Why is opioid use before hip or knee replacement a problem?

Patients who require THA or TKA suffer from end stage osteoarthritis with chronic pain. Opioids often provide no better pain relief that simple analgesics and yet they carry the risk of additional side effects such as drowsiness and the risk of falls. Moreover, opioid use before surgery is linked to worse outcomes including slower recovery and persistent opioid use three months after surgery.

THA and TKA are among the most common elective surgical procedures performed around the world and numbers are expected to at least double over the next decade.

The OpioidHALT trial (Feasibility of responsible pre-operative opioid use for Hip and knee ArthropLasTy (OpioidHALT) pilot study) was designed to examine the feasibility and acceptability of an intervention to reduce opioid use before elective THA or TKA compared to usual practice.

How OpioidHALT tackles pre-operative opioid use?

There is little published evidence for the effectiveness of opioid dose tapering. One previous retrospective study showed that patients who tapered their opioids before surgery might have better post-surgical outcomes. However, as the study was not randomised it was not known if there was something different about the patients who tapered their doses.

The OpioidHALT study involved video or telephone consultations with a pharmacist starting three months before the date of the operation. The pharmacist worked with each patient to develop an opioid tapering plan that was evaluated for safety by a pain specialist. Patients determined the level of opioid tapering that they wished within the framework of national guidelines i.e. 10 to 25% of the patient’s baseline opioid dose tapered per month.

What the OpioidHALT pilot study tells us

The initial consultations in the OpioidHALT study took about one hour. Follow-up appointments started one week after each dose reduction and were typically shorter, Patients were educated about how to identify and manage opioid withdrawal symptoms. “If necessary, the patient was put back on a higher opioid dose”, says Dr Liu.

OpioidHALT was a pilot study designed to determine whether the intervention delivered by pharmacists led to successful tapering of opioid doses. The results showed that in the intervention group 90% of patients tapered their opioid doses by at least 50% before surgery compared with17% in the usual care group.

Although the pilot study was not powered to evaluate other outcomes, some of the emerging findings suggest important impacts. In the intervention group there were –

• Fewer opioids consumed in hospital
• Smaller quantities of opioids supplied on discharge
• Fewer days in hospital
• Fewer patients taking opioids three months post-operation

Patients in the intervention group also had improved physical function and improved overall body pain intensity.

Why pharmacists should manage pre-operative opioid use

As a result of the impressive results from the OpioidHALT study Dr Jonathan Penm has now received funding of $1.5 million to run the definitive trial (OpioidHALT II). Recruitment started two months ago.

Recordings of the consultations showed that many patients were keen to discontinue opioid use but needed help with the process. “We’ve got patients who are crying [out] to have pharmacists to be more involved in their care …. and that’s something that a lot of pharmacists can do”, says Dr Penm. He adds that the whole multidisciplinary research team says “This is a really good intervention, we should be doing this, pharmacists should be leading it”

About Dr Shania Liu and Dr Jonathan Penm

Dr Shania Liu  BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FSHP, FHEA completed her PhD at the University of Sydney looking at a pharmacist-led opioid tapering program for patients undergoing total hip and knee arthroplasty. Currently, she is a post-doctoral research fellow working at the University of Alberta in Canada where she is leading two large randomised trials looking at pharmacist-partnered management of chronic conditions such as cardiovascular disease. She also  continues to be involved in the pharmacist-led opioid tapering work looking at the impacts of opioid tapering before hip and knee replacement surgery.

At the 2024 FIP Congress Dr Liu was awarded the International Pharmaceutical Federation Early Career in Pharmaceutical Practice Recognition Award. The purpose of the award is to recognise an outstanding early career pharmacist who has made important contributions to their field of practice at a national level, and who is emerging internationally.

Dr Jonathan Penm BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FFIP, FSHP, FPS, FHEA, FANZCAP (PainMgmt, Research) is a senior lecturer at the University of Sydney School of Pharmacy in Australia. He is involved in both teaching and research and is also affiliated with the Prince of Wales Hospital, where he is involved in research with the pain team. His area of interest is evaluating hospital pharmacy services to reduce patient harm and the need for hospital care.  He currently runs several randomised controlled trials and is the Principal Investigator for OpioidHALT II.

Read and watch the full series on our website or on YouTube.

Some 575 patients were screened for inclusion in the OpioidHALT study and 442 were excluded because of low opioid use. “That is the reality of clinical trials for you”, says Dr Shania Liu. “We know that approximately a quarter of patients in [this] population don’t use opioids on a regular basis”, she adds. Nevertheless, dosage tapering is still important for the many patients who are using opioids regularly.

OpioidHALT II

As a result of the impressive results from the OpioidHALT study Dr Jonathan Penm has now received funding of $1.5 million to run the definitive trial (OpioidHALT II). Recruitment started two months ago.  “What’s great about it is all of the pilot sites were so impressed by the pilot that they’ve all stayed on for this definitive trial. Other sites have also expressed interest because they’ve been so excited about it”, says Dr Penm. “We’re going to have more pharmacists, a lot more patients – and [it] will be primarily powered to look at those pain and quality of life outcomes”, he explains.

Pharmacists often improve medication regimens but rarely find out how much of an impact the changes have on patients’ lives. One of the useful and important findings in the OpioidHALT study was that the early benefits of reduced opioid use were sustained for three months. “It just shows you the value that pharmacists can provide to their patients – that when we improve their medicines we could be improving it for much, much longer than you realise and having much, much stronger impact”, says Dr Penm.

All the opioid-tapering consultations were recorded and patients’ reactions made a profound impact on Dr Penm.

“Many of them were just so grateful to have someone listen to them,  to validate what they’ve been going through with their pain and to support them through the opioids. In fact, most of them said, “I’ve never had any benefit from these but I just don’t know how to get off them – and I really would love some help”,  so I think we’ve got patients who are crying [out] to have pharmacists to be more involved in their care, to be more present, to listen to them, to validate what they’re going through – and that’s something that a lot of pharmacists can do”, he says.

In summary Dr Penm says:

“Any work of this calibre is extremely difficult to do with one person and we have a very large team. One of the unique aspects is how multidisciplinary it was – we have pharmacists, we have nurses, we have GPs, we have anaesthetists, we have physiotherapists, we have orthopaedic surgeons – and we know how rare it is to get all these people together in one spot and for all of them to say, “This is a really good intervention, we should be doing this, pharmacists should be leading it”. It’s just beautiful to hear. You don’t always hear that the pharmacist is the most obvious choice but in this case they are. They’re happy, they’re competent, they’re capable – and everyone else doesn’t want to do this because it is not their area of expertise. Well, with pharmacy we’re very comfortable because we know this, we know opioids, we see tapering, we know how to taper, we know what to expect”.

About Dr Shania Liu and Dr Jonathan Penm

Dr Shania Liu  BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FSHP, FHEA completed her PhD at the University of Sydney looking at a pharmacist-led opioid tapering program for patients undergoing total hip and knee arthroplasty. Currently, she is a post-doctoral research fellow working at the University of Alberta in Canada where she is leading two large randomised trials looking at pharmacist-partnered management of chronic conditions such as cardiovascular disease. She also  continues to be involved in the pharmacist-led opioid tapering work looking at the impacts of opioid tapering before hip and knee replacement surgery.

Dr Jonathan Penm BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FFIP, FSHP, FPS, FHEA, FANZCAP (PainMgmt, Research) is a senior lecturer at the University of Sydney School of Pharmacy in Australia. He is involved in both teaching and research and is also affiliated with the Prince of Wales Hospital, where he is involved in research with the pain team. His area of interest is evaluating hospital pharmacy services to reduce patient harm and the need for hospital care.  He currently runs several randomised controlled trials and is the Principal Investigator for OpioidHALT II.

Read and watch the full series on our website or on YouTube.

The initial consultations in the OpioidHALT study – when the opioid tapering plans were developed took about one hour. Follow-up appointments started one week after each dose reduction to check on progress and safety; these were typically shorter, explains Dr Shania Liu. Opioid withdrawal symptoms were one obvious concern. Dr Liu emphasises that the tapering rate was very gradual to minimise the risks of opioid withdrawal and patients were educated about what to look out for and how to overcome withdrawal symptoms. “If necessary the patient was put back on a higher opioid dose to ….. ensure that patient safety came first”, she says.  In fact, all adverse events were recorded during the study.

