Early rehabilitation, return to daily life activities and function are the ultimate goals of perioperative care. It is unclear which pain-related patient-reported outcome measures (PROM) mirror treatment effects or are related with early and late functional outcomes.We examined associations between two approaches of pain management (scheduled vs ‘on demand’) and PROMs on post-operative days one and five  with function on POD5 and 3 months after surgery in patients undergoing Total Knee Arthroplasty (TKA) in a single centre. The scheduled pain management consisted of pain assessment and routine administration of non-opioid drugs, and a weak opioid based on severity of pain reported by patients. The ‘on demand’ group received non-opioids and/or a weak opioid only when asking ‘on demand’ for analgesics.On POD1, patients in the scheduled treatment group reported reduced severity of worst pain, less interference of pain with activities in-bed and sleep, and a higher proportion got out of bed. On POD5, these patients reported as well significantly less worst pain, spent significantly less time in severe pain, experienced less interference of pain with activities in bed, and felt less helpless. Furthermore, tests of function, extension and flexion ranges, Barthel index and 6 minutes walking test on POD5, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) 3 months later were significantly better in the scheduled treatment group compared to the ‘on demand’ treatment group. Pain related PROMs assessed at POD1 and especially at POD5 are associated with better knee range of motion, better performance in activities of daily living, and faster gait speed, as well as less pain, better performance in activities of daily living, as well as higher knee-related quality of life 3 months postoperatively.Our study demonstrates that severe postoperative pain after TKA might have long lasting consequences, and even small improvements in treatment, although being far from optimal, are accompanied by improved outcomes. Orthopaedic procedures on the extremities can result in severe postoperative pain . Severe investigate the impact of two different levels of postoperative pain management on pain-related PROMs and established function scores up to 3 months after TKAstudy the association between pain-related PROMs on postoperative days 1 and 5  and functional scores obtained at POD5 and 3 months after surgeryEthics Committee board of the Clinical Center of Serbia (Number 2017-004244-37). Patients were included in the study after they have signed a consent form, explaining that the study aims to improve pain treatment of patients after TKA in the future, and confirming that no changes were made in the standard medical care at the moment. The study was carried out over a 6 month period.All adult patients ≥ 18 years with knee osteoarthritis scheduled for total knee replacement who were consecutively admitted to the Clinic for Orthopaedic Surgery and Traumatology, Clinical Center Serbia in Belgrade between January 2016 and July 2016 were enrolled in an open prospective observational cohort study. This was a prospective observational study. The study was carried out in accordance with the principles of the Helsinki Declaration and approved by the Consecutive patients with knee osteoarthritis who underwent TKA were approached on the first day after surgery (POD1) for recruitment. Patients meeting the following inclusion criteria were asked the join the study: 1) older than 18 years of age; 2) able to communicate; (3) gave written consent.The indication criteria for TKA were based on a hospital used scoring system taking into account pain, function, radiological changes, and failed conservative treatment. Total knee arthroplasty was performed by one of four different experienced surgeons with insertion of tricompartmental prostheses using a standard medial parapatellar approach. Cruciate-substituting designs were used. Surgery was performed in a bloodless field using a femoral tournequet 300 mmHg. At the end of the surgery a compression bandage from the toes to the mid-thigh was applied. Spinal anesthesia was performed with the patient in a sitting position. Levobupivacaine 0.5% 3 ml was injected into the subarachnoid space throught the L3-4 intervertebral space via midline approach. General anesthesia was induced with midazolam 0.05mg/kg, fentanyl 3 mcg/kg, propofol 1.5–2.0 mg/kg, and cisatracurium 0.2mg/kg. Anesthesia was maintained with sevoflurane 1MAC. No local infiltration anesthesia has been used in our study group. Postoperatively, in the recovery room, all patients received Ketorolac 30 mg/day intravenously, and Tramadol 400 mg/day.All patients followed a standardized postoperative rehabilitation program beginning on the first postoperative day. Assisted ambulation and regular exercise to restore strength and mobility of the operated knee were performed 2 times a day for 20–30 minutes.After surgery, patients were assigned to one of two wards, depending on availability of a free bed. This assessment method mirrors the clinical routine in our hospital, and it determined the pain treatment strategy that patients received. The routine treatment protocol on one ward consisted of pain assessment and routine administration of non-opioid drugs  based on severity of pain reported by patients (= scheduled pain control group). The WHO stepwise approach to the use of analgesics depending on pain severity was applied. Pain was assessed at least once per shift. On the second ward, patients received non-opioids  and / or a weak opioid (Tramadol) only when they experienced pain, and after asking the attending physician or nurse for analgesics. Drugs were given according to the pain score. Pain was not routinely assessed (= ‘on demand’ pain control group). Both regimens were applied on all days from POD1 to POD5. The medications were administered intravenously. Patient controlled analgesia or co-analgesics were not given to patients on either ward.demographic and clinical data comprising variables such as gender, age (year of birth), weight and height, administration of opioids before admission and analgesics perioperatively, and type of anesthesia. The assessment was carried out in patients who were at least 6 hours in the ward. Preoperative functional status was assessed with the Knee Injury and Osteoarthritis Outcome Score (KOOS) [International Pain Outcomes Questionnaire (IPO-Q) [On POD1, assessment included e (KOOS) . The KOO (IPO-Q) . The IPOFunctional assessment was carried out on POD5, consisting of knee range of motion, Barthel index and 6 minute walking test)  and at 3In