None listed
Conditions
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.
Interventions
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 opio
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.
Sponsors
Grant Breadsell
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed