Continuous Local Infiltration Analgesia for Pain Control After Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Trials

A total knee arthroplasty (TKA) has always been associated with moderate to severe pain. As more research is conducted on the use of continuous local infiltration analgesia (CLIA) to manage pain after a TKA, it is necessary to reassess the efficacy and safety of the TKA method. The purpose of this systematic review and meta-analysis of randomized controlled trials was to evaluate the efficacy and safety of pain control of CLIA versus placebo after a TKA.In January 2015, a systematic computer-based search was conducted in the Medline, Embase, PubMed, CENTRAL (Cochrane Controlled Trials Register), Web of Science, Google database, and Chinese Wanfang databases. This systematic review and meta-analysis were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement criteria. The primary endpoint was the visual analog scale score after a TKA with rest or mobilization at 24, 48, and 72 hours, which represents the effect of pain control after TKA. The complications of infection, nausea, and whether it prolonged wound drainage were also compiled to assess the safety of CLIA. RevMan 5.30 software was used for the meta-analysis. After testing for publication bias and heterogeneity across studies, data were aggregated for random-effects modeling when necessary.Ten studies involving 735 patients met the inclusion criteria. The meta-analysis revealed that continuous infusion analgesia provided better pain control with rest at 24 hours (mean difference [MD] −12.54, 95% confidence interval [CI] −16.63 to 8.45), and with mobilization at 24 hours (MD −18.27, 95% CI −27.52 to 9.02) and 48 hours (MD −14.19, 95% CI −21.46 to 6.93). There was no significant difference with respect to the visual analog scale score at 48 hours (MD −6.15, 95% CI −13.51 to 1.22, P = 0.10) and 72 hours (MD −3.63, 95% CI −10.43 to 3.16, P = 0.29) with rest and at 72 hours with mobilization (MD −4.25, 95% CI −16.27 to 7.77, P = 0.49). However, CLIA increased the rate of infection (relative risk [RR] 3.16, 95% CI 1.18–8.50, P = 0.02) and the rate of nausea or vomiting (RR 0.60, 95% CI 0.37–0.96, P = 0.03). There were no significant differences in the length of hospital stay (MD −0.34, 95% CI −1.09 to 0.42, P = 0.38), deep venous thrombosis (RR 1.02, 95% CI 0.30 to 1.41, P = 0.99), or duration of surgery (MD 1.20, 95% CI −4.59 to 6.98, P = 0.69).On the basis of the current meta-analysis, CLIA was more efficacious for reducing postoperative pain than the placebo at 24 hours with rest and at 24 and 48 hours with mobilization, but it increased the risk of infection. However, CLIA did not prolong the length of hospital stay or the duration of surgery. There was also a higher heterogeneity of different analgesic drugs mixed and a high risk of selection bias in this analysis; therefore, more high-quality randomized controlled trials with standardized CLIA are necessary for proper comparisons of this technique with other methods.     

A Randomized Trial of Acute Normovolemic Hemodilution Compared to Preoperative Autologous Blood Donation in Total Knee Arthroplasty

The value of acute normovolemic hemodilution (ANH) compared to preoperative autologous blood donation (PAD) in elective surgery is controversial. We therefore conducted a prospective, randomized study to compare these techniques in patients undergoing total knee arthroplasty. ANH patient underwent up to 4 units phlebotomy or to target hematocrit level of 28% after induction of anesthesia. PAD patients were asked to donate 1 (unilateral) or 2 (bilateral, revisions) units before admission. Mean baseline hematocrit levels were not different between ANH and PAD patients (40.6±4.1 vs. 38.4±3.4, p = 0.09). Eight (73%) of 11 patients undergoing bilateral revision procedures received a total of 22 allogeneic blood units, whereas only 3 (14%) of 21 patients undergoing primary, unilateral procedures received a total of 3 allogeneic units (p = 0.002). We found no differences in allogeneic blood transfusions between ANH and PAD cohorts for all (n = 32) patients (1.0±1.2 vs. 0.6±1.4, p = 0.45), for unilateral knee (n = 21) replacement (0.25±0.46 vs. 0.08±0.28, p = 0.29), or for bilateral/revision (n = 11) procedures (1.9±1.3 vs. 2.5±1.9, p = 0.53). We conclude that each technique is equally effective in reducing allogeneic blood exposure. Patients undergoing revision or bilateral knee arthroplasties require adjunctive therapy to autologous blood procurement to further reduce allogeneic blood exposure.     

Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial

BackgroundGiven the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly).ObjectivesThis study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial.MethodsThe trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life–5 Dimensions–5 Level visual analogue scale at 12 weeks.ResultsMACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes).ConclusionsYoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408).     

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy

BackgroundSubclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.ObjectivesThe aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.MethodsThe randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.ResultsSeven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (P_interaction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).ConclusionsApixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649)     

The Analgesic Effect of Oxygen in Suspected Acute Myocardial Infarction: A Substudy of the DETO2X-AMI Trial

Objectives

In this substudy of the DETO2X-AMI (An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction) trial, the authors aimed to assess the analgesic effect of moderate-flow oxygen supplementation in patients with suspected acute myocardial infarction (AMI) treated with percutaneous coronary intervention (PCI) and to study the effect of oxygen supplementation on the use of opiates and sedatives during PCI.

