IntroductionRecent studies on the use of transforaminal epidural steroid injection (TFESI) to treat lumbar radicular pain have highlighted controversies pertaining to the choice of corticosteroid agent utilized in lumbosacral TFESI, in terms of both safety and efficacy. The primary objective was to characterize the radicular pain response after a first transforaminal injection with dexamethasone. The secondary objective was to document the response of those who failed to respond to a dexamethasone injection when particulate steroid was utilized for a second injection.MethodsIt was a retrospective study of 94 consecutive patients undergoing transforaminal injection for lumbosacral radicular pain. At two-week follow-up, patients rated their pain response on a clinically oriented five-point survey. First injection non-responders were given a second injection with particulate steroid and again completed the survey.ResultsApproximately one-third (N = 31/94) of patients received no meaningful relief from a single injection with dexamethasone. No patients achieved lasting and complete pain relief after a single injection. Of initial non-particulate steroid non-responders, approximately two-thirds (N = 19/28) demonstrated a notable or complete response to a second injection with particulate steroid.ConclusionsWe are now able to better inform patients with regard to their anticipated pain response to an initial dexamethasone injection. Only one-third of patients realized more significant and lasting relief after a single injection. Of those who did not demonstrate a more meaningful response, a second injection with particulate steroid resulted in more pronounced pain relief in two-thirds of patients. Lumbosacral radicular pain is a commonly encountered clinical presentation that can be associated with extreme discomfort, disability, and fear amongst patients. Most commonly, such radicular pain complaints arise from either an acute disc herniation or more chronic degenerative stenosis. Fortunately, the natural history of these cases is often benign and without resultant long-term disability . When moRecent studies on the use of TFESI to treat lumbar radicular pain have highlighted controversies pertaining to the choice of corticosteroid agent utilized in lumbosacral TFESI, in terms of both safety and efficacy. While the overall complication rate is extremely low, case reports of permanent and devastating neurologic injury following lumbosacral TFESI have been reported -10. One Several well-designed studies have now compared the efficacy of TFESI when performed with particulate and non-particulate corticosteroids. While several studies have shown non-inferiority of dexamethasone, one study revealed superior pain relief with the injection of particulate triamcinolone, and another demonstrated a trend toward fewer injections required to achieve similar relief when particulate steroids were injected -19. In lThe purpose of this study was to characterize radicular pain responses to an initial injection with dexamethasone. This information might then better inform clinical expectations for both the interventionalist and the patient, following what can be a long awaited and initial injection procedure. The secondary aim of this study was to characterize the responses of a subset of patients who failed to achieve meaningful pain relief with an initial injection of dexamethasone and then went on to receive a subsequent injection of triamcinolone.MethodsThis retrospective chart review was performed with the approval of the local Institutional Review Board. All injections were performed by one interventional physiatrist in a private physiatric practice in a metropolitan suburb between June 2015 and June 2016. Data was collected retrospectively via electronic medical records. Patients were included in the study if they were over 18 years of age and had a clinical history, physical exam, and imaging studies consistent with prevailing lumbosacral radicular greater than axial pain, as diagnosed by a single fellowship-trained interventional physiatrist with 18 years of clinical experience. The exclusion criteria were: prior injection at the same practice, prior history of lumbar spinal surgery, workers compensation or no fault insurance, and back pain greater than leg pain. Consecutive patients (N = 94) meeting these criteria underwent lumbosacral transforaminal epidural steroid injection with dexamethasone for lumbosacral radicular pain.At a two-week follow-up appointment, patients were asked to rate their pain response on a custom survey. The choices on the survey were: “No improvement at all”, “Improved for a day or two but now no improvement at all”, “There is some but not a marked improvement from the first injection”, “There is a definite and notable improvement after the first injection”, or “I am pain free after the first injection and do not feel that I need another.” To facilitate data analysis, we later assigned a numerical value of 0-4 according to the survey responses Table . PatientAll injections were performed by a single interventional physiatrist according to standard International Spine Intervention Society guidelines . The patData analysisThe primary objective was to determine the percentage of consecutive patients who failed to realize meaningful pain relief after a single injection with the soluble steroid dexamethasone. We analyzed potential differences in therapeutic responses between patients presenting with radicular pain of stenotic vs. discogenic origin. We also examined the effects of multiple demographic factors on potential differences in pain responses after treatment. The secondary objective was to determine the likelihood of a more clinically meaningful response in patients who were treated with a second injection of a particulate steroid after a first injection with dexamethasone failed to provide symptom relief.The frequencies and percentages for each of our clinical and demographic variables were determined. Chi-square and Fisher’s exact testing were utilized in the assessment of categorical variables. The Kruskal-Wallis test was used in the assessment of continuous data. Spearman correlation coefficient was employed to assess the relationship between continuous variables and first injection response.Consecutive patients (N = 94) who had an initial lumbosacral transforaminal epidural steroid injection with dexamethasone for radicular pain were included in this study. Demographic and clinical information for the patients is shown below Table . There wPatients were asked to rate their pain after treatment using a custom survey Table . Of the Among all baseline clinical and demographic data, there was only a significant association between the symptom relief score after the first injection and gender p = 0.04). More females than expected scored “0” on first injection . There was no statistically significant association between symptom relief scores after first injection and age, BMI, diagnosis, smoking status, symptom duration, or diabetes   rated themselves a “0”, three (10.7%) were rated “1”, four (14.3%) were rated “2”, 17 (60.7%) were rated “3”, and two (7.1%) rated themselves a “4” , is also more likely to result in both lasting systemic therapeutic and less desirable adverse responses. We question if this systemic effect of triamcinolone does in fact contribute to the pain response realized by those treated for radicular pain through epidural injections. Following dexamethasone injection, we have also more commonly observed a described level of initial and dramatic relief followed by a return to baseline symptoms two or three days later. A similar dexamethasone injection response was described by 23.4% (n = 22) of patients in the current study. In this study, not a single patient experienced complete pain relief two weeks after their first injection with dexamethasone. Therefore, all patients proceeded to a second steroid injection.Our study found that one-third (33%) of patients did not realize any meaningful pain relief two weeks after a single injection with dexamethasone. This initial lack of a treatment response may be consistent with several well designed studies that revealed a greater number of injections with non-particulates were required to achieve similar degrees of lasting symptom relief than in those treated with particulate steroids . In addiIt is important that this potential lack of a lasting first injection response be faithfully communicated to patients, so that hope is not lost for ultimate therapeutic success following a more complete series of injections. This point, combined with the now available and more robust and well-designed multicenter trials examining the efficacy of dexamethasone injections, might also be highlighted in communications with insurance carriers who might otherwise not allow for second injections.In this study, another third of patients realized “some but not a marked” level of relief two weeks after the first injection. The remaining third of patients described “definite and notable” relief. As a result of these data, at the study site this characterization of initial responses is now used to guide treatment expectations for patients. Patients are advised that they are very unlikely to realize the complete pain relief they desire with a single injection alone. In this study, patients who failed to realize any relief after a first injection of dexamethasone had the opportunity to have a second injection, using a particulate or non-particulate steroid. Within the process of obtaining informed treatment consent, the practice experience, the state of the literature, evolving treatment guidelines, and the incidence and severity of potential complications were described to each patient.Of those patients who chose to receive a second injection of a particulate steroid (triamcinolone), 18% still did not achieve lasting symptom relief at a subsequent two-week follow-up evaluation. The other 82% of patients did achieve lasting pain relief at the two-week visit following a single injection with triamcinolone. Of particular note, 68% realized at least “definite and notable” relief. Seven percent were “pain free” and did not feel additional injection therapy was necessary. No patients who failed to realize lasting benefit from the first injection with dexamethasone chose to proceed with a second injection with the same steroid, so we are unaware of what their response might have been. A choice was given. Patients remained in a good deal of pain, and when offered the educated opportunity, chose to switch steroid. This lack of an ability to compare second injection responses between particulate and non-particulate steroids is a weakness of our study. This second injection response data may be subsequently extracted from previous well-designed studies which completed injection series utilizing dexamethasone alone -19.Multiple prospective outcome studies support the use of dexamethasone for all transforaminal injections -19. The Considering the observations of this paper, clinical experience, the medical literature, and medical legal environment, injection protocols for lumbar radicular pain at the study site practice have evolved. We now use dexamethasone as a first line transforaminal injection approach for all patients with lumbosacral radicular pain. Treatment with dexamethasone without pain relief is not considered a treatment failure until no meaningful response has been realized after two injections with dexamethasone. This assumes the insurance carrier will allow us to proceed without more supportive documentation after an initial injection. Those failed patients after two injections, who wish to continue injection therapy, are offered an interlaminar injection approach with a particulate steroid. Following this paradigm, we have observed several patients who realize a “notable” or “pain free” response after one interlaminar injection. Only in those patients who refuse surgery and whose anatomy or pathology does not allow for an interlaminar injection, a particulate transforaminal injection is offered with informed consent.The science of pain medicine is inexact. We are only just beginning to understand the multifaceted origins of pain and the infinitely varied human responses. The treatment of radicular pain and the spectrum of therapeutic response observed are no exception. Our goal must always remain “to do good, and not to do harm” with the admittedly limited knowledge base we currently possess. The findings of this study will enable us to better educate our patients in terms of their likely response to the first (and often most anticipated) steroid injection to treat radicular pain. Many questions are not addressed by this study. This includes the persistent question of what is the most appropriate and evidence-based next step for those patients with radicular pain who fail to realize any lasting relief after a single injection with dexamethasone.Approximately one-third of patients with lumbosacral radicular pain received no meaningful relief from a first injection of the soluble steroid dexamethasone. Another third of patients realized “some but not a marked” level of relief two weeks after the first injection, while the final third described “definite and notable” relief. No patients in this study were able to achieve complete and lasting pain relief without undergoing a second injection procedure. The likelihood of treatment failure was significantly affected by patient gender, with female patients more likely to report no meaningful pain relief compared to male patients.


Pain assessment is challenging in patients with cognitive impairment that can lead to inappropriate pain management and unfavorable health outcomes. Using a 10% random sample of Medicare home health (HH) patients ≥ 65 years old from the 2017 Outcome and Assessment Information Set (OASIS) national dataset , we tested the relationships of cognitive impairment and constant, severe pain that interfered with daily living activities with acute care utilization . Patients who had constant, severe, interfering pain  were younger, more likely to be female, white, Medicare-Medicaid dually eligible, living alone, and having functional limitations and depressive symptoms, but less likely to have moderate-to-severe cognitive impairment  than others. In multivariable logistic regression models adjusting for the above covariates, when compared with patients with neither cognitive impairment nor severe, constant, interfering pain, those with both conditions were 17% more likely to have hospitalization  and 13% more likely to have an ED admission without hospitalization . This was the first study that examined co-occurring pain and cognitive impairment in HH recipients using national OASIS data. Findings suggest that: 1) older HH patients with moderate-to-severe cognitive impairment have lower rates of reported pain that suggests under-recognition; and 2) having severe, interfering pain among cognitively impaired patients significantly increased their risk of acute care utilization. Therefore, systematic protocols and guidelines should be in place to facilitate pain assessment for improved outcomes among HH patients with cognitive impairment.


This study aims to compare the sleep characteristics  in patients with type-2 diabetes mellitus with and without diabetic neuropathic pain (DNP), and to investigate the relationship of sensory phenotypes, anxiety, and depression with sleep quality in DNP patients. A cross-sectional study was performed in patients with type-2 diabetes mellitus and neuropathy. Patients were classified into two groups—with or without neuropathic pain—according to the “Douleur Neuropathique-4 (DN4)” scale. Sleep characteristics and quality , pain phenotype (Neuropathic Pain Symptom Inventory—NPSI), mood status , pain intensity , and quality of life (SF-12v2) were measured. The sample included 130 patients (65 with DNP). The mean scores in all the dimensions of the MOS-sleep scale were higher (more disturbances) in the DNP patients. Higher scores in anxiety or depression, greater intensity of pain or a higher score in the paroxysmal pain phenotype were associated with lower sleep quality in DNP patients. A shorter duration of the diabetes and lower levels of glycated hemoglobin were also associated with lower sleep quality. The results show the relationship between DNP and sleep quality, and the importance of assessing sensory phenotypes and mental comorbidities in these patients. Taking these factors into consideration, to adopt a multimodal approach is necessary to achieve better clinical results. Sleep is a basic physiological requirement for humans that has been shown to play a part in the correct functioning of memory, emotions, and learning . By the Several studies have shown that between 50–90% of people with chronic pain also suffer from some kind of SD—insomnia being the most common ,6,7—whilIn this vein, several studies have found a relationship between SD and neuropathic pain in patients with DM-2, highlighting the need to include detailed assessments of pain when exploring the SD of these patients . The anaFinally, it is worth highlighting that negative mood and anxiety are frequently observed processes in diabetic patients  and patiDue to the potential relevance of SD in patients with DM-2, this study aims to compare the sleep characteristics  in all their dimensions in patients with DM-2 with and without diabetic neuropathic pain (DNP), and as a second objective, to investigate the relationship of anxiety, depression, and the sensory phenotypes of pain with sleep quality in DNP patients.A cross-sectional study was carried out between June 2017 and July 2018 in 4 primary health care centers in Cádiz (Spain). The patients participating were adults diagnosed with DM-2, based on the criteria of the American Diabetes Association (ADA), and others with diabetic neuropathy, based on a clinical examination and the monofilament test .All the participants had to be mentally and physically able to answer the questionnaire and to provide their written informed consent in advance. The study was approved by the Clinical Research Ethics Committee of the University Hospital “Puerta del Mar”  (Reference Number of the study: 36/17), ensuring compliance with the standards of good clinical practice, and it was performed in accordance with the Helsinki Declaration.Patients were selected from the “Diabetes Mellitus Integrated Care Process”, registered in an electronic unique health record system for primary care management . Approximately 2000 DM-2 patients were initially identified from this system. Then, the selection of the individuals with diabetic neuropathy was based on searching for patients at risk who presented at least one of three indicators of poor control of the diabetes mellitus: a glycated hemoglobin (HbA1c) level over 8%; a diagnosis of diabetic retinopathy or foot ulcers; and having been first diagnosed with the illness more than 10 years earlier. The patients selected were contacted, had the objectives and characteristics of the study explained to them, and were invited to participate. The patients who agreed to participate attended a meeting at the primary care center, where they were informed about the right to withdraw from the interview at any time and the need for their informed consent.A well-trained member of the research group conducted the clinical interview and performed the foot examination with the monofilament test according to the standard procedure. Patients with a negative examination, presenting mental impairment, or who were unable to complete the questionnaire were excluded from the study. Finally, a sample of 130 patients with DM-2 and neuropathy was obtained.These patients were classified into two groups, with or without neuropathic pain (case and controls respectively) depending on the results in the “Douleur Neuropathique 4 questions (DN4)” scale . This inThe sociodemographic, clinical, and sleep characteristics  of both groups were described. Furthermore, the factors related to sleep quality were analyzed in the patients with neuropathic pain (DNP).Information was collected from each patient’s medical records and from a structured questionnaire.The Medical Outcomes Study (MOS) Sleep Scale was used to assess sleep characteristics . This is a validated scale in Spanish with appropriate psychometric properties to assess the sleep characteristics of patients with chronic pain (including neuropathic pain) with good reliability, validity, and sensitivity to change ,22. ThisFurthermore, data were gathered on sociodemographic variables , and on clinical variables such as time since diagnosis of DM-2, duration of DNP, treatment with insulin, presence of cardiovascular risk factors , last level of glycated hemoglobin (HbA1c) recorded, pharmacological treatment for sleep or for pain relief, and presence of DM-2 complications . Data on physical comorbidities were also collected. A patient was considered to have physical comorbidities if they had any other pathology in their medical record other than the diabetes complications, cardiovascular risk factors, mood disorders, or sleep problems previously considered.The neuropathic pain phenotype was identified using the Neuropathic Pain Symptom Inventory (NPSI). This scale, which is also adapted and validated in Spanish, presents different values of sensitivity and specificity depending on the criterion used. First, the authors propose a clinical criterion: a reduction of at least 30% of the NPS total score from the first to the second assessment and/or an absolute two-point reduction in the first item. With this criterion, a sensitivity of 68.0% and a specificity of 87.2% were observed. A second criterion (discriminant criterion) is based on the score of the discriminant function of the Neuropathic Pain Questionnaire-Short Form (NPQ-SF). This score is used to classify patients with and without a relevant neuropathic component at the second assessment. With this criterion, a sensitivity of 85.0% and a specificity of 75.2% were found. This scale includes 12 items: 10 descriptors allow us to quantify the five most relevant clinical dimensions of the neuropathic pain syndrome scored with a range of 0–10 . The dimPain intensity was measured using a visual analogue scale (VAS) with a range of 0–10, with 0 corresponding to no pain and 10 to the worst pain possible.The Hospital Anxiety and Depression scale (HAD)  was usedQuality of life (QoL) was measured using the SF-12 v2 Health Survey . This int-tests, ANOVA, Mann–Whitney U, Kruskal Wallis, and correlation coefficients (Pearson or Spearman) were performed, depending on the type and on the distribution of the variables, assessed by the Kolgomorov–Smirnov test. Furthermore, Pearson or Spearman coefficients were calculated to analyze the correlations between each dimension of the MOS-Sleep Scale and each dimension of the NPSI, in the diabetic patients with neuropathic pain.A descriptive analysis was performed in both groups of patients (with and without neuropathic pain) using measures of frequency, central tendency, and dispersion. In addition, to analyze the associations between the variables studied  and the two groups of patients (with and without neuropathic pain), and to compare the structure and quality of sleep in both groups and the associations of the Sleep Problem Index (I-9) of the MOS sleep scale with the variables studied, chi-squared tests, p < 0.05) identified in the bivariate analysis and those considered relevant according to the scientific literature. Tolerance and the variance inflation factor (VIF) were also computed. We assumed that collinearity was not present when the VIF value was below 5 and the tolerance score over 0.2 [Finally, in the patients with DNP, a multivariate linear regression model was performed to analyze the variables related to sleep quality (measured with the I-9), where the dependent variable was the Sleep Problem Index (I-9) of the MOS sleep scale. Included in the models were the significant variables .These analyses were all carried out with the IBM SPSS Statistics 24Of the 130 individuals included in this study, 65 had DNP. As observed in The patients with DNP took sleep medication with greater frequency (55.4% vs. 30.8%) for pain relief (76.9% vs. 52.3%) and were under treatment with insulin (69.2% vs. 50.8%) . LikewisIn the DNP patients, the pain duration was 4.8 years (SD = 3.4) on average and the pain intensity was 7.48 (SD = 2.2). In the NPSI dimensions the highest scores were paresthesia/dysesthesia (5.43 SD = 2.75), followed by paroxysmal pain (4.85 SD = 2.95) and superficial spontaneous pain (4.26 SD = 3.95). The score in evoked pain (3.23 SD = 2.58) and deep spontaneous pain (3.23 SD = 2.58) were lower.As shown in r = 0.305) and the Sleep Problem Index (I-9) (r = 0.277), while deep spontaneous pain and paresthesia/dysesthesia were significantly related with the short of breath or headache dimensions . In all cases, a higher score in the dimension of sensory phenotype was associated with greater sleep problems  .Worse sleep quality was observed in the patients with a higher score on the HADS-D and HADS-A scale (depression and anxiety), as well as among those taking medication for sleep . With reThe variables indicating that patients were taking medication for sleep and for pain relief were initially included in the models as they were possible confounding variables. However, they were found not to be significant and did not alter the coefficients of the remaining variables in the models so they were removed from the final models.This study analyzes the differences in the characteristics  of sleep in patients with type-2 diabetes with and without neuropathic pain, in addition to the factors associated with sleep quality in DNP patients, including sensory phenotypes.Of note among the results obtained, the score in the MOS-sleep scale was higher (more sleep disorders) among the patients with DNP than among those not presenting neuropathic pain, and the differences between these groups were observed in all the dimensions of the MOS sleep scale. These results are in agreement with those reported by other authors, such as Zhu B et al. (2018) and Tanik N et al. (2016), who show a relationship between DNP and the presence of sleep disorders in DM-2 patients ,32, and Sleep problems have been shown to be an emerging factor associated with a greater risk of diabetes. Systematic reviews and meta-analyses have demonstrated that a low quantity and quality of sleep increases the risk of developing DM-2 , and thaWhat is particularly significant in the study is that in the DNP patients, the pain intensity and the evoked pain and paroxysmal pain phenotypes presented positive correlations with different dimensions of the MOS sleep scale , while evoked pain correlated negatively with the quantity of sleep.These results support the hypothesis that the expression of pain in DNP patients will affect sleep quality in different ways, and are in agreement with those obtained by other authors, who highlight the importance of analyzing sensory phenotypes and their potential therapeutic implications ,36,37. CIn a review of the mechanisms that may explain the presence of neuropathic pain in diabetic patients, Rosenberger et al. (2020) indicate that lesions or diseases affecting the somatosensory nervous system not only lead to a loss of function, but also to overexcitability and increased sensitivity to painful stimuli , pain sensations to normally non-painful stimuli  and spontaneous pain . AlthougAnother result of the study is that higher scores on the HADS anxiety and depression scales were associated with higher scores in the Sleep Problem Index (I-9) of the MOS-sleep scale . Earlier studies have shown a relationship between chronic pain, depression, and SD, suggesting the existence of neurobiological correlations between these processes . Ojeda eA shorter time evolution of DM-2 was another variable associated with higher scores in the Sleep Problem Index (I-9) of the MOS-sleep scale among the patients in the study. These results could be explained by the fact that sleep quality can be affected by factors related to adaption to diabetes, recently-diagnosed patients being less adapted. This result could also be explained by the presence of other common comorbidities in these patients . HoweverThe patients with better levels of HbA1c also presented higher scores in the Sleep Problem Index (I-9). Although these results may appear to contradict those reported by other authors, they are in agreement with those presented by Zhu et al. (2017) in a review of the relationship between sleep disturbance and glycemic control in adults with DM-2 . They foFinally, it is worth mentioning that the DNP patients were taking more medication for sleep and pain control than those not suffering from pain. However, when these variables were introduced into the models, the coefficients of the other variables remained unchanged, which is why they were excluded.Among the limitations of the study, it is important to highlight that the sample was obtained using a consecutive non-random sampling technique based on the selection of high-risk type-2 diabetic patients due to the lack of a record of patients with diabetic neuropathy and DNP. This procedure could justify the small differences observed between the groups.An additional limitation was that detailed information about the subjects’ treatment was not collected. Furthermore, the cross-sectional design of the study is a limitation in itself, as it does not allow for the analysis of causal relationships between the variables analyzed.As a strength, we would highlight the inclusion of the NPSI, with proven validity and a high correlation with other measures of patient sensitivity such as QST , which hThe results obtained show the relationship between DNP patients and the quality of their sleep, and the importance of assessing sensory phenotypes and mental comorbidities in these patients. Taking these factors into consideration supports the belief that it is necessary to adopt a multimodal approach to achieve better clinical results for these patients.


Osteoporotic fractures are common among older people, and hip fractures (HF) can be devastating. Surgery is indicated for most cases of HF, and chronic persistent postoperative pain is likely to occur. This study investigated the multifaceted factors related to persistent pain occurring during the acute phase and subacute phase of recovery after HF surgery. We conducted a prospective 8-week study of older HF patients after surgery. We evaluated pain intensity, depression symptoms, the fear of falling, pain catastrophizing, cognition and attention, the ability to perform activities of daily living, and the physical performance at 2 weeks (acute phase) and at 4 weeks (subacute phase) after surgery. Patients were divided into the light group  score ≤1) and severe group (VRS score ≥2) according to pain intensity at 8 weeks (recovery phase) after surgery. Factors affecting persistent postoperative pain during recovery were examined using logistic regression analysis. Seventy-two patients were analyzed: 50 in the light group and 22 in the severe group. In the severe group, pain with movement and Pain Catastrophizing Scale scores were higher than those of the light group at 2 weeks and at 4 weeks after surgery. The regression analysis showed that pain with movement at 2 weeks and at 4 weeks after surgery and pain catastrophizing at 4 weeks after surgery were related to persistent postoperative pain. HF patients may have persistent pain if they continue to experience pain and catastrophize their pain during the acute phase and subacute phase after surgery. Osteoporotic hip fractures (HF) are an unfortunate but common source of morbidity and mortality in elderly individuals. HF often occurs due to trauma caused by falling . In 1999Cross-sectional research has shown that factors related to chronic persistent postoperative pain include severe pain, cognitive impairment, and psycho-emotional problems such as depression and catastrophizing , 8. AddiThe reasons underlying failure to recover from acute and subacute episodes of chronic persistent pain after HF surgery are not yet understood. Furthermore, a consensus has not been achieved regarding which factors are most highly associated with poor outcomes and persistent postoperative pain for HF patients. We investigated the multifaceted factors occurring in the acute phase and subacute phase after surgery that were related to persistent postoperative pain during recovery.This study was conducted from April 2014 to October 2018. Patients older than 65 years who were admitted to the emergency unit at Nagasaki Memorial Hospital in Nagasaki, Japan, with a femoral neck fracture or femoral trochanteric fracture after a fall diagnosed by radiography were included. Exclusion criteria for this study comprised the transfer from another hospital, acute exacerbation, repeat fracture, discharge within 4 weeks after surgery, inability to walk within 4 weeks after surgery, and decline in cognitive function causing an inability to understand the questionnaire. The study protocol was approved by the Research Ethical Committee at the Graduate School of Biomedical Sciences at Nagasaki University . All patients provided signed consent.Data were collected prospectively. Cognition and attention, depression symptoms, the fear of falling, pain catastrophizing, pain intensity, the ability to perform ADL, and the physical performance at 2 weeks and at 4 weeks after surgery  