this study, we aimed to answer the following questions:Is there an impact of two different levels of postoperative pain management on PROMs, and functional scores up to 3 months after TKA, and are PROMs obtained on POD 1 and 5 associated with functional outcomes 5 days and 3 months after surgery.Continuous variables are presented as mean values with standard deviation, while categorical values are summarized as absolute frequencies and percentages. Bivariate analyses were conducted to compare patient characteristics in independent groups via Students’ T test for continuous variables, and Chi squared statistics for categorical variables. Pearson correlation coefficients assess the strength and direction of the linear relationships between pairs of variables. A p value < .05 was considered statistically significant. All analyses were performed using SPSS 22.0.According to the post-hoc computing for the chosen error of the first type 0.05, effect size of 0.8, and sample sizes n1 = 28 and n2 = 32 for the main outcome („worst pain“) the study power was 85.99%. This calculation was done in GPower 3.1.Sixty patients were recruited to the study. The ‘‘on demand’ group consisted of 28 patients, of which 46% were female, with a mean age (± SD) 66.4± 6.9. Thirty-two patients were included in the scheduled pain control group, of which 50% were female, with a mean (± SD) age of 64.4 ± 9.8 years. The groups did not differ with regards to gender and age. The vast majority of patients in both groups suffered from chronic pain (pain lasting ≥3 months) in the knee. No differences were observed with respect to the incidence of chronic pain, nor its intensity between the groups. None of the patients received opioids before admission to hospital. Patients in both groups did not differ with respect to their preoperative functional status assessed with the KOOS score, nor time on the waiting list .In the scheduled treatment group, 14 (37.0%) of patients were operated under general anesthesia (GA) and 28 (67.0%) were operated under regional anesthesia (RA). In the ‘on demand’ group, 15 (53.6%) underwent GA and 14 (46.4%) had RA. There was no difference between the two groups with respect to the proportion of GA vs. RA.In the scheduled pain control group, all 32 patients received non-opioid analgesics on POD1, in the ‘on demand’ pain control group it was 14 (50%) patients. An opioid, in the form of tramadol, was administered to 17 patients (53.1%) in the scheduled pain control group, and to 8 (28.6%) patients in the ‘on demand’ control group (p<0.01) see .PROM measured at POD1 and POD5 differed significantly between the two groups. Patients in the scheduled pain control group reported significantly less worst pain, less interference of pain with activities in-bed, and felt less helpless. Additionally, on POD1, a higher proportion of these patients got out of bed, pain interfered less with sleep, they perceived more pain relief, were more satisfied with their pain treatment, reported that they received more information about possibilities of pain treatment, and fewer wished for more analgesics. On POD5, these patients reported spending significantly less time in severe pain see .On POD5, all observed functional outcome measures, knee extension deficit and flexion, Barthel score, as well as 6 minute walking test were significantly better in the scheduled pain control group. The differences between the two treatment groups regarding early functional outcome were most pronounced with respect to ambulation. Patients in the group with scheduled pain control group had a highly significant faster gait speed on POD5 as measured with the 6 minute walking test see .At 3 months postoperatively, the KOOS subscales for pain, activities of daily living and quality of life were significantly better in the scheduled pain group see .Our results revealed weak but statistically significant associations between pain related PROMs on POD1 and functional outcome parameters on POD5 and 3 months postoperatively. Severity of ‘worst pain’, “proportion of patients out of bed” and “percentage of pain relief” on POD1 correlated with the Barthel score on POD5. “Least pain” on POD1, as well as “feeling of helplessness”, “anxiety”, and “percentage of pain relief” correlated with the degree of knee flexion on POD5. Percentage of pain relief and participation in decisions regarding pain treatment correlated significantly with the 6 minute walking test at PO5 see .The pain intensity sub-score of KOOS at 3 months postoperatively correlated with the frequency of severe pain and percentage of pain relief on POD1. The quality of life sub-score 3 months postoperatively was also related to the percentage of pain relief assessed on POD1, while independence in performing ADLs 3 months postoperatively correlated with pain interference with in-bed activities and satisfaction with pain treatment on POD1 see .Significant relationships were also observed between pain related PROMs on POD5 and functional outcome measures assessed on POD5 and 3 months postoperatively. Patients who were mobilized out of bed in the last 24 hours, and felt less helpless on POD5 performed better regarding the Barthel score on POD5. Furthermore, patients who had lower scores for worst and least pain, lower frequency of severe pain, and who were more involved in pain decisions on POD5 achieved higher range of motion in terms of flexion on POD5. Pain interference with activities out of bed was related with a higher extension deficit on POD5, while patients who felt anxious on POD5 performed worse on the 6 minute test on POD5 see .Moreover, a number of IPO-Q items on POD5 correlated significantly with functional outcome 3 months later, specifically worst pain, time in severe pain, interference with activities and participation in treatment see .This study investigated the impact of two different levels of postoperative pain management on pain-related PROMs and established function scores up to 3 months after TKA and the association between pain-related PROMS and functional recovery scores at different time points, up to 3 months after surgery in patients undergoing TKA. Pain management was not optimal on either ward in that patients reported moderate to severe pain, they spent on average 36–43% of the first postoperative day in severe pain and many would have wanted more treatment for pain than they received. However, administration of higher doses of analgesics in the scheduled treatment group were associated with reduced pain-related PROMs and improved early functional outcome during the first days after surgery. This treatment regimen was also related with positive effects on pain and function lasting for at least 3 months postoperatively. A number of pain-related PROMs obtained early after surgery were associated with functional outcome measures at POD5 as well with the KOOS score 3 months postoperatively. Generally, several understandings emerge from the correlation analysis. First, the PROM "percentage of pain relief" measured on POD1 correlated with the largest number of outcome measures on POD5 and 3 months postoperatively. Its predictive value could, thus, be further investigated in future multivariate regression analyses. Second, PROMs assessed on POD5 had higher predictive values with short and long term rehabilitation outcomes as compared to PROMs obtained on POD1. Therefore, a critical evaluation of PROMs and function several days after surgery might identify patients at risk for worsened functional outcome later on. Third, the PROMs reported on POD5 that showed the largest number of correlations with observed functional outcome measures were "worst pain", "time in severe pain", and "participation in decisions about pain treatment options".Our study demonstrated that decreased pain management immediately after TKA might have long lasting consequences, and even small improvements in treatment, although being far from optimal, are accompanied by improved outcomes. Therefore, effective pain management is of utmost importance. Our findings reinforce the need for providing adequate pain management. There is considerable evidence from literature describing the benefits of effective analgesia on PROMs, better knee function, and better walking ability in the early postoperative period –9, 11. IThere is an increasing debate as to the role of PROMs in the area of acute pain management. Pain intensity alone may not to be an ideal measure of quality of care, and it is unclear if and to what extent it mirrors functional capabilities. Van Boeckel at al. recently showed that pain intensity did not correlate well with patient’s opinion on acceptability of pain, nor with nurses’ observation of patient’s performance of necessary activities . HoweverOur study is associated with several limitations. This was not a randomized trial. We cannot claim that selection bias was eliminated though the principle difference between the two groups was that patients were allocated to one of the two wards, and this depended on availability of a bed. We only studied a small number of patients in a single center with lack of health care personnel, including potential surveyors. In our study only one surveyor collected patient-reported outcome data as well as clinical data in a highly standardized way using the IPO-Q questionnaire and inputted the data into the webbed data entry mask, which is a very time consuming process. Therefore, we were forced to limit the study investigation period to 6 months, and consequently include a relatively small number of patients. Larger sample sizes in other studies were the same IPO-Q questionnaire was used were obtained by gathering datasets from multiple hospitals in different countries . FurthemOur study is novel in that it was carried out in a low-resource country, and mirrors reality of management in a low resource setting, with limited education and awareness regarding pain therapy. It might be considered to be ethically questionable to expose patients to a setting with known suboptimal care patients. However, patients would not have been treated differentially without this study, and the results would not have been reported. Therefore, we hope that findings such as ours will encourage other care givers working in similar conditions to evaluate outcomes of patients they care for. Our study also illustrates that standardized data collection offers an indispensable tool for bringing to light information about PROMS and approaches for managing pain.Although quality of pain management in patients evaluated in this study is different from standards reported in high resource countries, we showed that even slightly increased pain management translates in reduced severity of pain and in improved functional outcomes. Availability of information about deficits in care can serve as a catalyst for providers to bring about change. Moreover, early PROMs can be used to detect patients at increased risk for delayed functional recovery after TKA. These conclusions should motivate care givers to improve the perioperative pain management they provide to their patients after TKA.S1 Raw data(XLSX)Click here for additional data file.


Material and Methods. A structured interview was used to identify and characterize pain in a cohort of 260 consecutive PD patients. The Ford classification of pain was applied. The Dementia Rating Scale-2 (DRS-2) and the Impulse Control Disorders in Parkinson's Disease Short Form (QUIP-S) were administered, and patients' smoking habits were recorded. The Unified Parkinson's Disease Rating Scale (UPDRS) was used to assess motor and nonmotor symptoms in off and on conditions.  Pain is a major nonmotor symptom of Parkinson's disease (PD), and central parkinsonian pain is the core feature of the putative Park pain subtype of PD. This study aimed to explore the cognitive and behavioral profile of PD patients with central parkinsonian pain. Discussion. The study results provide further evidence that pain revealed that patients with central parkinsonian pain are more likely to present compulsive or addictive behaviors, despite having more preserved cognitive performance. Patients with central parkinsonian pain appear to have a distinct phenotype of PD. One hundred and eighty-eight patients (68%) reported pain; and in 41 (22%) of them, the pain was classified as central parkinsonian pain. PD patients with central parkinsonian pain had better cognitive performance in DRS-2 Initiation/Perseveration and Conceptualization subscales but reported more other compulsive behaviors  and had more current smoking habits than those without pain or with non-central parkinsonian pain. Multiple logistic regression analyses revealed that the DRS-2 Conceptualization subscale, other compulsive behaviors, and smoking habits remained statistically associated with central parkinsonian pain even when other significant covariates were considered. Only patients with pain, regardless of type, had a gambling disorder.  Parkinson's disease (PD) is a complex neurodegenerative disorder that includes motor and nonmotor symptoms, such as dementia, sleep disorders, autonomic dysfunction, sensory, and psychiatric symptoms . It has on, more pain‐related disability, more sleep disturbances, and more relief of pain with antiparkinsonian medication than patients with non‐central parkinsonian pain . All patients were asked whether they had pain in the last month. Those who responded “yes” to the previous question were asked a series of questions regarding their pain. Based on the patients' description, the neurologists categorized the pain, according to the Ford framework [A movement disorders specialist performed a semistructured interview  and a nDRS-III) . After tramework , as centramework , as burnramework , 14. Paton condition).A trained neuropsychologist applied the Portuguese version of the DRS-2 . Test scp < 0.05. Multiple logistic regressions explored group differences while considering relevant covariates. The backward selection method was applied with a threshold for variable removal of p > 0.100. The statistical analysis was conducted using the Statistical Package for the Social Sciences, version 25.0 .Descriptive statistics were used for group characterization and nonparametric tests  were applied for group comparisons. The threshold for statistical significance for group comparisons was Of the 260 PD patients who were examined, 135 (52%) were men and 125 (48%) were women, with median age = 70 years, education = 4, age at disease onset = 60 years, and disease duration = 7 years. At the time of the assessment, 188 patients (68%) reported pain. Of those with pain, 41 (22%) had central parkinsonian pain and 147 (78%) had non-central parkinsonian pain. The demographic and clinical characteristics of the subgroups are presented in p=0.002 and p=0.011, respectively) and at assessment (p=0.001 and p=0.002 respectively) and were taking more dopamine agonists  . PD patients with central parkinsonian pain had greater UPDRS-II levodopa responsiveness than patients with non-central parkinsonian pain (p=0.001), and the responsiveness was higher than patients without pain although the level of statistical significance was marginal and nonsignificant (p=0.063).As compared with patients without pain and patients with non-central parkinsonian pain, PD patients with central parkinsonian pain were younger at disease onset (ctively) . Patientp=0.028; and 22%, p=0.005, respectively) or with non-central parkinsonian pain . No significant differences were found regarding DRS-2 Total score, Attention subscale, Construction subscale, and Memory subscale. Multiple logistic regressions revealed that patients with central parkinsonian pain had lower odds of having deficit on DRS-2 Conceptualization than patients without pain  or patients with non-central parkinsonian pain , when considering age, age at disease onset, agonist medication, and UPDRS-II levodopa responsiveness as covariates. The association between deficit on DRS-2 Initiation/Perseveration and central parkinsonian pain was no longer statistically significant when the same covariates were considered.PD patients with central parkinsonian pain had fewer deficits on DRS-2 Initiation/Perseveration (12%) and Conceptualization (2%) subscales than patients without pain  and in patients without pain although the level of statistical significance was marginal and nonsignificant . The odds of having other compulsive behaviors were higher for patients with central parkinsonian pain than those with non-central pain , when considering age, age at disease onset, agonist medication, and UPDRS-II levodopa responsiveness as covariates. No patient without pain reported compulsive gambling, whereas 7% of patients with central parkinsonian pain or non-central parkinsonian pain had this ICD. No other specific ICDs were related to central parkinsonian pain.The frequency of positive symptoms on QUIP-S was not statistically different between patients with central parkinsonian pain (29.3%) and patients without pain (18.1%) or with non-central parkinsonian pain (25.2%). Though, the frequency of other compulsive behaviors  was higher in patients with central parkinsonian pain (20%) than in patients with other subtypes of pain  or those with non-central parkinsonian pain . The odds of having current smoking habits were higher for patients with central pain than patients without pain , though the level of statistical significance was marginal and nonsignificant when age, age at disease onset, agonist medication, and UPDRS-II levodopa responsiveness were considered. The comparison with patients without pain was no longer statistically significant when the same set of covariates were considered.PD patients with central parkinsonian pain (12%) had more current smoking habits than patients without pain  than in the general population (0.25–2%) . Though,The pathological mechanisms of ICDs in PD are not yet fully understood, but it has been argued that in PD, the dysregulation of two important dopaminergic circuits—the mesolimbic and mesocortical pathways—leads to the clinical manifestation of impulsive and compulsive behaviors . In accoPatients with central parkinsonian pain were younger, took more dopamine agonists, and presented greater responsiveness to levodopa on activities of daily living (as measured by UPDRS-II) than patients without pain or with other types of pain. It can be argued that the behavioral and cognitive features of patients with central parkinsonian pain can be explained, at least in part, by these demographic and clinical characteristics of the patients. In other words, the associations between pain and other nonmotor symptoms may reflect shared protective and risk factors, in addition to possible common pathophysiological mechanisms. Supporting this hypothesis is the reported association between poor quality of sleep and both central parkinsonian pain  and ICDsa priori exclusion of patients under advanced therapies for PD, namely deep brain stimulation, which reduces the representativeness of the sample, especially in the advanced stages of the disease. The QUIP-S and DRS-2 are recommended by the International Parkinson's and Movement Disorder Society [One major strength of this study is the diagnosis of PD and the clinical evaluation by movement disorders specialists, which reduces the risk of misdiagnosis, and the neuropsychological evaluation was performed by an experienced neuropsychologist in the assessment of PD patients. The limitations of the study include the  Society  to screeIn summary, patients with central parkinsonian pain are more likely to present certain compulsive and addictive behaviors than patients without pain or those with non-central pain, even though they appear to have more preserved cognition. These findings provide support to the existence of a Park pain phenotype.


