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Responsible opioid use before hip and knee replacement surgery

Feasibility of responsible pre-operative opioid use for Hip and knee ArthropLasTy (OpioidHALT) pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000919819
Enrollment
70
Registered
2021-07-15
Start date
2021-12-27
Completion date
2022-09-22
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery. Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use. The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomised to either a usual waiting list experience or to having a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualised tapering that supports the patient, provides them with information relevant to their circumstances and allows their control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group. This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas. Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anaesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.

Interventions

OpioidHALT: This will be a randomised controlled pilot study to establish the feasibility and acceptability of an intervention on the preoperative reduction of opioid use before elective THA or TKA compared to usual practice. Participants will be randomised in a 1:1 ratio to: (1) pharmacist tele-health consultation to individualise pain management and opioid tapering plans; or (2) usual care (Control). Intervention - Pharmacist-led opioid tapering: A pharmacist will contact the patient's Genera

OpioidHALT: This will be a randomised controlled pilot study to establish the feasibility and acceptability of an intervention on the preoperative reduction of opioid use before elective THA or TKA compared to usual practice. Participants will be randomised in a 1:1 ratio to: (1) pharmacist tele-health consultation to individualise pain management and opioid tapering plans; or (2) usual care (Control). Intervention - Pharmacist-led opioid tapering: A pharmacist will contact the patient's General Practitioner (GP) by telephone to outline the intervention and address any concerns raised. With the GP’s approval for his/her patient to participate in the trial, the pharmacist will proceed to contact the participant. Participants will receive tele-health consultations with a Home Medicines Review accredited pharmacist. Pharmacist consultations will be based off the Behaviour Change Wheel for behaviour change interventions. The pharmacist will complete a pain management plan and an opioid weaning plan with the patient. We will use the pain management plan from NPS Medicinewise Australia, which will be tailored to the individual. A pharmacist trained in pain self-management will provide education on the development of pain self-management skills such as participating in physical exercise, learning relaxation techniques and implementing sleep hygiene practices. Necessary referrals to other health care professionals, such as physiotherapists, will be communicated to the patient’s GP to coordinate the patient’s care. The NPS opioid weaning plan will be used and involves an individualised tapering rate of 10-25% of the original opioid dose per week for patients on opioids for less than three months. Patients taking opioids for three or more months will taper opioids at a rate of 10-25% of the original opioid dose per month. The rate and end-point of opioid tapering will be guided by the pharmacist but will be patient-led, and individualised for dose, length of use and patient circumstances. The pharmacist will educate the patient on specific steps for the management of potential opioid withdrawal effects or increased pain. For example, if withdrawal effects are experienced, the patient will be instructed to pause tapering their opioid dose. If pain is experienced, the patient will be instructed to employ pain self-management strategies. If these effects persist, the patient will be instructed to increase their opioid dose. If withdrawal effects or pain persist beyond this, the patient will be instructed to see their GP. The completed pain management plan and opioid tapering plan will be reviewed by an Anaesthetist to ensure safety and effectiveness before they are sent to the patient’s GP to ensure continuity of care. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction to review tapering progress, address any difficulties encountered and adjust the opioid tapering plan as required. Opioid dose reduction will continue until a target of > 50% of the original daily opioid dose is tapered and the patient is clinically stable, without experiencing physical or psychological discomfort. The intervention will be administered a minimum of 3 and maximum of 12 months before surgery. Each telehealth consultation will be administered as at least 4 weekly sessions. Each session will approximately be 30 minutes in duration. Patients will receive a minimum of 3 sessions over approximately 3 months. Adherence to the intervention will be monitored using session attendance checklists and standard documentation forms. If the intervention ends before the patient is due for surgery, the patient will be asked to continue tapering their opioid dose with their GP using the given plans until the day of surgery. Patients who are ineligible for participation in the trial due to attendance at a pain clinic or those who are eligible but decline participation in the randomised trial will be invited to join an observation group. From the observation group, we will collect data by telephone at 3 months before surgery, 1 to 3 days before surgery, as well as information related to hospital stay upon hospital discharge from the electronic health record as outlined above. Patients will be offered a $50 gift card by email or by postage per telephone interview in return for their time. The value of the Observational arm is to provide a snapshot of opioid use of patients currently being managed by pain clinics. We will be able to see if opioid use among such patients increases or decreases whilst under the care of the clinic, thus providing indirect evidence of the need for an alternative intervention to help lower opioid use. In addition, there is a possibility we will recruit the people most keen to wean off their medications. By capturing data and following those who are eligible but are reluctant to participate in the randomize trial, we can compare whether those who refused have different characteristics to those who agree, and also obtain information about whether people are self-weaning or, conversely, actually increasing their opioid intake, and what happens to them.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Randomised Study: Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone. Observational Arm: Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone, attending pain clinic, under the care of a pain specialist or already undergoing opioid tapering or previously participated in an opioid tapering study.

Exclusion criteria

Randomised Study: Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, already undergoing or previously participated in an opioid tapering study, comorbid cognitive impairment or intellectual disability, currently attending a pain clinic or under the care of a pain specialist. Observational Arm: Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, comorbid cognitive impairment or intellectual disability.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026