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Trial registered on ANZCTR


Registration number
ACTRN12617001423303
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
9/10/2017
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-operative outcomes following total joint replacement in successfully weaned chronic opioid users compared to those who do not wean: a randomised controlled trial
Scientific title
Post-operative outcomes following total joint replacement in successfully weaned chronic opioid users compared to those who do not wean: a randomised controlled trial
Secondary ID [1] 293068 0
None
Universal Trial Number (UTN)
U1111-1203-2175
Trial acronym
COPTJA
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic opioid use 304999 0
Total joint arthroplasty 305000 0
Condition category
Condition code
Anaesthesiology 304321 304321 0 0
Pain management
Surgery 304322 304322 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients enrolled in the study will be taking opioids for equal to or greater than 4 weeks, and be scheduled for a total joint arthroplasty. The intervention will be to wean one group of patients to at least 50% of the morphine-equivalent dose (MED) prior to surgery. This weaning will take place over eight (8) weeks pre-operatively.

Incremental dose changes and timings will adhere to following protocol:
Time: Weekly change in opioid dose (current dose as percentage of initial)
Initial opioid dose per day (ti): 100%
Week 1 (t-8): -5% (95%)
Week 2 (t-7): -5% (90%)
Week 3 (t-6): -5% (85%)
Week 4 (t-5): -10% (75%)
Week 5 (t-4): -5% (70%)
Week 6 (t-3): -5% (65%)
Week 7 (t-2): -5% (60%)
Week 8 (t-1): -10% (50%)
Day of Operation (t0): 50%

Mode of administration of all opioids will be oral.

The study will approach patient weaning protocol pragmatically, and thus normal variations in opioid weaning levels per week are expected and are part of the study examination. Patients will be required to track their opioid usage on a ‘Pre-Operative Opioid Usage’ form to ensure compliance.

Participants in the intervention group will be provided with information sheets regarding pain management. These will include pain experience expectation information, non-pharmacological management techniques, and what to do if the plan does not work.
Clear stopping rules related to pain thresholds will be implemented during the weaning phase. Patients will be advised on the Patient Information and Consent Form that if their pain reaches a level above seven (7) on the VAS, or six (6) on the VAS with associated mild opioid withdrawal symptoms, or four (4) on the VAS with moderate opioid withdrawal symptoms, or if they experience severe opioid withdrawal symptoms at any point, then they must undo their most recent opioid decrease, and contact their GP, who will in turn contact the lead- or co-investigators when next practical to seek further advice.

Intervention code [1] 299309 0
Treatment: Drugs
Comparator / control treatment
The control group will be those patients who are taking opioids for equal to or greater than 4 weeks, and do not wean (i.e. continue taking their opioids as usual up to the date of surgery).
Control group
Active

Outcomes
Primary outcome [1] 303587 0
Time to discharge after primary unilateral total joint arthroplasty.
Timepoint [1] 303587 0
Measured in days from date of surgery until date of discharge.
Secondary outcome [1] 339496 0
Opioid consumption (in milligrams of morphine-equivalent dose).
Post-operative opioid consumption will include opioid analgesics required as per cardiovascular requirements in the PACU, and opioid analgesics self-administered via PCA. Any opioids used will be converted to morphine-equivalent doses, and total overall doses will be measured.
Timepoint [1] 339496 0
Measured at several timepoints:
- Initial appointment.
- Day of surgery.
- In post-anaesthetic care unit (PACU).
- Post-operative day (POD) 1 +/- first mobilisation.
- POD2
- POD3 or discharge, whichever is sooner.
- Six (6) week follow-up appointment.
- Six (6) month follow-up appointment.
Secondary outcome [2] 339497 0
Subjective pain scores (measured using the pain visual analogue scale (VAS))
Timepoint [2] 339497 0
Measured at several timepoints:
- Initial appointment.
- In post-anaesthetic care unit (PACU).
- POD1 +/- first mobilisation.
- POD2
- POD3 or discharge, whichever is sooner.
Secondary outcome [3] 339498 0
Total medication usage (including non-opioid analgesics).
Patients will be provided with a template to record any analgesics used from the day of discharge until the six-week follow-up appointment in. Analgesics include any types of painkillers (e.g. paracetamol, Panadeine Forte, ibuprofen,
Nurofen, endone, targin, etc.).
Timepoint [3] 339498 0
Measured at several timepoints:
- Initial appointment.
- Day of surgery.
- In post-anaesthetic care unit (PACU).
- POD1 +/- first mobilisation.
- POD2
- POD3 or discharge, whichever is sooner.
- Six (6) week follow-up appointment.
Secondary outcome [4] 339499 0
Quality of life (measured using the Short-Form 36 (SF36) survey)
Timepoint [4] 339499 0
Measured at several timepoints:
- Initial appointment.
- Six (6) week follow-up appointment.
- Six (6) month follow-up appointment.
Secondary outcome [5] 339500 0
Beliefs about medication usage (measured using the Beliefs about Medication Questionnaire (BMQ)).
Timepoint [5] 339500 0
Measured at several timepoints:
- Initial appointment.
- Six (6) week follow-up appointment.
- Six (6) month follow-up appointment.
Secondary outcome [6] 339501 0
Functional capacity of joint (measured using the Oxford Hip Score and Oxford Knee Score respectively)
Timepoint [6] 339501 0
Measured at several timepoints:
- Initial appointment.
- Six (6) month follow-up appointment.
Secondary outcome [7] 339502 0
Adverse events (coded using the Common Terminology Criteria for Adverse Events (CTCAE)).
Known/possible adverse events include opioid-induced hyperalgesia, signs and symptoms of opioid withdrawal (e.g. nausea, muscle cramping, depression, agitation, anxiety, opiate cravings).
Timepoint [7] 339502 0
Measured at several timepoints:
- Day of surgery.
- In post-anaesthetic care unit (PACU).
- POD1 +/- first mobilisation.
- POD2
- POD3 or discharge, whichever is sooner.
- Six (6) week follow-up appointment.
- Six (6) month follow-up appointment.

