
25/01/2022
Approval date [1] 309704 0
11/03/2022
Ethics approval number [1] 309704 0

Summary
Brief summary
The aim of this study is to evaluate the effectiveness of intraosseous Diclofenac (Voltaren™) compared to systemic (intravenous) Diclofenac, in managing postoperative pain for total knee joint replacements. The overarching goal is to determine an effective method of providing postoperative pain relief so patients may recover better from their surgery and have better outcomes from their knee replacements.

Intraosseous regional administration (IORA) of analgesia is a novel technique being used in New Zealand and overseas with anecdotal evidence for improved post-operative pain management following total knee joint replacements. This method involves directly injecting the study medication into the shin bone (directly into bone marrow) after inflating a tourniquet around the thigh to keep medication localised in the surgical area. This should result in greater concentrations of Diclofenac achieved in the soft tissue around the surgical site both after tourniquet inflation and after tourniquet deflation, resulting in prolonged analgesia. By-products of this effect should also include reduced systemic concentrations of the medication (leading to reduced systemic side effects of the medication), a reduction in need for rescue analgesia including opioids (which come with their own side effects), as well as improved overall postoperative outcomes for patients with better recovery following their surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115102 0
Mr Simon Young
Address 115102 0
Southern Cross Hospital North Harbour
232 Wairau Road
Glenfield
Auckland 0627
Country 115102 0
New Zealand
Phone 115102 0
+6421616183
Fax 115102 0
Email 115102 0
simon.young@auckland.ac.nz
Contact person for public queries
Name 115103 0
Mr Simon Young
Address 115103 0
Southern Cross Hospital North Harbour
232 Wairau Road
Glenfield
Auckland 0627
Country 115103 0
New Zealand
Phone 115103 0
+6499254400
Fax 115103 0
Email 115103 0
simon.young@auckland.ac.nz
Contact person for scientific queries
Name 115104 0
Mr Simon Young
Address 115104 0
Southern Cross Hospital North Harbour
232 Wairau Road
Glenfield
Auckland 0627
Country 115104 0
New Zealand
Phone 115104 0
+6499254400
Fax 115104 0
Email 115104 0
simon.young@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not the intention of the research team


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13734Study protocol    Study protocol 383011-(Uploaded-22-01-2022-15-18-03)-Study-related document.pdf
13736Informed consent form    Study patient information sheet and informed conse... [More Details] 383011-(Uploaded-22-01-2022-15-22-00)-Study-related document.pdf
13738Other    Data Management Plan 383011-(Uploaded-22-01-2022-15-24-53)-Study-related document.pdf
14757Other    Patient Outcome Forms - Combined 383011-(Uploaded-22-01-2022-15-27-30)-Study-related document.pdf
14758Other    Study Participant Pain Diary 383011-(Uploaded-22-01-2022-15-30-09)-Study-related document.pdf
14759Other    Study scientific peer review + letter signed 383011-(Uploaded-22-01-2022-16-05-15)-Study-related document.pdf
16543Ethical approval    383011-(Uploaded-11-03-2022-21-55-22)-Study-related document.pdf



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.