Prescription Opioids Higher Among Knee Arthroplasty Recipients Randomized to Inpatient Rehabilitation.
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ABSTRACT: Objective
To determine whether the purchase of prescription opioids was lower among people randomized to inpatient rehabilitation (IR) compared with those discharged directly home following total knee arthroplasty (TKA).Method
A secondary analysis of a previous clinical trial in which participants were randomized 3 to 5 days after -surgery to 10 days of IR and a home program or to a home program alone. The primary outcome for this secondary analysis was the purchase of opioid-based pain relief up to 10-weeks after surgery, which was captured via patient diaries. Between-group differences were analyzed using a χ2 test and relative risk (RR) (95% confidence interval [CI]). We report this outcome alongside the main outcomes observed at 10 weeks for the original study (6-minute walk test, index joint pain, and function) for context.Results
At 10 weeks, 158 participants were available for follow-up; 120 (76%) provided diaries, with 113 providing generic or brand names for the pain relief purchased. In the IR group, 60% (33/55) reported the purchase of opioid-based medications after discharge compared with 34% (20/58) in the home group (χ2 = 7.4; P = 0.007); thus, the risk of purchasing opioids for those in the IR group was almost double (RR, 1.7 [95% CI, 1.1-2.6]). No significant or meaningful between-group differences in index joint pain, function, or mobility were observed.Conclusion
Contrary to what was hypothesized, IR is a strong driver of opioid purchase after discharge from the hospital following TKA.
SUBMITTER: Naylor JM
PROVIDER: S-EPMC8363845 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function.This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required.The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty.U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.
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Project description:WHAT WE ALREADY KNOW ABOUT THIS TOPIC:WHAT THIS MANUSCRIPT TELLS US THAT IS NEW: BACKGROUND:: Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes. METHODS:The study included data on 88,830 total knee arthroplasties performed with a peripheral nerve block (Premier Healthcare Database 2013 to 2016). Multilevel multivariable regressions measured associations between use of liposomal bupivacaine and (1) inpatient opioid prescription (extracted from billing) and (2) length of stay, cost of hospitalization, as well as opioid-related complications. To reflect the difference between statistical and clinical significance, a relative change of -15% in outcomes was assumed to be clinically important. RESULTS:Overall, liposomal bupivacaine was used in 21.2% (n = 18,817) of patients that underwent a total knee arthroplasty with a peripheral nerve block. Liposomal bupivacaine use was not associated with a clinically meaningful reduction in inpatient opioid prescription (group median, 253 mg of oral morphine equivalents, adjusted effect -9.3% CI -11.1%, -7.5%; P < 0.0001) and length of stay (group median, 3 days, adjusted effect -8.8% CI -10.1%, -7.5%; P < 0.0001) with no effect on cost of hospitalization. Most importantly, liposomal bupivacaine use was not associated with decreased odds for opioid-related complications. CONCLUSIONS:Liposomal bupivacaine was not associated with a clinically relevant improvement in inpatient opioid prescription, resource utilization, or opioid-related complications in patients who received modern pain management including a peripheral nerve block.
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| S-EPMC5415445 | biostudies-literature
Project description:BackgroundRacial disparities in functional outcomes after total knee arthroplasty (TKA) exist. Whether differences in rehabilitation utilization contribute to these disparities remains to be investigated.MethodsAmong 8349 women enrolled in the prospective Women's Health Initiative cohort who underwent primary TKA between 2006 and 2013, rehabilitation utilization was determined through linked Medicare claims data. Postacute discharge destination (home, skilled nursing facility, and inpatient rehabilitation facility), facility length of stay, and number of home health physical therapy (HHPT) and outpatient physical therapy (OPPT) sessions were compared between racial groups.ResultsNon-Hispanic black women had worse physical function (median score, 65 vs 70) and higher likelihood of disability (13.2% vs 6.9%) than non-Hispanic white women before surgery. After TKA, black women were more likely to be discharged postacutely to an institutional facility (64.3% vs 54.5%) than white women, were more likely to receive HHPT services (52.6% vs 47.8%), and received more HHPT and OPPT sessions. After stratification by postacute discharge setting, the likelihood of receipt of HHPT or OPPT services was similar between racial groups. No significant difference in receipt of HHPT or OPPT services was found after use of propensity score weighting to balance health and medical characteristics indicating severity of need for physical therapy services.ConclusionRehabilitation utilization was generally comparable between black and white women who received TKA when accounting for need. There was no evidence of underutilization of post-TKA rehabilitation services, and thus disparities in post-TKA functional outcomes do not appear to be a result of inequitable receipt of rehabilitation care.
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Project description:Evaluate the effect of short-term use of precribed opioids on DNA methylation
2020-05-30 | GSE151485 | GEO
Project description:Importance:Even without evidence, rehabilitation practitioners continue to introduce new interventions to enhance the mobility outcomes for the increasing population with a recent total knee arthroplasty (TKA). Objective:To compare post-TKA functional mobility outcomes among 3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol. Design, Setting, and Participants:This randomized clinical trial included 4 study arms implemented in 15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017. Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA. A total of 505 patients were screened and 386 participants were enrolled. Patients provided informed consent and were randomly assigned to 1 of 4 groups. Blinding patients and treating therapists was not feasible owing to the nature of the intervention. Analysis was conducted under the modified intent-to-treat principle from October 2017 to May 2019. Interventions:The control group used a standard recumbent bike for 15 to 20 minutes each session. Interventions used 1 of 3 modalities for 15 to 20 minutes each session: (1) a body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation. Main Outcomes and Measures:Outcomes included the Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test. Outcomes were measured at baseline, monthly, and on discharge from outpatient therapy. Results:Data from 363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women) were included in the final analysis, including 92 participants randomized to the control group, 91 participants randomized to the treadmill group, 90 participants randomized to the neuromuscular stimulation device group, and 90 participants randomized to the combination intervention group. Activity Measure for Post-acute Care scores at discharge were similar across groups, ranging from 61.1 to 61.3 (P?=?.99) with at least 9.0 points improvement (P?=?.80) since baseline. The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P?=?.60). Conclusions and Relevance:This randomized clinical trial found no statistically or clinically significant differences in outcomes across the 4 arms. Because outcomes were similar among arms, clinicians should instead consider relative cost in tailoring TKA rehabilitation. Trial Registration:ClinicalTrials.gov Identifier: NCT02426190.
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Project description:Ischaemic preconditioning is a method of protecting tissue against ischaemia-reperfusion injury. It is an innate protective mechanism that increases a tissue's tolerance to prolonged ischaemia when it is first subjected to short burst of ischaemia and reperfusion. It is thought to provide this protection by increasing the tissue's tolerance to ischaemia, therby reducing oxidative stress, inflammation and apoptosis in the preconditioned tissue. We used microarrays to investigate the genomic response induced by ischaemic preconditioning in muscle biopsies taken from the operative leg of total knee arthroplasty patients in order to gain insight into the ischaemic preconditioning mechanism. Patients undergoing primary knee arthroplasty were randomised to control and treatment (ischaemic preconditioning) groups. Patients in the treatment group received a preconditioning stimulus immediately prior to surgery. The ischaemic preconditioning stimulus consisted of three five-minute periods of tourniquet insufflation on the lower operative limb, interrupted by five minute periods of reperfusion. All patients had a tourniquet applied to the lower limb after the administration of spinal anaesthesia, as per normal protocol for knee arthroplasty surgery. Muscle biopsies were taken from the quadriceps muscle of the operative knee at the immediate onset of surgery (T0) and at 1 hour into surgery (T1). Total RNA was extracted from biospies of four control and four treatment patients and hybridised to the Affymetrix Human U133 2.0 chip.
