Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty.

BACKGROUND: Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. METHODS: This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo usual care. The primary outcomes of this pilot trial are to assess the feasibility of participant recruitment, retention, and adherence to the interventions, and key secondary outcomes are persisting pain and opioid use. DISCUSSION: The results of this trial will determine the feasibility of conducting a definitive trial for the implementation of a multicomponent pain pathway to improve pain control and reduce harms using a coordinated approach, while keeping an emphasis on patient centred care and shared decision making. TRIAL REGISTRATION: Prospectively registered in Clinicaltrials.gov (NCT04968132).

Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial.

BACKGROUND: Total knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate partial knee replacements, increasing accuracy and precision. This trial will investigate the feasibility and assess clinical outcomes for a larger definitive trial. METHODS: This is a protocol for an ongoing parallel randomized pilot trial of 64 patients with uni- or bicompartmental knee arthritis. Patients are randomized to either receive robot-assisted partial knee arthroplasty or manual total knee arthroplasty. The primary outcome of this pilot is investigating the feasibility of a larger trial. Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post-surgical pain, re-operations, resource utilization and cost-effectiveness, health-related quality of life, radiographic alignment, knee kinematics during walking gait, and complications up to 24 months post-surgery. DISCUSSION: The RoboKnees pilot study is the first step in determining the outcome of robot-assisted partial knee replacements. Conclusions from this study will be used to design future large-scale trials. This study will inform surgeons about the potential benefits of robot-assisted partial knee replacements. TRIAL REGISTRATION: This study was prospectively registered on clinicaltrials.gov (identifier: NCT04378049) on 4 May 2020, before the first patient was randomized.

The Continuous Fragility Index of Statistically Significant Findings in Randomized Controlled Trials That Compare Interventions for Anterior Shoulder Instability.

BACKGROUND: Evidence-based care relies on robust research. The fragility index (FI) is used to assess the robustness of statistically significant findings in randomized controlled trials (RCTs). While the traditional FI is limited to dichotomous outcomes, a novel tool, the continuous fragility index (CFI), allows for the assessment of the robustness of continuous outcomes. PURPOSE: To calculate the CFI of statistically significant continuous outcomes in RCTs evaluating interventions for managing anterior shoulder instability (ASI). STUDY DESIGN: Meta-analysis; Level of evidence, 2. METHODS: A search was conducted across the MEDLINE, Embase, and CENTRAL databases for RCTs assessing management strategies for ASI from inception to October 6, 2022. Studies that reported a statistically significant difference between study groups in ≥1 continuous outcome were included. The CFI was calculated and applied to all available RCTs reporting interventions for ASI. Multivariable linear regression was performed between the CFI and various study characteristics as predictors. RESULTS: There were 27 RCTs, with a total of 1846 shoulders, included. The median sample size was 61 shoulders (IQR, 43). The median CFI across 27 RCTs was 8.2 (IQR, 17.2; 95% CI, 3.6-15.4). The median CFI was 7.9 (IQR, 21; 95% CI, 1-22) for 11 studies comparing surgical methods, 22.6 (IQR, 16; 95% CI, 8.2-30.4) for 6 studies comparing nonsurgical reduction interventions, 2.8 for 3 studies comparing immobilization methods, and 2.4 for 3 studies comparing surgical versus nonsurgical interventions. Significantly, 22 of 57 included outcomes (38.6%) from studies with completed follow-up data had a loss to follow-up exceeding their CFI. Multivariable regression demonstrated that there was a statistically significant positive correlation between a trial's sample size and the CFI of its outcomes (r = 0.23 [95% CI, 0.13-0.33]; P < .001). CONCLUSION: More than a third of continuous outcomes in ASI trials had a CFI less than the reported loss to follow-up. This carries the significant risk of reversing trial findings and should be considered when evaluating available RCT data. We recommend including the FI, CFI, and loss to follow-up in the abstracts of future RCTs.

