Dataset Information

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

ABSTRACT:

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).

SUBMITTER: Pallapothu S

PROVIDER: S-EPMC9542329 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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

Pallapothu Sushmitha S Madden Kim K Adili Anthony A Krsmanovic Adrijana A Nowakowski Matilda M Packham Tara T Shoaib Sidra S Thabane Lehana L Tarride Jean-Eric JE Tushinski Daniel D Shanthanna Harsha H

Canadian journal of pain = Revue canadienne de la douleur 20221004 4

<h4>Background</h4>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.<h4> ...[more]

PMID: 36213524

Similar Datasets

Project description:BackgroundKnee 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.MethodsThis 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.DiscussionThe 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 registrationProspectively registered in Clinicaltrials.gov (NCT04968132).

Project description:ObjectivesEnhanced Recovery After Surgery (ERAS) programmes aim to improve care quality by optimising components of the care pathway and programmes for hip and knee replacement exist across the UK. However, there is variation in delivery and outcomes. This study aims to understand processes that influence implementation using the Consolidated Framework for Implementation Research (CFIR) to inform the design and delivery of services.DesignAn ethnographic study using observations and interviews with staff involved in service delivery. Data were analysed using a thematic analysis, followed by an abductive approach whereby themes were mapped onto the 31 constructs and 5 domains of the CFIR.SettingFour hospital sites in the UK delivering ERAS services for hip and knee replacement.Participants38 staff participated including orthopaedic surgeons, nurses and physiotherapists.ResultsResults showed 17 CFIR constructs influenced implementation in all five domains. Within 'intervention characteristics', participants thought ERAS afforded advantages over alternative solutions and guidance was adaptable. In the 'outer setting', it was felt ERAS should be tailored to patients and education used to empower them in their recovery. However, there were concerns about postdischarge support and tensions with primary care. Within the 'inner setting', effective multidisciplinary collaboration was achieved by transferring knowledge about patients along the care pathway and multidisciplinary working practices. ERAS was viewed as a 'message' that had to be communicated consistently. There were concerns about resources and high volumes of patients. Staff access to information varied. At the domain 'characteristics of individuals', knowledge and beliefs impacted on implementation. Within 'process', involving opinion leaders in development and 'champions' who acted as a central point of contact, helped to engage staff. Formal and informal feedback helped to develop services.ConclusionsFindings demonstrate successful implementation involves empowering patients to work towards recovery, providing postdischarge support and promoting successful multidisciplinary team working.

Project description:BackgroundEnhanced recovery after surgery (ERAS) protocols were rapidly adopted in many surgeries such as fast-track arthroplasty. The study aimed to investigate the impact of ERAS protocols on the clinical effect of total knee arthroplasty (TKA) via the midvastus approach.MethodsA total of 69 patients who underwent primary unilateral TKA via the midvastus approach from October 2018 to June 2019 were enrolled and randomly divided into two groups: ERAS group and Control group. The ERAS protocols were adopted for the ERAS group and consisted of pure juice drinking 2 h before the surgery, optimization of the preoperative anesthesia plan, phased use of tourniquets, and the use of tranexamic acid as well as a drug cocktail. The operative time, first postoperative walking time, first straight leg elevation time, postoperative hospitalization time, visual analogue scale score (VAS score), Hospital for Special Surgery score (HSS score), conventional Knee Society score (KSS), and knee range of motion (ROM) were used to assess the clinical effects in the two groups. All the included patients were followed up for 12 months.ResultsThere were no significant differences in the basic demographic information and operation time between the ERAS and Control groups (P > 0.05). The first postoperative walking time (2.11 ± 0.11 h) and first postoperative straight leg elevation time (6.14 ± 1.73 h) in the ERAS group were significantly earlier than those in the Control group (P < 0.001) and the postoperative hospitalization time was significantly shorter (3.11 ± 0.32 days). The postoperative mean VAS scores in both groups were significantly reduced compared with those before surgery (P < 0.001). The VAS scores for the ERAS group were significantly lower than those for the Control group at 1, 2, and 7 days after surgery (P < 0.001). The mean HSS scores, KSS, and knee ROM were significantly increased in both the ERAS and Control groups at 1, 3, 6, and 12 months after surgery (P < 0.001). In addition, the HSS scores, KSS, and knee ROM in the ERAS group were significantly higher than those in the Control group at 1 month after surgery (P < 0.001).ConclusionsERAS protocols improved the clinical effects of TKA via the midvastus approach, facilitating early out-of-bed activity and comfortable postoperative rehabilitation exercise, and further increasing patient satisfaction.Trial registrationClinicalTrials.gov Identifier: NCT04873544 .

Project description:IntroductionHip and knee replacement represents a significant burden to the UK healthcare system. 'Enhanced recovery' pathways have been introduced in the National Health Service (NHS) for patients undergoing hip and knee replacement, with the aim of improving outcomes and timely recovery after surgery. To support policymaking, there is a need to evaluate the cost-effectiveness of enhanced recovery pathways across jurisdictions. Our aim is to systematically summarise the published cost-effectiveness evidence on enhanced recovery in hip and knee replacement, both as a whole and for each of the various components of enhanced recovery pathways.Methods and analysisA systematic review will be conducted using MEDLINE, EMBASE, Econlit and the National Health Service Economic Evaluations Database. Separate search strategies were developed for each database including terms relating to hip and knee replacement/arthroplasty, economic evaluations, decision modelling and quality of life measures.We will extract peer-reviewed studies published between 2000 and 2017 reporting economic evaluations of preoperative, perioperative or postoperative enhanced recovery interventions within hip or knee replacement. Economic evaluations alongside cohort studies or based on decision models will be included. Only studies with patients undergoing elective replacement surgery of the hip or knee will be included. Data will be extracted using a predefined pro forma following best practice guidelines for economic evaluation, decision modelling and model validation.Our primary outcome will be the cost-effectiveness of enhanced recovery (entire pathway and individual components) in terms of incremental cost per quality-adjusted life year. A narrative synthesis of all studies will be presented, focussing on cost-effectiveness results, study design, quality and validation status.Ethics and disseminationThis systematic review is exempted from ethics approval because the work is carried out on published documents. The results of the review will be disseminated in a peer-reviewed academic journal and at conferences.Prospero registration numberCRD42017059473.

Dataset Information

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

Background

Objectives

Methods

Discussion

Publications

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

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