None listed
Conditions
Brief summary
Total knee replacement (TKR) rates in Australia have increased from 123 to 242 per 100,000 population from 2013-2016. By 2030, this is projected to rise by 276% (I. N. Ackerman et al., 2019; Adie, Harris, Chuan, Lewis, & Naylor, 2019). In the Central Adelaide Local Health Network, since July 2016, there has been 709 total knee replacements (both primary and revision) completed at The Queen Elizabeth Hospital (TQEH). The use of opioids before joint replacement surgery has been associated with poorer postoperative outcomes including both surgical site and periprosthetic infections, higher rates of early revision surgery, less improvement in pain/function, increase risk of persistent post discharge opioid use, longer stays in hospital and higher healthcare costs (Quinlan, Levy, Lobo, & Macintyre, 2021, Shadbolt et al., 2020, Adie et al., 2019). One in two Australian patients is prescribed an opioid in the year prior to joint replacement surgery (Inacio et al., 2018). On average over the last five years (2016-2021) TQEH completed approximately 140 TKR (both primary and revision operations) per year. Audit data from 2016-2021 at TQEH demonstrates that one in three (33%) of patients undergoing primary TKR (219/660) used preoperative opioid pain relief, with a median oral morphine equivalent daily dose (oMEDD) of 40mg. From 2016-2021 TQEH completed 49 revision TKRs with this patient population having a higher incidence of preoperative opioid use (24/49 or 48.9%) and the same median oral morphine equivalent daily dose of 40mg. This result underpins our decision to use oMEDDs of greater than or equal to 30mg for inclusion in the weaning protocol as detailed in the grant synopsis. This high incidence of opioid use within the health network likely has negative effects on patient outcomes as described above in literature examining other TKR patient populations. By designing and implementing a pathway for preoperative opioid weaning in patients presenting for TKR, we aim to improve outcomes without increasing preoperative pain. Opioid weaning in patients with chronic pain has been shown to be achievable with the majority of patients reporting the same or less pain. Implementing a slow, supervised taper from opioid analgesia poses minimal risk to patients (as opposed to rapid weaning), and as detailed below withdrawal symptoms will be monitored throughout the period of intervention. Should any patient experience withdrawal, they will be reverted to their previously tolerated dose and after a period of stabilisation be reintroduced to weaning at a lower intensity.
Interventions
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 approxima
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.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
- Unwilling to engage with intervention - Patient general practitioner unwilling to supervise opioid weaning process over course of study
Outcome results
None listed