Effects of a Foot Pump on the Incidence of Deep Vein Thrombosis After Total Knee Arthroplasty in Patients Given Edoxaban: A Randomized Controlled Study

We conducted a randomized clinical trial to compare the effectiveness of the A-V Impulse System foot pump for reducing the incidence of deep-vein thrombosis (DVT) after total knee arthroplasty (TKA) in patients under edoxaban thromboprophylaxis.Patients undergoing primary TKA at our institution between September 2013 and March 2015 were enrolled after obtaining informed consent. The patients were randomized to use the foot pump (n = 58) and not to use the foot pump (n = 62). Both groups were given prophylactic edoxaban. Primary outcomes were any DVT as detected by bilateral ultrasonography up to postoperative day 10 (POD10) and pulmonary embolism (PE) up to POD28. The safety outcomes were bleeding and death of any cause up to POD28. Plasma D-dimer levels were measured before TKA and on POD10 after TKA. Immunoglobulin G (IgG)-class anti-PF4/heparin antibodies were measured using an IgG-specific enzyme-linked immunosorbent assay.The incidences of any DVT up to POD28 were 31.0% and 17.7% in patients with or without the foot pump, respectively. The incidences of major bleeding up to POD28 were 5.1% and 4.8% in patients with or without the foot pump, respectively. Foot pump use did not significantly reduce the incidence of DVTs in patients undergoing TKA under edoxaban thromboprophylaxis. Although seroconversion of anti-PF4/heparin antibodies was confirmed in one-fourth of patients, the seroconversion rates did not differ between patients with (20.7%) or without (25.8%) foot pump use.This study shows that the A-V Impulse system foot pump did not affect the incidence of DVT under edoxaban thromboprophylaxis in patients undergoing TKA. Seroconversion of anti-PF4/heparin antibodies was detected in a significant number of patients who underwent TKA under antithrombotic prophylaxis using edoxaban.     

Haemophilic; Arthropathy: Assessment of Quality of Life After Total Knee Arthroplasty

The goal of this study was to examine how the known effects of total knee arthroplasty (TKA) on clinical outcome parameters translate into improved quality of life, as measured with validated condition-specific and generic questionnaires (Knee Society Score, WOMAC, SF-12, transition questions), addressing physical, mental and social health. Eleven patients (13 knees) undergoing TKA from 1986 to 1994, with the diagnosis of severe haemophilic arthropathy of the knee, were followed-up over a 4-year period on average. TKA was found to reduce the burden of disease to levels similar to patients with osteoarthritis undergoing hip arthroplasty. Clinical and functional improvement after TKA translated into a substantial and significant increase in quality of life and patient satisfaction, found in objective as well as in patient-perceived measures. However, the physical functional ability did not reach the same level as in the corresponding population not affected by haemophilia, due to residual symptoms and impairment of other joints. Received: 30 September 1998 / Accepted: 17 March 1999     

Effect of Comprehensive Behavioral and Exercise Intervention on Physical Function and Activity Participation After Total Knee Replacement: A Pilot Randomized Study

Objective

To test the feasibility of a comprehensive behavioral intervention (CBI) program that combines intense exercises with an education program, to be implemented at a later stage (3 months) following total knee replacement (TKR), and to get a first impression of the effects of the CBI as compared to a standard of care exercise (SCE) program on the outcomes of physical function and physical activity.

Methods

A total of 44 subjects participated in a 3‐month program of either CBI or SCE, followed by 3 months of a home exercise program. Outcomes of physical function and physical activity were measured at baseline and at 6‐month followup. Analysis of variance was used to compare statistical differences between groups, whereas responder analyses were used for clinically important differences.

Results

The CBI was found to be safe and well tolerated. As compared to the SCE group, the CBI group had less pain (P = 0.035) and better physical function based on the Short Form 36 health survey (P = 0.017) and the single‐leg stance test (P = 0.037). The other outcome measures did not demonstrate statistically significant differences between the 2 groups. Results from the responder analysis demonstrated that the CBI group had a 36% higher rate of responders in physical function as compared to the SCE group. Also, the CBI group had 23% more responders in the combined domains of physical function and physical activity.

Conclusion

The CBI program is feasible and improves physical function and physical activity in patients several months after TKR. Larger pragmatic randomized trials are needed to confirm the results of this study.

     

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial

ObjectivesThe aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.BackgroundThe TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.MethodsThe authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.ResultsA total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.ConclusionsThe routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).     

Outcome of Direct Oral Anticoagulant Treatment for Acute Lower Limb Deep Venous Thrombosis After Total Knee Arthroplasty Or Total Hip Arthroplasty

Abstract

Objective: The aim of this study was to examine the treatment outcomes of edoxaban and apixaban on deep venous thrombosis (DVT) in Japanese patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA).

Methods: We examined 100 patients receiving edoxaban or apixaban to treat lower limb DVT. The primary efficacy outcome was defined as the disappearance of DVT at three months post-treatment. The primary safety outcome was the change in hemoglobin (Hb) value after two and seven days of treatment compared with baseline, which was the start of treatment with edoxaban or apixaban.

Results: The primary efficacy outcome occurred in 61 of the 70 patients (87.1%) in the edoxaban group and in 28 of the 30 patients (93.3%) in the apixaban group. There was no significant difference between the edoxaban and apixaban groups in the disappearance of DVT at three months (p?=?.497). The change in Hb value from baseline to two days post-treatment was ?0.53?±?0.98 in the edoxaban group and ?0.06?±?0.75 in the apixaban group (p?=?.010). At seven days post-treatment, the changes in Hb were ?0.03?±?1.60 and 0.30?±?0.68 (p?=?.007) in the edoxaban and apixaban groups, respectively.

Conclusion: Edoxaban and apixaban were equivalent in efficacy. However, apixaban was superior to edoxaban in terms of the change in Hb value. In cases of major bleeding, both edoxaban and apixaban need to be used carefully when treating DVT.