OpioidHALT findings

OpioidHALT was a pilot study designed to determine whether the intervention delivered by pharmacists led to successful tapering of opioid doses, explains Dr Jonathan Penm. “We also found that currently GPs or primary care physicians are generally responsible for opioid tapering, but that’s not their happy place – they were not comfortable, they did not want to spend their time on that”, he says.  However, pharmacists were keen to undertake this work.  The results showed that in the intervention group 90% of patients tapered their opioid doses by at least 50% before surgery compared with17% in the usual care group. “As a researcher it’s very rare to see such large differences – 17% versus 90%”, says Dr Penm.

Although the pilot study was not powered to evaluate other outcomes, some of the emerging findings suggest important impacts.  Those patients whose opioid doses were tapered before surgery consumed fewer opioids in hospital and received smaller quantities of opioids at discharge.  In addition, the length of hospital stay was shorter (4 days versus 5.6 days) in the intervention group. Three months after the surgery those in the intervention group were much less likely to be taking opioids than those in the control group. They also had improved physical function and  improved overall body pain intensity. Dr Penm notes that “it’s not powered for that so we do have to be a bit cautious  – but these are very promising results”.

About Dr Shania Liu and Dr Jonathan Penm

Dr Shania Liu  BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FSHP, FHEA completed her PhD at the University of Sydney looking at a pharmacist-led opioid tapering program for patients undergoing total hip and knee arthroplasty. Currently, she is a post-doctoral research fellow working at the University of Alberta in Canada where she is leading two large randomised trials looking at pharmacist-partnered management of chronic conditions such as cardiovascular disease. She also  continues to be involved in the pharmacist-led opioid tapering work looking at the impacts of opioid tapering before hip and knee replacement surgery.

At the 2024 FIP Congress Dr Liu was awarded the International Pharmaceutical Federation Early Career in Pharmaceutical Practice Recognition Award. The purpose of the award is to recognise an outstanding early career pharmacist who has made important contributions to their field of practice at a national level, and who is emerging internationally.

Dr Jonathan Penm BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FFIP, FSHP, FPS, FHEA, FANZCAP (PainMgmt, Research) is a senior lecturer at the University of Sydney School of Pharmacy in Australia. He is involved in both teaching and research and is also affiliated with the Prince of Wales Hospital, where he is involved in research with the pain team. His area of interest is evaluating hospital pharmacy services to reduce patient harm and the need for hospital care.  He currently runs several randomised controlled trials and is the Principal Investigator for OpioidHALT II.

Read and watch the full series on our website or on YouTube.

The case for reducing opioid treatment slowly before total hip and knee replacements is compelling, according to Dr Jonathan Penm. Many patients with osteoarthritis are taking opioids but “we know opioids are not the most effective medicine for osteoarthritis, so we’ve got a cohort of people taking a medicine that doesn’t have much evidence, that’s not very effective and comes with a lot of side effects”, he explains. Reducing the opioid doses is unlikely to make pain any worse but it could reduce the risk of harms, he adds. He notes that there is little evidence for the effectiveness of opioid dose tapering.  One previous retrospective study had shown that patients who tapered their opioids before surgery might have better post-surgical outcomes. However, as the study was not randomised it was not known if there was something different about the patients who tapered their doses. “They might just be patients who would naturally taper who weren’t as sick and so they have better outcomes – and so we just didn’t know if these harms were reversible”, he says.

OpioidHALT – objectives and methods

The objective of OpioidHALT study was to examine the feasibility and effectiveness of a pharmacist-led intervention to taper opioid dosage before hip and knee replacement surgery, compared with usual care.  The intervention was delivered via a video or telephone consultation. “Pharmacists and patients met ‘one-on-one’ over a Zoom meeting or over a telephone call and discussed their pain management and opioid use before surgery – approximately three months before their joint replacement surgery – with the aim to gradually taper their opioid dose until the day of their surgery”, explains Dr Shania Liu.

For this pilot study a single pharmacist based in the community conducted all the consultations. The pharmacist was trained using freely available, online resources. “We recently published a training package summarising these resources so any pharmacist can access them”, says Dr Liu. The pharmacist worked with each patient to  develop an opioid tapering plan that was evaluated for safety by a pain specialist. In addition, the GP was kept in the loop at all stages. Dr Liu emphasises the patient-centred nature of the consultations. “Patients could lead the level of opioid tapering that they wished. The opioid tapering rate, however, was guided by national guidelines on opioid tapering rates. So, this was, on average, 10 to 25% of the patient’s baseline opioid dose tapered per month – so quite gradual – and we did monitor for safety”, she says. Furthermore, patients were offered simple analgesics and non-pharmacological approaches to ensure that pain was managed whilst the opioid doses were being tapered.