Eligibility
Key inclusion criteria
- Scheduled to undergo total hip or knee arthroplasty.
- Treated with opioid therapy for at least four (4) weeks prior to baseline appointment.
- At least eighteen (18) years of age.
- Able to speak English.
- Able to comprehend the information in supporting and consenting documents.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current smokers
- Schedule to undergo bilateral arthroplasty surgery.
- Have a documented history of drug or alcohol addiction, or drug-seeking behaviour.
- Have a documented history of any psychiatric condition, including depression.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297689 0
Hospital
Name [1] 297689 0
Mackay Base Hospital
Address [1] 297689 0
475 Bridge Rd
West Mackay QLD 4740
Country [1] 297689 0
Australia
Primary sponsor type
Individual
Name
Grant Breadsell
Address
Mackay Base Hospital
Queensland Health
475 Bridge Rd
West Mackay QLD 4740
Country
Australia
Secondary sponsor category [1] 296712 0
Individual
Name [1] 296712 0
Daniel Bartlett
Address [1] 296712 0
Mackay Base Hospital
Queensland Health
475 Bridge Rd
West Mackay QLD 4740
Country [1] 296712 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298762 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298762 0
Townsville Research Education Support and Administration (TRESA), Level 1, The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Ethics committee country [1] 298762 0
Australia
Date submitted for ethics approval [1] 298762 0
27/03/2017
Approval date [1] 298762 0
26/06/2017
Ethics approval number [1] 298762 0
HREC/17/QTHS/35

Summary
Brief summary
Opioid pain medication (e.g. codeine, morphine, etc.) can be very effective in controlling pain. It has been used more and more across the world over the last 20 years. It is mostly used for patients with pain caused by chronic disease (e.g. cancer).
Unfortunately, taking opioid medication can lead to detrimental side effects. These side effects can include increased sensitisation to pain (hyperalgesia) and the body becoming more used to opioid medication (tolerance), and therefore requiring higher doses to get any effect. There is mounting evidence that when taken before joint replacements, opioids can lead to poor outcomes after surgery.

This study aims to investigate whether patients can minimise their dose of opioid medication before surgery, and if they can, if minimising the dose leads to an improvement in their condition after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78146 0
Dr Grant Breadsell
Address 78146 0
Mackay Base Hospital
Queensland Health
475 Bridge Rd
West Mackay QLD 4740
Country 78146 0
Australia
Phone 78146 0
+617 48856000
Fax 78146 0
Email 78146 0
gbreadsell@gmail.com
Contact person for public queries
Name 78147 0
Dr Grant Breadsell
Address 78147 0
Mackay Base Hospital
Queensland Health
475 Bridge Rd
West Mackay QLD 4740
Country 78147 0
Australia
Phone 78147 0
+617 48856000
Fax 78147 0
Email 78147 0
grant.breadsell@health.qld.gov.au
Contact person for scientific queries
Name 78148 0
Dr Grant Breadsell
Address 78148 0
Mackay Base Hospital
Queensland Health
475 Bridge Rd
West Mackay QLD 4740
Country 78148 0
Australia
Phone 78148 0
+617 48856000
Fax 78148 0
Email 78148 0
grant.breadsell@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable