Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000701628
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
30/06/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Opioid weaning program prior to total knee replacement
Scientific title
Implementation of an opioid weaning program prior to total knee replacement (TKR): feasibility and effect on postoperative outcomes
Secondary ID [1] 309258 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid analgesia 329414 0
Knee oestoarthritis 329415 0
Condition category
Condition code
Anaesthesiology 326358 326358 0 0
Pain management
Anaesthesiology 326359 326359 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the active group of the study (those on the TKR surgery waitlist with with OMEDD
>30) will participate in the Empowered Relief (ER) program. ER is a two-hour education session that
will be delivered to groups of 10 study participants, either face to face or online. Face to face
sessions will be conducted at TQEH, and online sessions delivered via Zoom.
The session will be conducted by a Psychologist who is a certified ER Instructor. Participants will
receive the program approximately six months prior to surgery. Three ER sessions will be conducted
every six months over the course of the 2-year study period, to capture the full 110 patients
required for the study.
Content of the program includes:
• pain neuroscience education
• training in three core pain management skills: relaxation; cognitive reframing; self-soothing
techniques.
• development of a personalised plan for pain management.
Participants will also be supplied with the following patient-facing materials:
• a binaural audiofile (MP4) via the ER webpage for daily experience of the relaxation
response
• paper copy of the ER presentation slides
• paper copy of a pain survey for participants to self-identify their pain-related thoughts
• a form for recording their personalised plan for pain management
Neither the pain survey nor the personalised plan is collected by the ER Instructor; the patient-facing
materials are for the personal use of ER participants only. All ER materials are copyrighted and
internationally trademarked by Stanford University, and delivery of the certified program may not be
altered in any way.
Participants will complete a biopsychosocial screen when enrolling in the study, consisting of
DASS21, PCS, Revised Opioid Risk Tool, Oxford Knee Score, Knee Outcome Survey – Activities of Daily
Living, and Charlson comorbidity index, as per the study protocol. These will be administered and
scored by the Research Assistant. Immediately prior to surgery, all patients in the active group will
repeat the biopsychosocial screening measures, to allow pre-post comparison of the ER intervention
and weaning period. Participants will also complete a post-surgery satisfaction questionnaire
regarding the weaning program.
Intervention code [1] 325693 0
Behaviour
Intervention code [2] 325694 0
Treatment: Other
Comparator / control treatment
Control patients (who do not use opioid analgesia) will be used as a comparator given they will not recieve any of the above treatment.
Control group
Active

Outcomes
Primary outcome [1] 334214 0
Percentage of opioid tolerant patients who successfully wean opioid use greater than/equal to 50% prior to elective knee replacement. This will be collected via phone interview and data linked to prescriptions for each individual patient.
Timepoint [1] 334214 0
At time of surgery
Secondary outcome [1] 419858 0
Knee range of motion (ROM) post op day 1 onwards through admission and 3/6/12 months combined with 6 minute walk test (6MWT)
Timepoint [1] 419858 0
Collected daily by acute pain service (APS)/orthopaedic staff during inpatient stay. Completed by research staff/GP follow up at 3/6/12 month timepoints.
Secondary outcome [2] 422828 0
Cumulative postoperative opioid consumption - collected by APS team during inpatient stay from medical records
Timepoint [2] 422828 0
Daily totals from day 1 post operation until discharge
Secondary outcome [3] 422831 0
Hospital length of stay (in days) (from medical records)
Timepoint [3] 422831 0
Recorded at discharge.
Secondary outcome [4] 422832 0
Pain assessment from postoperative day 1 while in hospital. Measured as visual analogue scale (VAS) as a well validated and standardised scoring system.
Timepoint [4] 422832 0
Daily during inpatient admission until discharge
Secondary outcome [5] 422833 0
Oxford Knee Score (composite outcome as a validated knee specific questionaire for function)
Timepoint [5] 422833 0
At 3, 6 and 12 months from operation date by phone follow up and researcher review.
Secondary outcome [6] 422834 0
Surgical site and prosthetic joint infections (PJI)
Timepoint [6] 422834 0
Measured by phone follow up/medical records review at 12 months from operation.
Secondary outcome [7] 422835 0
Revision surgery rates at 1 year (recorded by research staff reviewing medical records)
Timepoint [7] 422835 0
At 12 months from operation date.
Secondary outcome [8] 422836 0
Prolonged opioid use at greater than 3 months from surgery date. Measured by phone call from research staff and patient reporting.
Timepoint [8] 422836 0
At 3 months from operation date.
Secondary outcome [9] 422837 0
Perceptions of the weaning program for all groups. Measured by Likert scale performed by research staff as phone interview.
Timepoint [9] 422837 0
At 1 month from operation date.
Secondary outcome [10] 423391 0
Functional activity score (FAS) to assess function as an outcome secondary to pain.
Timepoint [10] 423391 0
Daily assessment by APS team during admission.

Eligibility
Key inclusion criteria
- Prospective TKR patients using greater than/equal to 30mg oral morphine equivalent daily dose (oMEDD)
- At least 6 months prior to TKR at time of recruitment
- Willingness to engage with study and intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unwilling to engage with intervention
- Patient general practitioner unwilling to supervise opioid weaning process over course of study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
-
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Three arms;
1. Opioid group who successfully wean at least 50% of their individual oMEDD at time of operation (Group W)
2. Opioid group who are not successful in weaning at least 50% of their individual oMEDD at time of operation (Group UW)
3. Control group who are not using opioid analgesia (Group C)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
11/08/2025
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24366 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 39950 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 313450 0
Charities/Societies/Foundations
Name [1] 313450 0
Australian and New Zealand College of Anaesthetists
Country [1] 313450 0
Australia
Primary sponsor type
Hospital
Name
Central Adelaide Local Health Network
Address
28 Woodville Road, Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 315290 0
None
Name [1] 315290 0
Address [1] 315290 0
Country [1] 315290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312653 0
Human Research Ethics Committee - Central Adelaide Local Health Network
Ethics committee address [1] 312653 0
Ethics committee country [1] 312653 0
Australia
Date submitted for ethics approval [1] 312653 0
29/03/2023
Approval date [1] 312653 0
04/04/2023
Ethics approval number [1] 312653 0
2022/HRE00263

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

Contacts
Principal investigator
Name 125434 0
A/Prof Venkatesan Thiruvenkatarajan
Address 125434 0
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country 125434 0
Australia
Phone 125434 0
+61 0882226640
Fax 125434 0
Email 125434 0
[email protected]
Contact person for public queries
Name 125435 0
Venkatesan Thiruvenkatarajan
Address 125435 0
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country 125435 0
Australia
Phone 125435 0
+61 0882226000
Fax 125435 0
Email 125435 0
[email protected]
Contact person for scientific queries
Name 125436 0
Venkatesan Thiruvenkatarajan
Address 125436 0
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South, SA 5011
Country 125436 0
Australia
Phone 125436 0
+61 0882226640
Fax 125436 0
Email 125436 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
Private and potentially identifiable information


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.