Perceptions in orthopedic surgery on the use of cannabis in treating pain: a survey of patients with spine pain (POSIT Spine).

BACKGROUND: Back pain is the leading cause of disability worldwide. Despite guidelines discouraging opioids as first-line treatment, opioids remain the most prescribed drugs for back pain. There is renewed interest in exploring the potential medical applications of cannabis, and with the recent changes in national legislation there is a unique opportunity to investigate the analgesic properties of cannabis. METHODS: This was a multi-center survey-based study examining patient perceptions regarding cannabis for spine pain. We included patients presenting with back or neck pain to one of three Orthopedic clinics in Ontario. Our primary outcome was perceived effect of cannabis on back pain, while secondary outcomes were perceptions regarding potential applications and barriers to cannabis use. RESULTS: 259 patients participated in this study, 35.3% (90/255) stating they used cannabis medically. Average pain severity was 6.5/10 ± 0.3 (95% CI 6.2-6.8). Nearly three-quarters were prescribed opioids (73.6%, 148/201), with oxycodone/oxycontin (45.9% 68/148) being the most common, and almost half of (49.3%, 73/148) had used an opioid in the last week. Patients estimated cannabis could treat 54.3% ± 4.0 (95% CI 50.3-58.3%) of their spine pain and replace 46.2% ± 6. 6 (95% CI 39.6-52.8%) of their current analgesics. Age (ß = - 0.3, CI - 0.6-0.0), higher pain severity (ß = 0.4, CI 0.1-0.6) and previous cannabis use (ß = 14.7, CI 5.1-24.4) were associated with a higher perceived effect of cannabis. Patients thought cannabis would be beneficial to treat pain (129/146, 88.4%), and reduce (116/146, 79.5%) or eliminate opioids (102/146, 69.9%). Not considering using cannabis for medical purposes (65/150, 43.3%) was the number one reported barrier. CONCLUSIONS: Patients estimated medical cannabis could treat more than half of their spine pain, with one in three patients already using medical cannabis. 79% of patients also believe cannabis could reduce opioid usage. This data will help support more research into cannabis for musculoskeletal pain.

Feasibility of pain informed movement program for people with knee osteoarthritis.

Objective: To establish the feasibility of an intervention consisting of neuromuscular exercise, mind-body techniques, and pain neuroscience education (PNE), referred to as Pain Informed Movement in people with knee Osteoarthritis (KOA). This program has the potential to improve our understanding of intrinsic pain modulation and its role in the management of chronic pain. Methods: This was a single-arm feasibility trial with a nested qualitative component. Primary outcome: complete follow-up. Inclusion criteria: age ≥40 years, KOA clinical diagnosis or meeting KOA NICE criteria, and pain intensity ≥3/10. The program consisted of 8-week in-person and at-home exercise sessions. PNE and mind-body techniques were provided as videos and integrated into the exercise sessions. Participants completed questionnaires and physical assessments including blood draws at baseline and program completion. Secondary feasibility outcomes: acceptability of the intervention, burden, rates of recruitment, compliance and adherence, and adverse events. A priori success criteria were identified. Participants were invited to an online focus group. Results: 19 participants were enrolled, with a complete follow-up rate of 74% (mean age 63.3 years (SD 10.5), 73% female), indicating modifications were necessary to proceed. All other success criteria were met. The focus groups revealed that the video content pertaining to the mind-body techniques would benefit from on screen demonstrations. Conclusion: The Pain Informed Movement program is deemed feasible, with minor modifications needed to proceed. A pilot two-arm RCT will be conducted to establish the feasibility and explore potential effects of Pain Informed Movement compared to conventional neuromuscular exercise and standard OA education.

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial.