were measured by a physical therapist. To determine the physical performance, handgrip strength was measured at 2 weeks and at 4 weeks after surgery; other standing and gait assessments were measured only at 4 weeks after surgery. Radiological measurements were performed by a physical therapist who received specialized training from an orthopedist.During the preoperative phase, therapists instructed their patients on strengthening and range-of-motion exercises (upper extremities and lower extremities without fracture). On the day of surgery, no rehabilitative procedures were performed.T-cane or independent gait as tolerated and strength and balance training were started. The physical therapist dedicated more than 60 minutes daily to each patient.After surgery, patients were mobilized out of bed and stand-up or ambulation training was initiated, depending on the surgical treatment . First, with the therapist providing instructions, the patient received assistance getting out of bed and into a chair. Then, weight-bearing (as tolerated) training and stand-up or ambulation training with moderate assistance were started. Next, patients were trained to perform ambulation with a walker. Finally, progressive ambulation with a γ nail or pinning) of each patient. Additionally, we investigated the ability of each patient to perform basic ADL and instrumental ADL (IADL) before admission. The performance of basic ADL was determined using the Barthel index (BI) [We measured each patient's height and weight to calculate the body mass index. We also recorded the age, sex, length of hospital stay, fracture type , and type of surgery (bipolar hip arthroplasty (BHA) or compression hip screw (CHS) or dex (BI) . The BI dex (BI) , 14. IADdex (BI) .Pain intensity, which was defined as the strongest pain level of the day, was measured using a 5-point Verbal Rating Scale (VRS) . Pain at rest and pain during standing and walking were measured .The Pain Catastrophizing Scale (PCS) reported by Sullivan et al. includes 13 items and comprises three categories: rumination (five items), helplessness (five items), and magnification (three items). Each item is assessed using a 5-point scale ranging from 0 points  to 4 points , with a total score ranging from 0 to 52 points; higher scores indicated greater catastrophizing . To asseGeneral cognitive function was measured using the Japanese version of the Mini-Mental State Examination (MMSE) , 22. TheWe used the functional independence measure (FIM) to determine the generic ability to perform ADL. This performance-based disability tool assesses the level of disability when performing basic ADL –28.Handgrip strength (kg) was measured using a digital hand dynamometer  in the standing position; a maximum of two measurements of the dominant hand was recorded .During the sit-to-stand (5STS) test, patients were asked to stand up and sit down as quickly as possible five times with their arms crossed in front of their chest. The floor-to-seat height was 45 cm . The timThe six-minute walking test (6-MWT) was used to assess if the functional exercise capacity correlated with physical fitness. This test measures the distance (in meters) that a patient can quickly walk on a flat, hard surface during a period of 6 minutes .During this study, persistent postoperative pain was defined as pain that persisted for 2 months (8 weeks) after surgery (the recovery phase). Pain with movement scores at 8 weeks after surgery were analyzed as no pain or light pain  or moderate to severe pain ; and no patients reported intolerable pain (VRS score = 4). Based on previous research , all datt-test, Mann–Whitney U test, and chi-square test were used to compare the basic survey items of the light group and severe group at each evaluation time point. After comparisons were performed, a logistic regression analysis was performed to examine factors affecting persistent postoperative pain associated with HF. All significance levels were set less than 5%.An unpaired From January 2014 to October 2018, 266 patients were admitted to our hospital with a fracture of the proximal femur and 242 patients underwent open osteosynthesis and BHA. The following were excluded: patients transferred from other hospitals, patients with acute exacerbation, patients with repeat fracture, patients discharged within 4 weeks after surgery, patients unable to walk before injury, patients who could not comprehend questions due to cognitive impairment, patients unable to walk 4 weeks after surgery, patients younger than 65 years, and patients without sufficient data. As a result, 72 patients were analyzed .Regarding pain with movement at 8 weeks after surgery, of the 72 total patients, 30 (41.7%) had a VRS score of 0, 20 (27.8%) had a VRS score of 1, 15 (20.8%) had a VRS score of 2, and 7 (9.7%) had a VRS score of 3. Therefore, 50 (69.4%) patients were in the light group and 22 (30.6%) were in the severe group.There were no significant differences between the light group and severe group regarding age, sex, body mass index, length of hospital stay, fracture type, the prehospital ability to perform ADL, and the prehospital ability to perform IADL .At 2 weeks after surgery, the mean VRS scores for pain at rest were 0.29 ± 0.5 in the light group and 0.72 ± 1.2 in the severe group; the severe group had significantly higher values than the light group. Additionally, the mean VRS scores for pain with movement were 1.25 ± 1.1 in the light group and 2.14 ± 1.0 in the severe group; the severe group had significantly higher values than the light group. The GDS and FES scores were not significantly different between the light group and severe group. The mean total PCS scores were 20.5 ± 11.5 points in the light group 2 weeks after surgery and 26.4 ± 11.0 points in the severe group. The severe group had significantly higher scores than the light group.The MMSE and TMT-A scores were not significantly different between the light group and severe group. The mean FIM score was not significantly different between the light group and severe group. There was no significant difference in grip strength between the light group and severe group .At 4 weeks after surgery, there was no significant difference in pain with movement in the light group and severe group. However, the mean VRS scores for pain with movement were 0.94 ± 1.94 in the light group and 2.13 ± 0.8 in the severe group. The severe group had significantly higher scores than the light group. The GDS and FES scores were not significantly different between the light group and severe group. The mean total PCS scores were 14.9 ± 10.3 points in the light group and 27.3 ± 10.1 points in the severe group. The severe group had significantly higher scores than the light group. The MMSE and TMT-A results were not significantly different between the light group and severe group. The mean FIM score was not significantly different between the light group and severe group. There was no significant difference in the results of grip strength, 5TST, TUG, and 6-MWT between the light group and severe group .To investigate the factors related to persistent pain at 8 weeks after surgery, a logistic regression analysis was performed using pain with movement at 8 weeks after surgery as a dependent variable. Factors that showed significant differences between the two groups  were used as independent variables. The factor affecting pain persistence at 8 weeks after surgery and at 2 weeks after surgery was pain with movement (odds ratio (OR), 1.91; 95% confidence interval (CI) 1.06-3.47). However, factors affecting pain persistence at 8 weeks after surgery and at 4 weeks after surgery were pain with movement  and total PCS score  .We examined the multifaceted characteristics and pain-related factors in HF patients during the acute and subacute phases  after surgery and determined the factors related to persistent postoperative pain during the recovery phase (8 weeks after surgery). A comparison of the light group and severe group suggested that severe pain and catastrophizing at 4 weeks after surgery were characteristics of patients with persistent postoperative pain. The regression analysis indicated that factors related to persistent postoperative pain were pain with movement at 2 weeks after surgery and pain with movement and PCS score at 4 weeks after surgery.In this study, 22 of the 72 patients (30.6%) had severe pain at 8 weeks after surgery. In a previous study, 49% of the patients had persistent pain at 3 months after total knee arthroplasty . FurtherPain with movement at 2 weeks (acute phase) and at 4 weeks (subacute phase) after HF surgery was related to persistent postoperative pain at 8 weeks. It has been reported that severe pain persisting 3 months after total knee arthroplasty cannot be controlled . AdditioThe PCS score and pain with movement at 4 weeks after surgery were factors related to pain at 8 weeks after surgery. Patients who underwent total knee arthroplasty  and loweOne of the limitations of this study was that the grouping based on the VRS score was not exact. We investigated factors affecting pain only during the acute and subacute phases; therefore, factors affecting pain during the chronic phase (3 to 6 months postoperatively) must be investigated. The types of surgical procedures performed for HF vary and are not uniform. Finally, the sample size was small and power analysis was not performed; therefore, the analysis was not sufficient.For HF patients, pain with movement at 2 weeks and at 4 weeks after surgery and the PCS score at 4 weeks after surgery were related to persistent postoperative pain at 8 weeks after surgery (recovery phase). Therefore, if patients experience severe pain during the acute phase after HF surgery, and if severe pain and catastrophizing occur during the subacute phase, then persistent postoperative pain is likely to occur during the recovery phase. Interventions including psychological support are necessary during the acute phase to prevent persistent postoperative pain.