About Dr Shania Liu and Dr Jonathan Penm

Dr Shania Liu  BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FSHP, FHEA completed her PhD at the University of Sydney looking at a pharmacist-led opioid tapering program for patients undergoing total hip and knee arthroplasty. Currently, she is a post-doctoral research fellow working at the University of Alberta in Canada where she is leading two large randomised trials looking at pharmacist-partnered management of chronic conditions such as cardiovascular disease. She also  continues to be involved in the pharmacist-led opioid tapering work looking at the impacts of opioid tapering before hip and knee replacement surgery.

At the 2024 FIP Congress Dr Liu was awarded the International Pharmaceutical Federation Early Career in Pharmaceutical Practice Recognition Award. The purpose of the award is to recognise an outstanding early career pharmacist who has made important contributions to their field of practice at a national level, and who is emerging internationally.

Dr Jonathan Penm BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FFIP, FSHP, FPS, FHEA, FANZCAP (PainMgmt, Research) is a senior lecturer at the University of Sydney School of Pharmacy in Australia. He is involved in both teaching and research and is also affiliated with the Prince of Wales Hospital, where he is involved in research with the pain team. His area of interest is evaluating hospital pharmacy services to reduce patient harm and the need for hospital care.  He currently runs several randomised controlled trials and is the Principal Investigator for OpioidHALT II.

Read and watch the full series on our website or on YouTube.

Patients who undergo total hip (THA) and total knee replacement surgery (TKA) suffer from end stage osteoarthritis with chronic pain. “We know from existing research that opioids are often no better than simple analgesics like paracetamol or acetaminophen or anti-inflammatory pain medicines for osteoarthritis-related pain – so these opioids are not providing any additional benefit and yet they carry the risk of additional side effects such as drowsiness and the risk of falls”, explains Dr Liu. Moreover, opioid use before surgery is linked to worse outcomes including slower recovery and persistent opioid use three months after surgery, she adds.

The OpioidHALT trial (Feasibility of responsible pre-operative opioid use for Hip and knee ArthropLasTy (OpioidHALT) pilot study) was designed to examine the feasibility and acceptability of an intervention to reduce opioid use before elective THA or TKA compared to usual practice. “Total hip and knee replacement surgeries are among the most common elective surgical procedures performed around the world with over 1 million of these procedures performed in the USA alone in 2021.  As we know, the population as a whole is aging so these procedures are expected to at least double in volume over the next decade”, explains Dr Liu

About Dr Shania Liu and Dr Jonathan Penm

Dr Shania Liu  BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FSHP, FHEA completed her PhD at the University of Sydney looking at a pharmacist-led opioid tapering program for patients undergoing total hip and knee arthroplasty. Currently, she is a post-doctoral research fellow working at the University of Alberta in Canada where she is leading two large randomised trials looking at pharmacist-partnered management of chronic conditions such as cardiovascular disease. She also  continues to be involved in the pharmacist-led opioid tapering work looking at the impacts of opioid tapering before hip and knee replacement surgery.

At the 2024 FIP Congress Dr Liu was awarded the International Pharmaceutical Federation Early Career in Pharmaceutical Practice Recognition Award. The purpose of the award is to recognise an outstanding early career pharmacist who has made important contributions to their field of practice at a national level, and who is emerging internationally.

Dr Jonathan Penm BPharm (Hons), GradCertEdStud (Higher Ed), PhD, FFIP, FSHP, FPS, FHEA, FANZCAP (PainMgmt, Research) is a senior lecturer at the University of Sydney School of Pharmacy in Australia. He is involved in both teaching and research and is also affiliated with the Prince of Wales Hospital, where he is involved in research with the pain team. His area of interest is evaluating hospital pharmacy services to reduce patient harm and the need for hospital care.  He currently runs several randomised controlled trials and is the Principal Investigator for OpioidHALT II.

Read and watch the full series on our website or on YouTube.