Objective: Conservative pain management strategies for knee osteoarthritis (KOA) have limited effectiveness and do not employ a pain-mechanism informed approach. Pain Informed Movement is a novel intervention combining mind-body techniques with neuromuscular exercise and pain neuroscience education (PNE), aimed at improving endogenous pain modulation. While the feasibility and acceptability of this program has been previously established, it now requires further evaluation in comparison to standard KOA care. Design: This protocol describes the design of a pilot two-arm randomized controlled trial (RCT) with an embedded qualitative component. The primary outcome is complete follow-up rate. With an allocation ratio of 1:1, 66 participants (33/arm) (age ≥40 years, KOA diagnosis or meeting KOA NICE criteria, and pain intensity ≥3/10), will be randomly allocated to two groups that will both receive 8 weeks of twice weekly in-person exercise sessions. Those randomized to Pain Informed Movement will receive PNE and mind-body technique instruction provided initially as videos and integrated into exercise sessions. The control arm will receive neuromuscular exercise and standard OA education. Assessment will include clinical questionnaires, physical and psychophysical tests, and blood draws at baseline and program completion. Secondary outcomes are program acceptability, burden, rate of recruitment, compliance and adherence, and adverse events. Participants will be invited to an online focus group at program completion. Conclusion: The results of this pilot RCT will serve as the basis for a larger multi-site RCT aimed at determining the program's effectiveness with the primary outcome of assessing the mediating effects of descending modulation on changes in pain.

Preoperative assessment of postoperative delirium: a cross-sectional study of patients and anesthesiologists in Canada.

PURPOSE: We sought to evaluate 1) patient- and anesthesiologist-reported rates of postoperative delirium (POD) risk discussion during preoperative meetings, 2) patients' and anesthesiologists' ratings of the importance of POD, and 3) predictors of patient-reported discussion of POD risk during preoperative meetings. METHODS: In this multicentre two-part cross-sectional survey study, patients ≥ 65 yr scheduled to undergo elective noncardiac surgery completed a five-minute survey after preoperative anesthesia consultation. Patients were asked about their perception of POD importance, and whether they discussed or were assessed for POD risk. Anesthesiologists were surveyed using self-administered surveys circulated via institutional email lists. Anesthesiologists were asked about the frequency of POD risk assessment and discussion in older adults, tools used, and perception of POD-screening barriers. RESULTS: Four hundred and twelve (of 510 approached) patients (50% male; mean age, 73 yr) and 267 anesthesiologists (of 1,205 invited via e-mail) participated in this study conducted in five Canadian hospitals. Postoperative delirium screening and discussion was reported by 88/412 (22%) patients and 229/267 (86%) anesthesiologists. Postoperative delirium was rated as "somewhat-extremely" important by 64% of patients. A previous history of delirium, higher education, the number of daily medications, and longer surgical duration were associated with POD discussion. On average, anesthesiologists rated the importance of POD at 8/10, and 42% ranked "patient risk factors" as the top reason prompting discussion. CONCLUSION: The combined evaluation of patients' and anesthesiologists' perspectives provides valuable information on preoperative POD screening and risk assessment, and highlights areas for improvement in the current practice. Most factors we identified to be associated with higher odds of POD discussion are recognized risk factors of POD.