The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty.This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction.This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome.This study protocol was registered in Research Registry (researchregistry5524). To help control pain, patients can receive a multimodal drug regimen, ice, and physical therapy.Total hip arthroplasty (THA) has been one of the most successful medical procedures from the start, alleviating pain and restoring function in patients suffering from the consequences of a spectrum of hip pathologies. Pharmacodynamic and pharmacokinetic properties of buprenorphine have recently been thoroughly updated and documented in a review by Kress. The longer half-life of buprenorphine and its high affinity to the μ-receptor, make it longer lasting and 25 to 100 times more efficacious (per mg) as an analgesic than morphine.Buprenorphine is a semi-synthetic opioid, a derivative of the opium alkaloid thebaine. Buprenorphine has been in regular clinical use for 3 decades, administered as sublingual tablets or as injections for acute or chronic pain. Following removal of the patch, concentrations decrease to about one-half in 12 hours, and then decline more gradually with an apparent half-life of about 26 hours. These pharmacokinetics should minimize some of the adverse effects typical of fast onset, fast offset delivery of potent opioids. It allows a practical means of administering the drug to patients who may be unable to take medication orally and to elderly patients with cognitive dysfunction or impaired memory.The molecular structure of buprenorphine confers suitability for use in a variety of preparations, including the transdermal route. Transdermal drug delivery systems are non-invasive, simple, compliant, and sustained methods of delivery. Buprenorphine is highly lipophilic and therefore suitable for transdermal administration. For usage as transdermal patch, buprenorphine is incorporated into an adhesive polymer matrix (acrylate vinyl acetate), from which it is continuously released into the systemic circulation over a period of 7 days. Buprenorphine transdermal patch (BTP) is available in 3 strengths 5, 10, and 20 mg with rate of drug release of 5, 10, and 20 μg/h, respectively. Therefore, we design a randomized controlled trial (RCT) to evaluate the effectiveness and safety of the BTP for postoperative analgesia in THA.As far as we know, the efficacy and safety of BTP has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. In addition, few studies have been performed on the use of the BTP for THA surgery.22.1This study is designed as a single-center, prospective, double-blind RCT. The participants will be randomly assigned to either the BTP group or the control group.2.2This study was approved by the institutional review board in our hospital (B200410023) and was registered in Research Registry (researchregistry5524). This trial will be performed in accordance with the principles of the Declaration of Helsinki (Edinburgh 2000 version). Written informed consent will be obtained from each participant before enrollment.2.3http://www.randomization.com). None of the investigators, except for the pharmacists, will be aware of the block size. The random allocation sequence will be available to pharmacists only and thus it will be concealed from the other research team members. The included participants will be randomly assigned to either the BTP group or the control group in a ratio of 1:1. The pharmacist who administers the drugs has no further role in the study; the surgeons, anesthesiologists, and nurses providing intra- and postoperative care, as well as the research coordinator assessing outcomes, are all kept blinded to allocation results.A pharmacist will provide a set of 160 random numbers for the allocation sequence using a website , a history of intravenous drug abuse and alcohol abuse are also excluded from the study. Participants are informed that the study is evaluating the efficacy and safety of BTP for pain control following primary THA and that they are randomly assigned to either the BTP and control group.2.5Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. No other opioid medications, non-steroidal anti-inflammatory drugs , or antidepressants are used.2.6All patients are managed with general anesthesia without regional block or epidural anesthesia. No periarticular injection of local anesthetic is used in any of the study patients. All surgeries are performed by 1 of the 2 surgeons. In all cases, a minimally invasive anterolateral approach is used with the patients placed in a lateral decubitus position. We use a cementless cup in all cases for the acetabular component. All patients begin gait exercise and range of motion training without any precautions on the day after surgery.2.72.7.1The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. Subjects receive standardized postoperative multimodal analgesics. Supplemental oxycodone 5 to 15 mg every 3 hours for pain is available to each subject. Nurses administer a 5 mg oxycodone tablet for numerical rating scale (NRS) scores of 1 to 3, 10 mg for NRS scores of 4 to 6, and 15 mg for NRS scores of 7 to 10. Oral hydromorphone is substituted for oxycodone in the instances of patient allergy or intolerance. Rescue analgesia is available with IV hydromorphone 0.5 mg every 1 hour as needed for pain of greater than NRS of 7 when refractory to oral opioids. Opioid consumption during the first 48 hours postoperatively is retrieved from the electronic medical record and convert to IV morphine equivalents for analysis. The average and worst NRS pain scores at rest and with activity are determined by blinded investigators at 24 and 48 hours postoperatively.2.7.2The secondary outcomes included NRS scores at rest, postoperative complications, length of hospital stay, and patient satisfaction. The NRS scores at rest are measured at 12, 24, 48, and 72 hours postoperatively. Any postoperative complications occurring during the course of the trial are recorded. Length of hospital stay is calculated by measuring the time from the completion of surgery through discharge for each patient. Subjects are asked to give a verbal assessment representative of the quality of analgesia at 24 and 48 hours postoperatively. Response to this assessment is recorded as “satisfied”’ or “unsatisfied.”2.8We estimate that with 64 participants in each group, the study will have more than 80% power to detect a clinically important difference between the groups in regard to the change in the pain score evaluated with the NRS. This is assuming a mean intergroup difference in score of 20 mm based on previous literature and a pooled standard deviation of 35 mm on the basis of preliminary data at an alpha level of 5%. Based on this estimation, a total of 160 patients are needed with an allowance for 10% drop-out.2.9t test is used to compare the primary outcome between groups in this study. For missing primary outcome data, NRS scores are replaced with the median scores for other patients of the same treatment group at the same period. Comparisons between the study groups are performed using Chi-squared test and Student t test for categorical and continuous variables, respectively. All tests are 2 sided, and P < .05 is considered statistically significant.All statistics are performed using STATA software (StataCorp). Student 3Figure 4 The BTP offers many advantages over the typical full μ-opioid receptor agonists for treating chronic pain, and its partial agonist activity induces a ceiling effect for respiratory depression but not for analgesia, thereby resulting in a reduced risk for this potentially fatal adverse event compared with that of other full opioid agonists.The BTP is a type of synthetic opioid analgesic, and it was licensed for the treatment of moderate-to-severe chronic pain that does not respond to nonopioid analgesics. The active ingredient of the BTP is buprenorphine, which is a potent opioid analgesic that acts primarily as a partial agonist at the μ-opioid receptor.–12 and only 1 in THA. In THA surgery, inadequate postoperative pain control may cause delay in recovery, prolonged hospital stay, delay in start of physiotherapy, and may even adversely affect the outcome of surgery. Thus, the present randomized, double-blind, controlled study is undertaken to evaluate the safety and efficacy of BTP after THA.The role of BTP in chronic malignant and non-malignant conditions is well proven. However, there are only few studies with BTP for postoperative analgesiaThere are several limitations of this randomized trial. First, this study does not measure levels of depression or other conditions which have been shown to influence the perception of pain. However, randomizing patients to each group decreases the likelihood of this having a significant impact on the results. Secondly, owing to the small sample size, this study is also not powered to detect a difference in length of stay or other secondary outcomes. Despite these limitations, this trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary THA and powered to detect a potential difference in the primary outcome.Conceptualization: Li-Chen Sun.Data curation: Wen-Min Li, Hua Xu.Formal analysis: Wen-Min Li, Feng-Dao Li, Hua Xu.Funding acquisition: Li-Chen Sun.Investigation: Wen-Min Li, Feng-Dao Li, Hua Xu.Methodology: Li-Chen Sun.Resources: Li-Chen Sun.Software: Feng-Dao Li.Supervision: Li-Chen Sun.Validation: Li-Chen Sun.Visualization: Li-Chen Sun.Writing – original draft: Wen-Min Li.Writing – review & editing: Feng-Dao Li, Hua Xu.


This study evaluated the prevalence of radiographic abnormalities potentially indicative of femoroacetabular impingement on AP pelvic radiographs in asymptomatic adolescents and young adults and aimed to determine whether the abnormalities were predictive of future hip pain.AP pelvis images from scoliosis radiographs were obtained from patients 12 to 25 years of age free of any clinical hip/lower extremity symptoms between January 2006 and September 2009. The following radiographic abnormalities were collected: lateral center-edge angle of Wiberg >40° or <25°, Tönnis angle <0° or >10°, acetabular retroversion , acetabular overcoverage , and anterior offset alpha angle, calculated using alpha angle of Nötzli >50°. Patients were retrospectively followed (average 3.11 years) to identify those who subsequently developed hip pain.P = 0.0006) and the presence of acetabular retroversion  were predictive of the development of future hip pain.Of the 233 patients (466 hips) who were asymptomatic at the time of radiographic evaluation, at least one radiographic abnormality was present in 60% (281/466) of the hips. Within that group of hips (n = 281), 69% (195/281) of hips demonstrated a single abnormality, whereas 31% (86/281) of hips were associated with multiple abnormalities. Among all hips (n = 466), a lateral center-edge angle <25° or >40° was the most common radiographic abnormality, present in 27% (127/466) of hips. Anterior offset alpha angle and acetabular overcoverage were the most common abnormalities to present together, found in 5% (25/466) of hips. In the multivariable model, a decreasing Tönnis angle (hazard ratio per 1-degree decrease: 1.25, 95% confidence interval, 1.10–1.42, Our study demonstrates a high prevalence of radiographic abnormalities indicative of femoroacetabular impingement in asymptomatic adolescents and young adults. A decrease in Tönnis angle and the presence of acetabular retroversion were predictive of future hip pain. It is a common source of hip pain in young and active patients, with a prevalence between 10% and 15%.8 A systematic review evaluating 2,114 asymptomatic hips found that 67% had radiographic evidence of a pincer deformity, and 37% had evidence of a cam deformity.9 This review by Frank et al, along with other reviews, mainly focused on adult populations.1 Only a handful of reports have evaluated radiographic evidence of FAI in asymptomatic adolescent populations.10-12 More importantly, it is assumed that the radiographic abnormalities precede the onset of hip pain. The clinical dilemma is the determination of those specific individuals whose radiographs have parameters indicating FAI and will develop early onset degeneration. No previous study has followed asymptomatic adolescent patients to determine whether the radiographic abnormalities, present at the baseline asymptomatic visit, increase the risk of future hip pain with subsequent cartilage degeneration.Radiographic evidence of FAI can assist in clinical decision-making, but multiple reports have highlighted asymptomatic populations with radiographic evidence of FAI.The aim of this cross-sectional study was to establish the prevalence of radiographic abnormalities indicative of FAI among asymptomatic adolescents and young adults. Using a cohort study design, we also aimed to determine whether the radiographic abnormalities obtained from the cross-sectional portion of the study predicted the development of future hip pain.After institutional review board approval, we retrospectively reviewed the pelvic portion of standing spinal radiographs obtained from individuals referred for potential idiopathic scoliosis (IS) at a single quaternary-referral children's hospital from January 2006 through September 2009. We included all radiographs obtained from patients 12 to 25 years of age with no previous hip complaints, no known hip deformity, or diagnosis of a neuromuscular disorder. Patients with pelvic radiographs with open triradiate physes were excluded.2Radiographs were independently reviewed by a fellowship-trained pediatric orthopaedic surgeon with experience in hip preservation. The AP pelvis portions of the images were analyzed to confirm that the pelvis was centered and lacked any significant rotation in all planes (including flexion/extension). Lack of rotation was confirmed through correct alignment of the sacrum with the pubic symphysis in the coronal plane and a distance of 1 to 4.5 cm measured between the sacrococcygeal joint to the superior border of the pubic symphysis.13Images were reviewed using (PACSWEB) the digital measurement software tools to evaluate the following five radiographic abnormalities described as potential indicators of FAI: lateral center-edge (LCE) angle of Wiberg >40° or <25°, Tönnis angle < 0° or >10°, acetabular retroversion , acetabular overcoverage , and anterior offset alpha angle (AOAA) .A cohort study design was used to determine whether patients in the cross-sectional analysis developed hip pain after the baseline radiographic evaluation. Only patients with one or more clinical follow-up visits were included in the cohort analysis. Patient charts were retrospectively reviewed to identify the incidence of hip pain, defined as a report of pain in the groin during routine daily activity that may or may not increase with higher-intensity activities such as sports. Patients were followed for an average of 3.1 years  after their baseline radiograph.Descriptive statistics were used to estimate the prevalence of the five hip radiographic abnormalities according to the number of hips included in the data set  and the number of patients included in the data set . In the cohort analysis, Cox-proportional hazard models were used to test the association between radiographic abnormalities at baseline and the incidence of hip pain. Correlation because of the inclusion of multiple hips per patient was accounted for in the statistical models. All radiographic abnormalities were tested in separate models. Radiographic variables significantly associated with onset of hip pain were tested together in the final, multivariable model. Age and sex were included as covariates in all statistical models.A total of 233 patients (466 hips) met the inclusion criteria. Consistent with the demographics among patients referred for treatment of adolescent IS at our institution, 78% were women (181/233) and 22% were men (52/233). The mean age at the baseline radiograph was 14.7 years . The average LCE angle was 31.9° , and the average Tönnis angle was 4.8°  among all hips.Most hips included in the final analysis, 60% 281/466), presented with at least one and as many as four radiographic abnormalities  of the hips ; acetabular retroversion was most likely to present with AOAA , and a Tönnis angle <0° or >10° was most likely to present with an LCE angle <25° or >40° .At the patient level, one or more radiographic abnormalities were present in at least one hip in 72% of the patients Table . The abnP = 0.006) and presence of acetabular retroversion  were the only radiographic abnormalities significantly associated with the incidence of hip pain.The hips were followed for an average of 3.1 years after the initial baseline, radiograph. Among these hips, 13 (3%) developed hip pain. The median time to onset of hip pain was 3.3 years . We tested the association between radiographic abnormalities at baseline and the hazard of hip pain  in 90 asymptomatic patients (180 hips) using an EOS Imaging technique.11 Coxa profunda was present in 81.7% of the hips. Nepple et al14 have discouraged the use of coxa profunda to diagnose pincer impingement because of its high prevalence in asymptomatic hips. Based on these factors, we did not include coxa profunda in the current study. Schmitz et al11 also observed that acetabular overcoverage  was present in 15% of asymptomatic hips. Acetabular overcoverage, defined in our study as the presence of the crossover sign without a posterior wall sign, was present in 13% of the hips in our study. Acetabular over or under coverage, LCE <25° or >40°, was present in 27% of the hips in our study. The current study corroborates the high prevalence of radiographic FAI abnormalities among asymptomatic individuals.Our study represents a large cohort of initially asymptomatic adolescent and young adult individuals with standard pelvis radiographs (466 hips). Schmitz et al14 Specific radiographic abnormalities also tended to be correlated. Acetabular overcoverage and an AOAA were the most prevalent combination of abnormalities, present in 5% of hips.Our results also demonstrate a high level of within patient correlation, as indicated by the high prevalence of radiographic abnormalities present bilaterally Table . CorrelaA major limitation of the previous cross-sectional designs used to estimate the prevalence of FAI abnormalities in asymptomatic hips has been the lack of follow-up data to determine whether abnormalities are predictive of future hip pain. Assuming that anatomic variants contribute to future hip pain, the anatomic abnormalities must precede the onset of hip pain. FAI abnormalities could represent latent hip pain. Therefore, we followed patients to determine whether patients sought care for hip pain after the baseline radiograph. In the final multivariable analysis, after adjusting for age and sex, a decreasing Tönnis angle and the presence of acetabular retroversion were significantly associated with the onset of hip pain. Although not significant, hips that developed pain were associated with a higher number of FAI abnormalities, 1.2, compared with hips that did not develop pain, 0.8. These findings suggest that FAI radiographic abnormalities may have utility in the overall clinical and radiographic assessment and prediction of future hip pain.15 We may be underreporting the prevalence of AOAA in this study cohort using only the AP pelvic images; however, it should be noted that our prevalence of AOAA is similar to other studies that used advanced imaging such as MRI and EOS.11 Finally, it should be noted that coexisting hip and spine pathologies have been reported in the literature, suggesting that patients with IS may have a predisposition to the development of hip issues.17This study includes several limitations. The cross-sectional analysis was based on AP spinal radiographs among individuals referred for potential IS, which may not represent a true cross-section of asymptomatic subjects. In addition, the review of radiographic imaging was limited to AP radiographs, which is known to be limited in the evaluation of the complex three-dimensional anatomy of the pelvis and proximal femur. Specific to cam-type morphology, previous studies have demonstrated that evaluation of sphericity of the femoral head is assessed best using the Dunn view.We observed a high prevalence of radiographic abnormalities potentially indicative of FAI in asymptomatic adolescents, further demonstrating that that the observed radiographic abnormalities are associated with a low level of specificity for FAI (not effective at ruling out the presence of hip pathology among asymptomatic hips). An LCE angle <25° or >40° was the most common abnormality, present in greater than one-quarter of the of hips. The results do not support sole reliance on radiographic abnormalities. However, radiographic abnormalities may be useful in predicting future hip pain. In our study, an abnormal Tonnis angle and acetabular retroversion were significantly associated with the development of future hip pain. These results support the judicious use of both clinical and radiographic factors in the treatment of FAI to avoid overtreatment.


Within the last years, single-incision laparoscopic cholecystectomy (SLC) emerged as an alternative to multiport laparoscopic cholecystectomy (MLC). SLC has advantages in cosmetic results, and postoperative pain seems lower. Overall complications are comparable between SLC and MLC. However, long-term results of randomized trials are lacking, notably to answer questions about incisional hernia rates, long-term cosmetic impact and chronic pain.A randomized trial of SLC versus MLC with a total of 193 patients between December 2009 and June 2011 was performed. The primary endpoint was postoperative pain on the first day after surgery. Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. A long-term follow-up after surgery was added.p = 0.317). No significant differences were observed in operating time or the overall rate of postoperative complications . SLC exhibited better cosmetic results in the short term. In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups.Ninety-eight patients (50.8%) underwent SLC, and 95 patients (49.2%) had MLC. Pain on the first postoperative day showed no difference between the operative procedures (SLC vs. MLC, 3.4 ± 1.8 vs. 3.7 ± 1.9, respectively; Taking into account a follow-up rate of 68%, the early postoperative advantages of SLC in relation to cosmetic appearance and pain did not persist in the long term. In the present trial, there was no difference in incisional hernia rates between SLC and MLC, but the sample size is too small for a final conclusion regarding hernia rates.DRKS00012447German Registry of Clinical Trials  Since the first laparoscopic cholecystectomy was performed by Mühe et al. in 1985, significant progress in the practice of minimal invasive gallbladder surgery revolutionized the surgical treatment of benign gallbladder diseases . Within Therefore, we performed a randomized trial to compare single-port with multiport laparoscopic cholecystectomy within the early days of single-port laparoscopy and added a long-term follow-up of the patients with particular focus on the development of incisional hernias and long-term cosmetic results.DRKS00012447). All subjects provided written informed consent prior to inclusion in the study.The study was designed as a prospective randomized clinical trial at a single institution between December 2009 and June 2011. Approval was obtained from the local ethics committee and the institutional review board. The study is registered at the German Registry of Clinical Trials . Exclusion criteria included contraindications to laparoscopy, American Society of Anesthesiologists (ASA) class IV or V, pregnancy or lactation.All patients were randomized at a 1:1 ratio to SLC or MLC procedure via the drawing of sealed opaque envelopes containing computer-generated random numbers before the start of surgery. A third party prepared the envelopes, and block sizes of two and four were used randomly and unknown to the operating surgeon.The primary outcome was the measurement of pain on the first postoperative day using a visual analogue scale (VAS). Pain scores were recorded on the morning of the first postoperative day and the day of discharge.Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. The operative time was defined as the time from the skin incision to the complete application of all wound dressings. Intraoperative complications were defined as any adverse event during the surgery that required additional intervention or treatment. Postoperative morbidity was defined as any adverse event that required additional medical or surgical intervention during the short-term follow-up and was classified according to Dindo et al. . The lenAfter an initial analysis, we added a long-term follow-up of all patients. Therefore, we added the rate of incisional hernia and cosmetic result of the long-term follow-up to the secondary endpoints.The surgical techniques for MLC and SLC were standardized. Three experienced laparoscopic surgeons, each of whom performed over 100 ML and more than 50 SIL cholecystectomies, performed or supervized all surgeries. Prophylactic antibiotic therapy in both groups consisted of single-shot cefotaxime (2 g) and metronidazole (500 mg), which were administered intravenously shortly before the skin incision. Patients for MLC and SLC were placed in a supine position with both surgeons standing on the left side of the patient.Access to the abdominal cavity for SLC procedures was achieved via mini-laparotomy through a single transumbilical 15- to 20-mm skin and fascial incision. A commercial port system  was inserted with the aid of the supplied introducer. A 30° 5- or 10-mm laparoscope and two standard straight 5-mm working instruments were inserted through the port system.The MLC was a three-port approach, and the pneumoperitoneum was established using a Veress needle. A 10-mm trocar was placed subumbilically for the 30° laparoscope, and two working trocars (5 and 10 mm) were inserted under sight epigastrically and in the middle right lateral region.Calot’s triangle was dissected in all procedures, and the cystic duct and artery were ligated using a 5-mm endoscopic clip applier  and divided with scissors. The gallbladder was carefully dissected from the fossa. The gallbladder was removed directly through the port system in SLC procedures, which also acts as a wound protector. Gallbladder extraction for MLC was done via the umbilical incision with a retrieval bag to avoid wound contamination. The umbilical and 10-mm incisions were closed using non-absorbable 0 sutures for the fascial incision and absorbable 4-0 monofilament sutures for skin closure. We did not apply local anaesthetics around the trocar incisions as pain medication.All patients received the same standard analgesia prescription during the postoperative care. This care consisted of 1000 mg metamizole intravenously three times daily for the first postoperative day and was reduced to 500 mg metamizole orally three times daily until discharge. A rescue medication of 50 mg tramadol orally was titrated up to three times daily on demand until the VAS pain score was lower than 3. Patients were discharged around the second day after surgery as soon as oral feeding was tolerated, and there were no signs of fever or uncontrolled pain.The follow-up was started in August 2016 via letter correspondence with the patients. The questionnaire included information on clinical symptoms that suggest incisional hernia, information on any other abdominal surgery after the cholecystectomy and questions about the patient’s cosmetic opinion of the scar and pain or discomfort at the scar. If no response was received by the end of 2016, patients were contacted by telephone up to three times with at least 1 week in between contact attempts. If no response was achieved, patients were counted as lost to follow-up due to no contact. All patients were asked the same questions to detect an incisional hernia according to the findings of Baucom et al. [All patient data, including clinical history, demographic factors, laboratory data, indication and details of the surgical procedure, intraoperative findings and postoperative short- and long-term outcomes, were prospectively recorded in a specific database.The hypothesis was that SLC was associated with less postoperative pain compared with MLC as measured using a VAS score. The sample size calculation was performed before the study was initiated. To identify a difference of 1 point in VAS score with an estimated standard deviation of 2, it was calculated that 84 patients were required per group with a power of 90% and a type 1 error of 5%. With the assumption of at least 10% patient loss to follow-up or dropout in each group, a total sample size of approximately 190 patients was planned for inclusion.χ2). Numerical continuous variables were compared using the Mann-Whitney U test. A p value < 0.05 was considered statistically significant. All analyses were performed using SPSS  version 23 .All analyses were based on the intention-to-treat principle, and losses were not replaced. Variables are described as numbers with percentages as appropriate or as means ± standard deviation. Categorical variables were compared using the chi-squared test (n = 129), aged 19 to 89 years (mean 47.1 years ± 15.4 years), were randomly assigned to SLC (n = 98) or MLC (n = 95) . A haematoma/seroma in the gallbladder fossa was found in two patients, two patients showed an umbilical haematoma, and one patient developed pneumonia. All of these postoperative complications were grade I or II (Clavien-Dindo). One patient reported prolonged epigastric pain and vomiting, and this patient underwent a gastroscopy without a diagnosis. However, the symptoms improved the day after the intervention. Another patient showed postoperative cholestasis with an endoscopic retrograde cholangiopancreatography that showed swelling of the ductus choledochus, and a papillotomy was performed. These two complications were classified as grade IIIa (Clavien-Dindo).Postoperative complications occurred in four patients after SLC and in three patients after MLC . The postoperative hospital stay was significantly shorter after SLC than after MLC .According to the VAS, pain was similar between the two groups on the morning of the first postoperative day Table , but it p = 0.593). The incisional hernia rates in an intention-to-treat analysis were 5.6% (4/71) after SLC and 7.8% (5/64) following MLC (p = 0.735). All hernias in both groups were found at the umbilical incision.A total of 68.4% of all patients completed the follow-up after a mean time of 70.4 months. The shortest follow-up was noted after 3 months, and the longest follow-up was 90 months after the operation. Reasons for loss to follow-up are given in Table After laparoscopic cholecystectomy had found its way into daily surgical practice, an even further minimization of surgical trauma was achieved using single-incision laparoscopy. The single incision in the navel enables a concealing of the surgical scar by taking advantage of the navel’s natural scar. However, the technique is controversial. Several studies demonstrated the safety and feasibility advantages of single-incision cholecystectomy and highlighted other benefits of this technique , 17–20. The duration of the surgery is a key parameter for comparing surgical methods. No statistically significant differences were observable in this study. While several earlier studies support this result , 20–22, The conversion rate within both groups was similar, which supports the results in the relevant literature . In contThe prolonged duration of surgery and the higher conversion rate suggests that some technical difficulties are associated with the SLC technique. Several studies examined the question of difficulty of the SLC technique and concluded that SLC produced more discomfort  and invoThe present study found no significant differences in the occurrence of intraoperative complications. Bile duct injuries are a rare but particularly feared complication in gallbladder surgery that highly impact postoperative morbidity , 35. An SLC patients in the present study had a significantly shorter hospital stay compared to MLC patients. Recent studies only partially support these results and showed a lower , 25 or eRegarding the primary endpoint of the present study, we found a tendency of less pain on the morning of the first postoperative day in the SLC group, but without statistical significance. The VAS pain score on the day of the patients’ discharge from the hospital was significantly in favour of SLC. Postoperative pain in the literature is controversial. A significant limitation in the comparability of techniques is the use of different follow-up periods and considerable heterogeneity in results and methodologies between the individual studies. Overall, the measurement of postoperative pain in the relevant literature was not standardized, and it was performed at different times. Although the benefits of SLC are not supported consistently in the literature, a trend towards lower pain levels after SLC was observed. Arezzo et al. showed significantly lower pain intensity in the SLC group, but the results in the individual studies analysed were measured at eight different time points . HaueterAnother factor in patient’s postsurgical satisfaction is their general contentment with the cosmetic result of the surgery. The relevant literature illustrates consistency in this regard and shows the benefits of the SLC technique , 23, 26.The cost-effectiveness of SLC is still a subject of ongoing debate. Two randomized trails report results regarding the cost of the operation. Bucher et al. found the cost of SLC to be higher in a Swiss trial, and Pan et al. from China report equivalent operative costs compared to MLC , 20. In The widespread view is that the greater length of the naval incision in the SLC technique increases the risk of developing an incisional hernia . VariousThere are some other possible operative alternatives to SLC regarding the minimization of the incision. Mini-laparoscopy using 3- to 5-mm trocars is a widespread alternative to standard MLC . A meta-The present study has some limitations. Neither the postoperative care surgeons nor the patients were blinded in our trial. Just recently, the Study Centre of the German Surgical Society formulated recommendations for the use of blinding in surgical trials that should be considered in future trials . AnotherThe present study demonstrates that SLC is a safe and feasible alternative to cholecystectomy in experienced surgical hands with short-term advantages in cosmetic results, postoperative pain and length of hospital stay, but the advantages regarding cosmesis and pain do not persist in the long term. Almost 6 years after surgery, no difference in pain and cosmetic scores and incisional hernia rates between SLC and MLC were noted.