2010-04-12 | E-GEOD-21164 | biostudies-arrayexpress
Project description:ImportanceRecent publication of the largest trials to date investigating rehabilitation after total knee arthroplasty (TKA) necessitate an updated evidence review.ObjectiveTo determine whether inpatient or clinic-based rehabilitation is associated with superior function and pain outcomes after TKA compared with any home-based program.Data sourcesMEDLINE, Embase, CINAHL, and PubMed were searched from inception to November 5, 2018. Search terms included knee arthroplasty, randomized controlled trial, physiotherapy, and rehabilitation.Study selectionPublished randomized clinical trials of adults who underwent primary unilateral TKA and commenced rehabilitation within 6 postoperative weeks in which those receiving postacute inpatient or clinic-based rehabilitation were compared with those receiving a home-based program.Data extraction and synthesisTwo reviewers extracted data independently and assessed data quality and validity according to the PRISMA guidelines. Data were pooled using a random-effects model. Data were analyzed from June 1, 2015, through June 4, 2018.Main outcomes and measuresPrimary outcomes were mobility (6-minute walk test [6MWT]) and patient-reported pain and function (Oxford knee score [OKS] or Western Ontario and McMaster Universities Osteoarthritis Index) reported at 10 to 12 postoperative weeks. The GRADE assessment (Grading of Recommendations, Assessment, Development, and Evaluation) was applied to the primary outcomes.ResultsFive unique studies involving 752 unique participants (451 [60%] female; mean [SD] age, 68.3 [8.5] years) compared clinic- and home-based rehabilitation, and 1 study involving 165 participants (112 [68%] female; mean [SD] age, 66.9 [8.0] years) compared inpatient and home-based rehabilitation. Low-quality evidence showed no clinically important difference between clinic- and home-based programs for mobility at 10 weeks (6MWT favoring home program; mean difference [MD], -11.89 m [95% CI, -35.94 to 12.16 m]) and 52 weeks (6MWT favoring home program; MD, -25.37 m [95% CI, -47.41 to -3.32 m]). Moderate-quality evidence showed no clinically important difference between clinic- and home-based programs for patient-reported pain and function at 10 weeks (OKS MD, -0.15 [95% CI, -0.35 to 0.05]) and 52 weeks (OKS MD, 0.10 [95% CI, -0.14 to 0.34]).Conclusions and relevanceBased on low- to moderate-quality evidence, no superiority of clinic-based or inpatient programs compared with home-based programs was found in the early subacute period after TKA. This evidence suggests that home-based rehabilitation is an appropriate first line of therapy after uncomplicated TKA for patients with adequate social supports.
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Project description:Little information exists to support that patients care about flexion beyond what is needed to perform activities of daily living (ADL) after Total knee arthroplasty (TKA). The purpose of this study was to investigate if the achievement of a higher degree of knee flexion after TKA would result in a better patient perceived outcome.The study is a randomized, double-blinded, controlled trial in which 36 patients (mean age: 67.2 yrs) undergoing one-stage bilateral TKA randomly received a standard cruciate-retaining (CR) TKA in one knee and a high-flex posterior-stabilized (PS) TKA in the contra lateral knee. At follow-up ROM, satisfaction, pain, "feel" of the knee and the abilities in daily activities were assessed.At 1-year follow-up we found an expected significantly higher degree of knee flexion of 7° in the high-flex knees (p = 0.001). The high-flex TKA's showed a mean active flexion of 121°. In both TKA's the median VAS pain score was 0, the median VAS satisfaction score was 9, and the median VAS score of the patient "feel" of the knee was 9 at 1-year follow-up. Further, there were no significant differences between the knees in the performance of daily activities.As expected the high-flex TKA showed increased knee flexion, but no significant differences in the patient perceived outcomes were found. This suggests little relevance to the patients of the difference in knee flexion - when flexion is of this magnitude - as pain free ROM and high patient satisfaction were achieved with both TKA's.ClinicalTrials.gov: NCT00294528.
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