RéSUMé: OBJECTIF: Nous avons cherché à évaluer 1) les taux de discussion concernant le risque de delirium postopératoire (DPO) déclarés par les patient·es et les anesthésiologistes lors des rencontres préopératoires, 2) les évaluations des patient·es et des anesthésiologistes de l'importance de DPO, et 3) les prédicteurs d'une discussion telle que rapportée par les patient·es sur le risque de DPO pendant les rencontres préopératoires. MéTHODE: Dans ce sondage transversal multicentrique en deux parties, les patient·es ≥ 65 ans devant subir une chirurgie non cardiaque non urgente ont rempli un sondage de cinq minutes après la consultation d'anesthésie préopératoire. Les patient·es ont été interrogé·es sur leur perception de l'importance du DPO et si leur risque de DPO avait été discuté ou évalué. Des sondages auto-administrés ont été distribués aux anesthésiologistes via les listes de courriels institutionnelles. Ce sondage interrogeait les anesthésiologistes quant à la fréquence de l'évaluation et de la discussion des risques de DPO chez les personnes âgées, aux outils utilisés et à la perception des obstacles au dépistage de DPO. RéSULTATS: Quatre cent douze (des 510 personnes approchées) patient·es (50 % d'hommes; âge moyen, 73 ans) et 267 anesthésiologistes (sur 1205 invité·es par courriel) ont participé à cette étude menée dans cinq hôpitaux canadiens. Le dépistage et la discussion sur le delirium postopératoire ont été signalés par 88/412 (22 %) des patient·es et 229/267 (86 %) des anesthésiologistes. Le delirium postopératoire a été jugé « assez ­ extrêmement ¼ important par 64 % des patient·es. Des antécédents de delirium, des études supérieures, le nombre de médicaments quotidiens et une durée chirurgicale plus longue ont été associés à la discussion sur le DPO. En moyenne, les anesthésiologistes ont évalué l'importance du DPO à 8/10, et 42 % ont classé les « facteurs de risque liés au/à la patient·e ¼ comme la principale raison suscitant la discussion. CONCLUSION: L'évaluation combinée des points de vue des patient·es et des anesthésiologistes fournit des informations précieuses sur le dépistage préopératoire des DPO et l'évaluation des risques, et met en évidence les domaines à améliorer dans la pratique actuelle. La plupart des facteurs que nous avons identifiés comme étant associés à des probabilités plus élevées de discussion sur le DPO sont des facteurs de risque reconnus de DPO.

The role of preoperative opioid use in shoulder surgery-A systematic review.

Background: Emerging evidence suggests preoperative opioid use may increase the risk of negative outcomes following orthopedic procedures. This systematic review evaluated the impact of preoperative opioid use in patients undergoing shoulder surgery with respect to preoperative clinical outcomes, postoperative complications, and postoperative dependence on opioids. Methods: EMBASE, MEDLINE, CENTRAL, and CINAHL were searched from inception to April, 2021 for studies reporting preoperative opioid use and its effect on postoperative outcomes or opioid use. The search, data extraction and methodologic assessment were performed in duplicate for all included studies. Results: Twenty-one studies with a total of 257,301 patients were included in the final synthesis. Of which, 17 were level III evidence. Of those, 51.5% of the patients reported pre-operative opioid use. Fourteen studies (66.7%) reported a higher likelihood of opioid use at follow-up among those used opioids preoperatively compared to preoperative opioid-naïve patients. Eight studies (38.1%) showed lower functional measurements and range of motion in opioid group compared to the non-opioid group post-operatively. Conclusion: Preoperative opioid use in patients undergoing shoulder surgeries is associated with lower functional scores and post-operative range of motion. Most concerning is preoperative opioid use may predict increased post-operative opioid requirements and potential for misuse in patients. Level of evidence: Level IV, Systematic review.

The reporting quality and transparency of orthopaedic studies using Bayesian analysis requires improvement: A systematic review.

Background: Bayesian methods are being used more frequently in orthopaedics. To advance the use and transparent reporting of Bayesian studies, reporting guidelines have been recommended. There is currently little known about the use or applications of Bayesian analysis in orthopedics including adherence to recommended reporting guidelines. The objective is to investigate the reporting of Bayesian analysis in orthopedic surgery studies; specifically, to evaluate if these papers adhere to reporting guidelines. Methods: We searched PUBMED to December 2nd, 2020. Two reviewers independently identified studies and full-text screening. We included studies that focused on one or more orthopaedic surgical interventions and used Bayesian methods. Results: After full-text review, 100 articles were included. The most frequent study designs were meta-analysis or network meta-analysis (56%, 95% CI 46-65) and cohort studies (25%, 95% CI 18-34). Joint replacement was the most common subspecialty (33%, 95% CI 25-43). We found that studies infrequently reported key concepts in Bayesian analysis including, specifying the prior distribution (37-39%), justifying the prior distribution (18%), the sensitivity to different priors (7-8%), and the statistical model used (22%). In contrast, general methodological items on the checklists were largely well reported. Conclusions: There is an opportunity to improve reporting quality and transparency of orthopaedic studies using Bayesian analysis by encouraging adherence to reporting guidelines such as ROBUST, JASP, and BayesWatch. There is an opportunity to better report prior distributions, sensitivity analyses, and the statistical models used.