Effective postoperative analgesia may enhance early rehabilitation after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone for early postoperative pain treatment after TKA.After institutional review board approval, written informed consent was obtained from patients undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 30 mL of 0.5% ropivacaine and 100 mcg of clonidine. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. The primary outcome was morphine consumption in the first 24 hours. Secondary outcomes included pain scores, morphine consumption at 48 hours, opioid-related side effects , functional outcomes, quadriceps strength, and length of hospital stay.For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.researchregistry5490 The goal of achieving an ideal analgesia modality which facilitates early rehabilitation, prevents knee stiffness, reduces hospital stay due to pain, and promotes good functional outcomes continues to be elusive. Multimodal analgesia has been devised to control postoperative pain and reduce opioid consumption including periarticular injection (PAI) and peripheral nerve blocks.,5 The adductor canal block (ACB) has recently gained popularity as an alternative to femoral nerve block due to reduced incidence of quadriceps muscle weakness. It provides a more distal nerve blockade, at the mid-thigh, ideally providing sensory blockade in the distribution of the saphenous nerve, posterior branch of the obturator nerve and vastus medialis nerve while sparing quadriceps function. Literature has supported improved motor function with similar pain control when comparing ACB to femoral nerve block.891089Femoral nerve block has been one of the most commonly used peripheral nerve blocks following TKA. However, because the femoral nerve is comprised of both sensory and motor branches, this block can lead to quadriceps weakness thus delaying mobilization and presenting an increased risk of falls.,12 and non-inferior compared to femoral nerve block.1415161415 PAI during TKA has thus been recommended for routine application considering effective pain relief and smoother rehabilitation.The PAI is a surgeon-controlled analgesic technique that used to reduce the pain in the early postoperative period with no influence on quadriceps strength. It is a mixture of medications that typically includes, but is not limited to, a local anesthetic, morphine, and Toradol. It has been shown to have superior analgesic effects compared to placebo1819201819 We, therefore, further designed a randomized controlled study to compare ACB + PAI with PAI in the treatment of TKA. For the present trial, we hypothesized that the addition of an ACB to PAI, compared with PAI alone, would reduce the time to meet discharge criteria after total knee replacement. Additionally, we hypothesized that patients receiving ACB + PAI would have significantly lower pain scores after surgery.Despite the evidence above, concerns exist regarding the incomplete analgesia of PAI. Previous studies have been published to explore the efficacy between ACB + PAI versus PAI alone in reducing pain after TKA, but with different conclusions.22.1This prospective, blinded randomized controlled trial was conducted at our single university hospital. The study was approved by the institutional review board of the hospital (CQ001023). The trial was registered with Research Registry (researchregistry5490) prior to the enrollment start. Patients were enrolled after signed written consent was obtained. All surgeons, recovery room and floor nurses, research assistants, statisticians, and patients were blinded to group allocation. Only the anesthesiologists performing the blocks and operating room nurses were not blinded.2 and an American Society of Anesthesiologists functional status of I-III were included. Exclusion criteria included a knee flexion deformity of ≥30°, varus-valgus deformity of ≥30°, a diagnosis of nonosteoarthritis , known allergy to the drugs used in this study, or a past history of opioid consumption, excessive alcohol consumption, cognitive impairment, psychiatric illness, narcotic dependency, recognized neuromuscular disorder, knee surgery (including arthroscopy and open surgery), knee infection, or thrombolytic events . Patients who had an inability to communicate verbally or who were unwilling to give informed consent were also excluded.Patients aged 50-80 years with a body mass index of 18-36 kg/m2.2www.randomizer.org) in a 1:1 ratio with 20 numbers in each block. Every participant received a consecutive study number from 1 to 69 and received the treatment assigned according to the randomization list. The list was stored and only 2 nurses, who prepared the study medications, had access to it. They had no interactions with the patients. All other clinical personnel, participants and outcome assessors were blinded to the intervention. The randomization key was first broken when all enrolled patients had completed the study. After discharge, the participant's personal information was eliminated from the study number and was therefore not traceable back to the patient  and extended-release oxycodone (10 mg). Both groups received a spinal anesthetic with 0.5% bupivacaine (10 or 12.5 mg). Patients received 4 mg of ondansetron and 20 mg of famotidine. Patients were not given intravenous opioids or ketamine. The surgeons administered a deep periarticular injection prior to cementation and a second superficial injection prior to closure. The deep injection consisted of 30 mL of 0.5% bupivacaine with epinephrine, 1 mL of 8 mg/mL morphine, 1 mL of 40 mg/mL methylprednisolone, 500 mg of cefazolin in 10 mL, and 22 mL of normal saline solution. The superficial injection was 20 mL of 0.25% bupivacaine.For ACB, an ultrasound transducer was used to identify the adductor canal. The transducer located the adductor canal at mid-thigh, halfway between the inguinal crease and patella. Superficial femoral artery, sartorius muscle, adductor longus muscle, and adductor magnus muscle were identified. The hyper echoic structure located anterolateral to the artery  was identified as the target injection site. A 22-guage, 100 mm needle was introduced lateral to medial under ultrasound guidance using linear probe of a sonosite machine. Solution containing 30 mL of 0.5% ropivacaine and 100 mcg of clonidine was injected after ensuring correct placement of the needle.2.4Patients in both groups received 1 session of physical therapy on the day of the surgical procedure and 3 sessions at 24 and 48 hours until they achieved discharge criteria. Patients defaulted to 2 physical therapy sessions if they did not meet discharge criteria by 72 hours. Each rehabilitation session assessed patients for discharge. The criteria for discharge were the ability to independently transfer in and out of a bed, chair, or toilet seat; to walk approximately 50 m with or without an assistive device; to negotiate stairs with or without a rail or cane; and to perform a home exercise plan. All subjects underwent a standard postoperative multimodal pain management regimen. Postoperative medications included acetaminophen, ketorolac followed by celecoxib (for 3 months), gabapentin (standing order for 10 days), oral opioids (as needed), and intravenous hydromorphone for breakthrough pain.2.5The primary end point was Morphine consumption in the first 24 hours (including Morphine administered intra-operatively and in recovery). Secondary outcomes included pain scores, Morphine consumption at 48 hours, opioid-related side effects , functional outcomes, quadriceps strength, and length of hospital stay. Pain scores were recorded at 1, 6, 12, 24, and 48 hours post-operatively, using a Numerical Rating Scale (0–10) at rest and during 45° passive flexion of knee.Nausea was defined as the unpleasant sensation associated with awareness of the urge to vomit; vomiting was defined as the forceful expulsion of gastric contents from the mouth. The presence/absence of nausea and the number of episodes of vomiting (more than 10 mL) were recorded. The usage of antiemetics was also recorded. The level of sedation was assessed on a 4-point scale .Functional outcome measures used were the 30 Seconds Chair Stand Test (30-CST) and the Timed Up and Go (TUG) test. 30-CST tested the number of times each subject was able to stand up from a seated position on a chair in 30s. The TUG test assessed the time taken for each subject to get up from a seated position on the chair, walk 3 meters away from the chair before returning to it. Both 30-CST and TUG test had been shown to be reliable and validated tools for rehabilitation of orthopedic patients. Quadriceps strength was assessed as a percentage of the baseline measurements at 24 and 48 hours post-operatively, using the method previously described. The 30-CST and TUG tests were performed at 24 and 48 hours. We also assessed for early complications such as hematoma, infection and neurological deficits at 48 hours. Any other early complications, including falls within the first 48 hours were recorded. The length of hospital stay was also noted.2.6The sample size calculation was based on a pilot study that we conducted on 18 patients (whose data were not included in the present study). In this prior study, the mean difference and standard deviation of the Numerical Rating Scale scores 24 hours after the operation between the ACB + PAI and PAI groups were 0.40 and 0.19, respectively. From this, it was determined that 42 subjects would be required to reach an α value of 0.05 and a power of 85%. It was estimated that the attrition rate due to canceled surgery or reasons of late patient ineligibility could be up to 20% and, therefore, to account for this, the final sample size selected was n = 100 (50 per group).2.7U variance analysis was used for discrete numerical variables that did not show normal distribution. Relationships between the categorical variables were determined by preparing crosstabs and using the Chi-squared (χ2) test. P < .05 was accepted as statistically significant.The statistical analyses in this study were performed using the Statistical Package for the Social Sciences ) 20.0 software. Continuous variables were presented in the form of mean ± standard deviation or error. The Kolmogorov–Smirnov normality test was used to assess continuous variables. Group comparisons on the variables that showed normal distribution were performed using one-way analysis of variance. Mann–Whitney 334534 Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation, and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia.TKA is a common surgical procedure that can cause severe postoperative pain. Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block, and local anesthetic infiltration analgesia.,21 Moreover, PAI has been shown to improve pain management and to preserve motor function. With PAI, the nerves, muscle, and tissue in the posterior, lateral, and medial aspects of the knee are infiltrated intraoperatively with local anesthetic, morphine, and ketorolac to provide analgesia.The introduction of ACB to manage pain after TKA is relatively new. The adductor canal is an aponeurotic space in the middle third of the thigh. It contains nerve branches that supply sensory innervation to the knee, including the posterior branch of the obturator nerve and the saphenous nerve. Blocking these nerves provides analgesia to the medial aspect but not to the lateral or posterior aspects, of the knee.The main limitation of the current study was the inability to blind both the participants and the physicians to comparisons between peripheral nerve blockade and periarticular injection. This lack of blindness may have introduced some risk of bias from both the patients and the physicians. The outcome assessments from the adjudicators and all the statistical analyses were conducted in a blinded manner. In addition, the impossibility of measuring quadriceps muscle power before and after the operation using special instruments was another limitation. If this had been possible, the evaluation between the ACB + PAI and the PAI groups could have been more objective.Conceptualization: Yongcheng Ren.Data curation: Yongcheng Ren.Formal analysis: Yongcheng Ren.Funding acquisition: Jianming Yang.Investigation: Xiaoyan Qin, Jiacai Liao.Methodology: Xiaoyan Qin, Jiacai Liao.Resources: Jianming Yang.Software: Xiaoyan Qin.Supervision: Jianming Yang.Validation: Xiaoyan Qin.Visualization: Jianming Yang.Writing – original draft: Yongcheng Ren.Writing – review & editing: Yongcheng Ren, Jianming Yang.