Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000911493
Ethics application status
Approved
Date submitted
24/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
TAPentadol vs OxycodoNe on the incidence of persistent opioid use after hip or knee arthroplasty (TAP-ON Study)
Scientific title
TAPentadol vs OxycodoNe on the incidence of persistent opioid use after hip or knee arthroplasty: A pilot feasibility study (TAP-ON Pilot Study)
Secondary ID [1] 313901 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TAP-ON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 336588 0
Condition category
Condition code
Surgery 333096 333096 0 0
Other surgery
Anaesthesiology 334701 334701 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised controlled pilot study.
The intervention arm will be tapentadol immediate release (IR) oral plus usual care post total hip or knee arthroplasty once patient is tolerating oral medications. Tapentadol will be used as needed for pain.
Dosage and duration will be guided by the product information and adjusted according to individual pain response and clinical judgement. Maximum dose is 600mg in 24 hours. During admission, nursing staff will administer medications for patients. Usual care will be determined by each individual hospital processes, but may include paracetamol and non-steroidal anti-inflammatory medications.
Intervention code [1] 331443 0
Treatment: Drugs
Comparator / control treatment
The control arm will be oxycodone immediate release (IR) oral plus usual care post total hip or knee arthroplasty once patient is tolerating oral medications. Oxycodone will be used as needed for pain.
Dosage and duration will be guided by the product information and Therapeutic Guidelines and adjusted according to individual pain response and clinical judgement. Maximum dose is 120mg in 24 hours.
During admission, nursing staff will administer medications for patients. Usual care will be determined by each individual hospital processes, but may include paracetamol and non-steroidal anti-inflammatory medications.
Control group
Active

Outcomes
Primary outcome [1] 342087 0
A primary feasibility outcome is to determine the compliance rates of medications of interest without switching.
Timepoint [1] 342087 0
At follow up (3 months post surgery)
Primary outcome [2] 342366 0
A primary feasibility outcome is to determine the recruitment rate of eligible patients per month
Timepoint [2] 342366 0
At trial conclusion
Primary outcome [3] 342367 0
A primary feasibility outcome is to determine retention rate of participants in each group
Timepoint [3] 342367 0
At trial conclusion
Secondary outcome [1] 449554 0
A secondary objectives of the study is persistent opioid use
Timepoint [1] 449554 0
3 months after surgery
Secondary outcome [2] 450536 0
A secondary objective of the study is opioid-related adverse events
Timepoint [2] 450536 0
1-3 days postoperative and 3 months after surgery
Secondary outcome [3] 450538 0
Pain, stiffness and function
Timepoint [3] 450538 0
At baseline and 3 months after surgery
Secondary outcome [4] 450539 0
Non-opioid analgesic use
Timepoint [4] 450539 0
Baseline, 1-3 days post-surgery and 3 months post-surgery
Secondary outcome [5] 450541 0
Opioid use
Timepoint [5] 450541 0
Baseline, 1-3 days postoperative and 3 months after surgery
Secondary outcome [6] 450542 0
Pain intensity
Timepoint [6] 450542 0
1-3 days postoperative and 3 months after surgery
Secondary outcome [7] 450543 0
Surgical complications
Timepoint [7] 450543 0
1-3 days postoperative
Secondary outcome [8] 450544 0
Hospital readmission
Timepoint [8] 450544 0
30 days post surgery and 90 days post surgery
Secondary outcome [9] 451036 0
Pain Intensity
Timepoint [9] 451036 0
1-3 days postoperative and 3 months after surgery
Secondary outcome [10] 451037 0
Pain Intensity
Timepoint [10] 451037 0
1-3 days postoperative and 3 months after surgery
Secondary outcome [11] 451060 0
Benzodiazepine use
Timepoint [11] 451060 0
Baseline, 1-3 days postoperative and 3 months after surgery

Eligibility
Key inclusion criteria
Aged 18 years or older, is planned to receive elective unilateral or bilateral total hip or knee arthroplasty, speaks and reads English and has access to internet or a telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned repeat surgeries (same procedure within 6 months), major cognitive impairment, using opioids for cancer, palliative care or substance use disorder, medical conditions contraindicating the use of tapentadol or oxycodone, opioid hypersensitivity, taking medications which are contraindicated for use with oxycodone or tapentadol

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)
Randomisation will be conducted using a centralised randomisation service to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised on admission in a 1:1 ratio in permuted blocks of 2 and 4 to: (1) tapentadol plus usual care post-surgery and on discharge if required; or (2) oxycodone plus usual care post-surgery and on discharge if required. The method of generating the allocation sequence is computer generated random numbers. The randomisation will be stratified by hospital site.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318373 0
University
Name [1] 318373 0
University of Sydney PhD Scholarship
Country [1] 318373 0
Australia
Funding source category [2] 319607 0
University
Name [2] 319607 0
University of Sydney staff in-kind support
Country [2] 319607 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320771 0
None
Name [1] 320771 0
Address [1] 320771 0
Country [1] 320771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317004 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317004 0
Ethics committee country [1] 317004 0
Australia
Date submitted for ethics approval [1] 317004 0
Approval date [1] 317004 0
09/04/2025
Ethics approval number [1] 317004 0
2024/ETH02671

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

Contacts
Principal investigator
Name 139706 0
A/Prof Jonathan Penm
Address 139706 0
N371, Pharmacy and Bank Building A15 The University of Sydney, NSW, 2006
Country 139706 0
Australia
Phone 139706 0
+61 286275806
Fax 139706 0
Email 139706 0
[email protected]
Contact person for public queries
Name 139707 0
Jonathan Penm
Address 139707 0
N371, Pharmacy and Bank Building A15 The University of Sydney, NSW, 2006
Country 139707 0
Australia
Phone 139707 0
+61 286275806
Fax 139707 0
Email 139707 0
[email protected]
Contact person for scientific queries
Name 139708 0
Jonathan Penm
Address 139708 0
N371, Pharmacy and Bank Building A15 The University of Sydney, NSW, 2006
Country 139708 0
Australia
Phone 139708 0
+61 286275806
Fax 139708 0
Email 139708 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]


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.