Clinical practice guidelines: The good, the bad, and the ugly.

Clinical practices guidelines (CPGs) play a fundamental role in improving healthcare and patients' outcomes by helping clinicians make the best evidence-based decisions for their patients in a time-efficient manner. By following the available methods and criteria to create trustworthy CPGs, panel members can develop high-quality guidelines. However, despite the improvements over the years, CPGs are still subjected to biases and limitations, with conflicts of interest being the ugliest problem GCPs must face. In this review, we discuss the main characteristics of clinical practice guidelines, their pros and cons, and the future challenges they need to overcome.

A systematic review of clinical outcomes for outpatient vs. inpatient shoulder arthroplasty.

Background: Outpatient shoulder arthroplasty is growing in popularity as a cost-effective and potentially equally safe alternative to inpatient arthroplasty. The aim of this study was to investigate literature relating to outpatient shoulder arthroplasty, looking at clinical outcomes, complications, readmission, and cost compared to inpatient arthroplasty. Methods: We conducted a systematic review of Medline, Embase and Cochrane Library databases from inception to 6 April 2020. Methodological quality was assessed using MINORS and GRADE criteria. Results: We included 17 studies, with 11 included in meta-analyses and 6 in narrative review. A meta-analysis of hospital readmissions demonstrated no statistically significant difference between outpatient and inpatient cohorts (OR = 0.89, p = 0.49). Pooled post-operative complications identified decreased complications in those undergoing outpatient surgery (OR = 0.70, p = 0.02). Considerable cost saving of between $3614 and $53,202 (19.7-69.9%) per patient were present in the outpatient setting. Overall study quality was low and presented a serious risk of bias. Discussion: Shoulder arthroplasty in the outpatient setting appears to be as safe as shoulder arthroplasty in the inpatient setting, with a significant reduction in cost. However, this is based on low quality evidence and high risk of bias suggests further research is needed to substantiate these findings.

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): A feasibility randomized controlled trial in knee replacement patients.

Background: Total knee arthroplasties are the second most common surgery in Canada. Most patients recover well, but 20% or more still suffer from persistent pain and opioid use. Though opioids are an important part of perioperative pain management, their potential for long-term adverse effects is well recognized. Limiting opioids may be insufficient to overcome the issue of opioid overuse. Pain and opioid use are highly linked, so an effective alternative needs to address both issues. Objectives: The principal objective of this pilot trial is to assess the feasibility. The clinical objectives are to determine the effects of a multicomponent care pathway on opioid-free pain control, persisting pain and opioid use, functional knee outcomes, quality of life, and return to function. Methods: We will include adult patients scheduled for primary elective total knee arthroplasty. Patients in the intervention group will undergo a multicomponent intervention pathway that will be facilitated by an intervention coordinator linking each patient and their surgical/ perioperative team. The interventional pathway will include (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation using cognitive behavioral skills, (3) personalized postdischarge analgesic prescriptions, and (4) continued support for pain control and recovery up to 8 weeks. Patients in the control group will receive the usual care at their institution. Discussion: The overarching goal is to implement and evaluate a coordinated approach to clinical care to improve pain control and reduce harms, with an emphasis on patient-centered care and shared decision making.Trial Registration Number: NCT04968132 (informed consent/ research ethics board statement).

Contexte: L'arthroplastie totale du genou est la deuxième chirurgie la plus courante au Canada. La plupart des patients se rétablissent bien, mais au moins 20 pour cent d'entre eux souffrent encore de douleur persistante et de consommation d'opioïdes. Bien que les opioïdes soient un élément important de la prise en charge périopératoire de la douleur, leur potentiel d'effets indésirables à long terme est bien reconnu. La limitation des opioïdes peut être insuffisante pour surmonter le problème de la surconsommation d'opioïdes. La douleur et la consommation d'opioïdes sont étroitement liées, de sorte qu'une option de rechange efficace doit s'attaquer à ces deux problèmes.Objectifs: L'objectif principal de cet essai pilote est d'évaluer la faisabilité. Les objectifs cliniques sont de déterminer les effets d'une voie de soins à composantes multiples sur la maitrise de la douleur sans opioïdes, la douleur persistante et la consommation d'opioïdes, les résultats fonctionnels du genou, la qualité de vie et le retour à la fonction.Méthodes: Nous inclurons les patients adultes devant subir une arthroplastie primaire totale élective du genou. Les patients du groupe d'intervention seront soumis à une voie d'intervention à composantes multiples qui sera facilitée par un coordonnateur d'intervention reliant chaque patient et son équipe chirurgicale/périopératoire. La voie d'intervention comprendra (1) une éducation préopératoire sur la douleur et la consommation d'opioïdes, (2) la détermination et l'atténuation des risques préopératoires à l'aide de compétences comportementales cognitives, (3) des prescriptions analgésiques personnalisées après la sortie, et (4) un soutien continu pour la maîtrise de la douleur et la récupération pendant une période allant jusqu'à huit semaines. Les patients du groupe témoin recevront les soins habituels à leur établissement.Discussion: L'objectif global est de mettre en œuvre et d'évaluer une approche coordonnée des soins cliniques afin d'améliorer la maitrise de la douleur et réduire les méfaits, en mettant l'accent sur les soins centrés sur le patient et la prise de décision partagée. Numéro d'enregistrement de l'essai : NCT04968132 (consentement éclairé/déclaration du comité d'éthique de la recherche).

Reduction of opioid use after orthopedic surgery: a scoping review.

BACKGROUND: The opioid epidemic is one of the biggest public health crises of our time, and overprescribing of opioids after surgery has the potential to lead to long-term use. The purpose of this review was to identify and summarize the available evidence on interventions aimed at reducing opioid use after orthopedic surgery. METHODS: We searched CENTRAL, Embase and Medline from inception until August 2019 for studies comparing interventions aimed at reducing opioid use after orthopedic surgery to a control group. We recorded demographic data and data on intervention success, and recorded or calculated percent opioid reduction compared to control. RESULTS: We included 141 studies (20 963 patients) in the review, of which 113 (80.1%) were randomized controlled trials (RCTs), 6 (4.3%) were prospective cohort studies, 16 (11.4%) were retrospective cohort studies, 5 (3.6%) were case reports, and 1 (0.7%) was a case series. The majority of studies (95 [67.4%]) had a follow-up duration of 2 days or less. Interventions included the use of local anesthetics and/or nerve blocks (42 studies [29.8%]), nonsteroidal anti-inflammatory drugs (31 [22.0%]), neuropathic pain medications (9 [6.4%]) and multimodal analgesic combinations (25 [17.7%]. In 127 studies (90.1%), a significant decrease in postoperative opioid consumption compared to the control intervention was reported; the median opioid reduction in these studies was 39.7% (range 5%-100%). Despite these reductions in opioid use, the effect on pain scores and on incidence of adverse effects was inconsistent. CONCLUSION: There is a large body of evidence from randomized trials showing the promise of a variety of interventions for reducing opioid use after orthopedic surgery. Rigorously designed RCTs are needed to determine the ideal interventions or combination of interventions for reducing opioid use, for the good of patients, medicine and society.