The interlaminar windows of all patients were narrow . Percutaneous laminoplasty and endoscopic interlaminar discectomy surgery were undergone by all patients from July 2018 to July 2019. All operations were completed under local anesthesia. The target laminoplasty area was the safety zone, use of which avoids both transverse and exit nerve roots. Under fluoroscopic guidance or clear endoscopic visualization, the trephines were used to enlarge the interlaminar window, which allowed the working cannula to enter the spinal canal but avoid nerve roots and the dural sac. The preoperative/postoperative visual analogue scale (VAS) scores and Oswestry disability index (ODI) were statistically analyzed. The modified MacNab criterion was used to assess the clinical effects. The radiological outcomes were evaluated by MRI and CT. SPSS 19.0 software was used for the statistical evaluation.Fifteen LP < 0.001) and the average VAS‐Leg score was reduced from 7.53 ± 1.69 to 1.47 ± 0.92 (P < 0.001). The average ODI scores improved from 47.87 ± 11.41 to 12.93 ± 3.24 (P < 0.01). According to the modified MacNab criteria, 11 cases achieved excellent results and 4 cases achieved good results. All of the operations were successful. There wertr no nerve root injuries, dural tears, or other complications.The operative time ranged from 70 to 120 min, with a median time of 92 min, and the fluoroscopy times ranged from 8 to 12, with a median of 9.7 times. The body mass index (BMI) of patients ranged from 18.10 to 26.06, with a median of 22.04. All patients were followed up in the outpatient department for at least 12 months after surgery. At the last follow up, the average VAS‐Back score of the study patients was reduced from 5.33 ± 2.09 to 2.00 ± 1.20 (The laminoplasty approach for PEID provides a safe and useful alternative for the treatment of L5–S1 LDH patients with a narrow interlaminar window. The authors used an innovative method to more safely and effectively perform PIED on LDH patients with L5–S1 with a narrow interlaminar window. Lumbar disc herniation (LDH) is a common cause of lower back and leg pain, which results in medical and economic burdens for families and society. Due to the modern sedentary lifestyle, the incidence of LDH is increasing. When expectant treatment fails, surgical treatment is often required, which may by open surgery or minimally invasive surgery. Open lumbar discectomy often leads to iatrogenic damage of the facet joints and paraspinal structures, causing muscle denervation and atrophy, segmental instability, and long‐term lumbodorsal muscular pain postoperatively. These factors seriously affect the clinical curative effect and patient satisfaction.5S1 level, PEID, which can escape the blockade of crista iliaca, has advantages over PETD, including reducing the difficulty of puncture, a faster puncture orientation, a shorter operation time, and less intraoperative radiation exposureWith the rapid development of minimally invasive spine surgery, the technique of spinal endoscopy has made revolutionary progress, especially for percutaneous endoscopic lumbar discectomy (PELD). The application of PELD has many advantages, including reduced paraspinal muscle trauma, minimal postoperative instability, lower blood loss, smaller surgical wound, and faster recovery5S1 segment because the interlaminar window is the widest5S1 level  to evaluate the feasibility of this new approach; and (iii) to determine the safety and effectiveness of this new strategy.In this study, the aims were: (i) to introduce PEID 5S1 LDH confirmed by CT and MRI; (iii) the anterior–posterior X‐ray image confirmed the narrow interlaminar window at L5S1 level; and (iv) standard conservative treatment for at least 3 months had failed to relieve recurrent pain.The inclusion criteria were as follows: (i) low back pain and history of sciatica; (ii) L5S1 level; (iv) the anterior–posterior X‐ray image determined patients who were able to accept conventional PELD for L5S1 level.The exclusion criteria were as follows: (i) radiographic findings were not consistent with patients’ symptoms or signs; (ii) multiple level disc herniation, far lateral disc herniation, foramen stenosis, lumbar instability, or cauda equina syndrome; (iii) previous surgery history for L5S1 LDH patients  with a narrow interlaminar window who accepted our novel approach at The Second Affiliated Hospital of Nanchang University from July 2018 to July 2019 were included in the present study. Written informed consent was obtained from all patients. The study was approved by the Ethics Committee of the Second Affiliated Hospital of Nanchang University.Based on the inclusion and exclusion criteria, 15 LPatients were placed in the prone decubitus position on a radiolucent operating table. Local anesthesia and intravenous sedation were chosen for this strategy. The patients communicated with the surgeon throughout the procedure.The skin was marked under fluoroscopic guidance. The target point was the safety zone Fig. . The skiLaminoplasty was performed using the trephine to enlarge the interlaminar window. The trephine should be advanced with careful rotation under fluoroscopic guidance Fig.  or clearThe working channel was then introduced Fig. , and theAfter confirmation of the structures under clear endoscopic visualization, the herniated disc was removed using various graspers Fig. . The neuThe operation time and fluoroscopy times were documented. Complications during and after the operation were recorded to evaluate the safety of the surgery. The 10‐point visual analogue scale (VAS) was adopted to assess back pain (VAS‐Back) and leg pain (VAS‐Leg) at the following time points: preoperation, 1st postoperative day, 3rd postoperative month, and 12th postoperative month. The Oswestry disability index (ODI) was used to evaluate patient functional status at the following time points: preoperation and at the 12th postoperative month. The modified MacNab criteria at the 12th postoperative month was recorded to evaluate the early clinical efficacy. Assessments were performed by an independent observer.via laminoplasty according to age, gender, BMI, left/right intervertebral disc herniation, and the length of the operation.In this study, subgroup analysis was applied to evaluate the effectiveness of the PEID The VAS score system has been widely used in recent research to assess lower back pain. The VAS score system (score from 0 to 10) is calculated as: 0 means painless; 1–3 indicates mild pain that the patient can tolerate; 4–6 indicates that the patient is in pain that could be tolerated and is able to sleep; and 7–10 indicates that the patient has severe pain and is unable to endure the pain.The ODI has been widely used to assess patients’ disability as a result of lower back pain. The ODI score system includes 10 sections: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. For each section of six statements, the total score is 5. Intervening statements are scored according to rank. If more than one box is marked in each section, the highest score is taken. If all 10 sections are completed, the score is calculated as follows: total scored out of total possible score × 100. If one section is missed (or not applicable) the score is calculated as: ) × 100%. Scores of 0%–20% are considered mild dysfunction, 21%–40% is moderate dysfunction, 41%–60% is severe dysfunction, and 61%–80% is considered a disability. For cases with scores of 81%–100%, patients are either long‐term bedridden or exaggerating the impact of pain on their life.The modified MacNab criteria were used to evaluate the surgical outcomes: excellent means no pain and no restriction of movement, so that the patient can work normally; good means occasional pain, so that the patient can work normally; fair means slight progress; poor means no progression.t‐test was used to compare the continuous variables, such as VAS‐Back, VAS‐Leg, and ODI scores, between different time points. A positive significance level was assumed at a P‐value of less than 0.05.All data were statistically analyzed using SPSS software . Continuous variables were presented as mean ± standard deviation. Student's The laminoplasties were successful completed and all patients received significant pain relief after the surgery. The operative time ranged from 70 to 120 min, with a median time of 92 min. The average fluoroscopy times was 9.7 times.All 15 patients were followed up for at least 12 months.VAS‐Back score. The average VAS‐Back score was reduced from 5.33 ± 2.09 to 2.00 ± 1.20 (P < 0.05) at the last follow up.VAS‐Leg. The average VAS‐Leg score was reduced from 7.53 ± 1.69 to 1.47 ± 0.92 (P < 0.05) at the last follow up.ODI scores. As for functional improvement, the average ODI scores improved from 47.87 ± 11.41 to 12.93 ± 3.24 (P < 0.05) at the last follow‐up.MacNab criteria. According to the modified MacNab criteria, 100% of patients (11 excellent and 4 good) had an excellent or good recovery and no poor result was reported.Complications. With respect to complications, no nerve root injuries, dural tears, lamina fractures, infections, or intraspinal hematomas were observed.No recurrence was observed at follow‐up. No significant differences were found in the subgroup analysis Table .Case one. A 36‐year‐old man was admitted to our department for severe left leg radicular pain of nearly 4 months. This patient was diagnosed with L5S1 LDH with a narrow interlaminar window. The laminoplasty was made and a herniated mass was completely removed during the PEID surgery. This patient received immediate pain relief and was discharged from hospital on the 3rd postoperative day. During the follow up, the functional improvement was satisfactory  had obtained excellent or good recovery at the last follow up. Therefore, our study showed that PEID 5S1 LDH with a narrow interlaminar window, and our results demonstrated that this strategy was effective and safe.Some limitations should be considered when interpreting our data. The retrospective design might lead to selection bias and the small sample size might reduce the stringency of our results. In addition, there was no comparison with other surgical techniques in this study. Therefore, we should further validate this novel approach in clinical trials, including prospective and multiple‐center studies. However, it should be noted that we aimed to introduce a new endoscopic discectomy strategy for the treatment of L5S1 LDH with a narrow interlaminar window.The laminoplasty approach for PEID provides a safe and useful alternative for the treatment of L


We aimed to study the differences in perception of pain during cardiac catheterization with midazolam monotherapy compared to the current standard of midazolam plus fentanyl.  Procedural sedation is important to ensure comfort and safety in patients undergoing left heart catheterization. Despite the widespread use of midazolam and fentanyl for procedural sedation, the effectiveness of this dual agent approach to sedation has never been studied in comparison to midazolam monotherapy. n = 69) or combination of midazolam and fentanyl (n = 60). The primary outcome was assessment of pain perception prior to discharge by patient completion of a pain questionnaire. Participants were asked if they experienced any pain during their procedure (yes/no) and, if yes, asked to rate their overall pain level using a 10-point Likert scale that ranged from 1  to 10 (worst pain imaginable).  A total of 129 patients undergoing sedation for outpatient elective cardiac catheterization were randomly assigned to either midazolam monotherapy  reported no pain during their procedure. Patients sedated with midazolam monotherapy reported similar average pain scores compared to patients sedated with the combination of midazolam and fentanyl .  Most patients ( Among patients undergoing elective cardiac catheterization, no significant differences in pain scores were noted between sedation with midazolam alone compared to midazolam and fentanyl. Due to fentanyl's unfavorable interaction with P2Y12 agents, increased costs, and addiction potential, it is imperative that cardiologists revisit the role of effective procedural sedation with a single agent and avoid the use of fentanyl. The administration of procedural sedation is a common practice to promote safety and ensure patient comfort during cardiac catheterization procedures , 2. The Opioids have been the cornerstone of analgesia for both chronic and acute pain since the late 1980s as part of a push by the Joint Commission to label pain as “the fifth vital sign” , 11. In In addition to the potential for opioid abuse, the use of opioid medications may interfere with the absorption of P2Y12 inhibitors due to delayed gastric emptying. Rapid absorption of P2Y12 inhibitors is critical for patients with acute coronary syndrome and patients undergoing percutaneous coronary intervention to prevent acute stent thrombosis , 20. TheSeveral small studies have demonstrated adequate sedation for catheter-based procedures with either minimal sedation or benzodiazepine monotherapy –24. The This is a single-center, single-blinded randomized prospective study performed at the University of Tennessee Medical Center, Knoxville, TN, USA. The study was approved by the institutional review board (IRB).Patients aged 18 years and older who were referred for outpatient elective cardiac catheterization (CC) including left heart catheterization (LHC), right heart catheterization (RHC), and LHC with coronary angiography from July 2019 to September 2020 were eligible for inclusion in the study. Patients were excluded if they had a known allergy to one or both of the study medications.n = 69) and midazolam plus fentanyl (n = 60). The randomization sequence was computer generated and concealed in sealed opaque envelopes. Patients, but not CC operators, were blinded to the study medications. Patients in the midazolam group were given intravenous midazolam with dosages based on age, gender, and body mass (0.5–4 mg) in accordance with normal pharmacological practice. Patients in the midazolam and fentanyl groups were given intravenous midazolam (0.5–4 mg) plus intravenous fentanyl (25–125 mcg) with fentanyl similarly dosed based on age, gender, and body mass. Patients from the midazolam group that required additional sedation were given a second dose of midazolam. If adequate sedation could not be achieved with midazolam alone, they were allowed to crossover and receive fentanyl. In all patients, local anesthetic (1% xylocaine) was administered at the access site after administration of sedation. Oral diazepam (5–10 mg) and diphenhydramine (25 mg) were given 30 minutes before commencement of the procedure unless patients were allergic to these medications. After the procedure, patients who underwent femoral arterial access were positioned supine and flat for at least 2 hours (longer if no closure device was deployed). Patients who underwent catheterization via the right radial artery had a radial compression bracelet placed and were allowed to sit up after returning to the recovery room. Patients were administered a pain survey by a research assistant to complete at the time of discharge .Informed consent was obtained, and patients were randomly assigned to two groups: midazolam monotherapy (Participants were asked if they experienced any pain during their procedure (yes/no) and, if yes, asked to rate their overall pain level for the periprocedural period using a 10-point Likert scale that ranged from 1  to 10 (worst pain imaginable). Patients that had undergone prior LHC were asked to compare their level of pain to prior LHC .d = 0.5, associated with the difference in treatment modalities. Using the aforementioned effect size, a two-sided hypothesis, an alpha value of 0.05, a beta value of 0.20, and an equal allocation ratio to treatment arms (1 : 1), it was found that n = 128 participants would be needed in the study to achieve adequate statistical power to detect a difference if it actually existed in the population. The sample size calculation was performed using G∗Power Version 3.1.We hypothesized a medium effect size, t-tests were used to compare the groups on continuous variables. Means and standard deviations were reported and interpreted for the t-test findings. Statistical significance was assumed at an alpha value of 0.05, and all analyses were performed using SPSS Version 26 .Statistical analysis was performed using chi-square analyses to compare the midazolam and midazolam plus fentanyl groups on categorical variables. Frequency and percentage statistics were used to describe the statistical findings of the chi-square statistics. Independent-samples n = 107) were classified as overweight or obese according to their body mass index (≥25 kg/m2). The baseline demographics of the study population are listed in A total of 129 patients were enrolled and completed the patient pain questionnaire . Particip=0.78). The average pain scores were identical between the two treatment groups as indicated in p=0.95). Nearly half of the patients had undergone prior LHC . Twenty-seven patients reported similar pain compared to their last LHC, 30 reported less pain, and 6 patients reported more pain, which did not statistically differ between the two groups. Of the 69 patients in the midazolam monotherapy group, only 16% (n = 11) crossed over and received fentanyl.In general, patients reported a low level of discomfort during the procedure. The percentage of patients who experienced any pain was similar between the midazolam and midazolam plus fentanyl groups . Patients who reported pain during their procedure had longer average procedure times compared to patients who did not report any pain . The rates of pain did not statistically differ based on artery accessed . Of the patients who did report pain, pain scores did not differ based on arterial access site .There were 6 patients in each treatment group who reported a history of chronic pain. Patients with a history of chronic pain who received only midazolam reported higher average pain scores than patients with chronic pain who received both midazolam and fentanyl , patients with chronic pain reported lower average pain scores when they received both fentanyl and midazolam for sedation . Longer cases may benefit from sedation with midazolam and fentanyl as well. Patients who reported pain had an average procedure length of 52.51 minutes (SD = 22.87 minutes) compared to 35.84 minutes (SD 43.91) in patients who did not report pain (p=0.006). Musculoskeletal pain, particularly lumbar pain, is the most common site of pain reported during left heart catheterization [p=0.63).There are clinical scenarios where an initial sedation strategy with midazolam and fentanyl may still be utilized. Although we enrolled few patients with a history of chronic pain .The primary limitations of our study include smaller sample size, single center, and single-blinded randomization. Other limitations involving the study design include patient reporting on a questionnaire, crossover allowance from midazolam monotherapy to midazolam and fentanyl, and more females in the midazolam plus fentanyl group. These limitations are minimized by the outcomes observed. Assessment of pain relied upon patient reporting postprocedure, which is subjective, and each patient may have a different pain tolerance. Eventhough our study design allowed for crossover, patients in the midazolam group rarely crossed over to receive fentanyl for sedation (17%, Midazolam monotherapy produces similar pain perception compared to a combination of midazolam and fentanyl during sedation during cardiac catheterization. The combination of midazolam and fentanyl has historically been the standard regimen for sedation in the catheterization lab. However, it may be important to consider midazolam monotherapy as an alternative. We believe a larger, randomized multicenter study is needed to further validate our findings. This is an important issue for multiple reasons including fentanyl's documented inhibition of absorption and efficacy of P2Y12 agents, potential cost savings of reducing fentanyl use, and reducing potential for opioid addiction. This study suggests that midazolam monotherapy is a reasonable option for sedation for cardiac catheterization.


This stepped wedge, cluster randomized trial evaluated the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services. Can guideline implementation strategies improve pain outcomes in adult outpatients with cancer-related pain?In this cluster-randomized trial of 544 patients, a suite of implementation strategies comprising audit and feedback, clinician-spaced education, and a patient self-management resource was evaluated. There was no statistical difference in pain-related outcomes, and fidelity, which was measured by uptake of the 3 implementation strategies, was lower than expected.These findings suggest that cancer pain screening and subsequent management will need to be highly valued, supported by adequate resources embedded within the clinical workflow, and supported by electronic data systems to be successful. An evidence-practice gap exists for cancer pain management, and cancer pain remains prevalent and disabling.To evaluate the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services.A pragmatic, stepped wedge, cluster-randomized, nonblinded, clinical trial was conducted between 2014 and 2019. The clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics. Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS). Data were collected between August 2015 and May 2019. Data were analyzed July to October 2019 and reanalyzed November to December 2021.Guideline implementation strategies at the cluster, health professional, and patient levels introduced with the support of a clinical champion.The primary measure of effect was the percentage of participants initially screened as having moderate to severe worst pain (NRS ≥ 5) who experienced a clinically important improvement of 30% or more 1 week later. Secondary outcomes included mean average pain, patient empowerment, fidelity to the intervention, and quality of life and were measured in all participants with a pain score of 2 or more 10 at weeks 1, 2, and 4.P = .51). No significant differences were found in secondary outcomes between phases. Fidelity to the intervention was low.Of 8099 patients screened at 6 clusters, 1564 were eligible, and 359 were recruited during the control phase  and 329 during the intervention phase , with no significant differences between phases on baseline measures. The mean (SD) baseline worst pain scores were 5.0 (2.6) and 4.9 (2.6) for control and intervention phases, respectively. The mean (SD) baseline average pain scores were 3.5 (2.1) for both groups. For the primary outcome, the proportions of participants with a 30% or greater reduction in a pain score of 5 or more of 10 at baseline were similar in the control and intervention phases (31 of 280 participants [11.9%] vs 30 of 264 participants [11.8%]; OR, 1.12; 95% CI, 0.79-1.60; A suite of implementation strategies was insufficient to improve pain-related outcomes for outpatients with cancer-related pain. Further evaluation is needed to determine the required clinical resources needed to enable wide-scale uptake of the fundamental elements of cancer pain care. Ongoing quality improvement activities should be supported to improve sustainability. Third, we evaluated the implementation strategies’ capacity to assess the cost-effectiveness of the 3 guideline implementation strategies based on incremental cost per additional responder on the primary outcome. Fourth, we assessed their fidelity to the intervention. The current article reports results relating to the primary aim and the first and third of the secondary aims.This study’s primary aim was to measure if the intervention resulted in a 30% improvement in pain score in adults attending oncology or palliative care outpatient clinics with a pain Numeric Rating Scale (NRS) score of 5 or more. Four secondary aims were included to evaluate the capacity of 3 guideline implementation strategies compared with standard care in people screened for cancer pain alone. First, we evaluated the implementation strategies’ ability to reduce the mean worst pain and mean average pain severity throughout the past 24 hours across patients screened as having clinically relevant  or moderate to severe  worst pain from the time of screening to 1, 2, and 4 weeks later by an SD of 0.5.CONSORT Extension) reporting guideline.24 Ethical approval was granted by the human research ethics committee of the Southwestern Sydney Local Health District. Following commencement of the trial, an approved amendment allowed for patients to provide verbal consent rather than written consent to ensure timely collection of data at week 1. The methods are reported in Luckett et al25 and summarized below. The trial protocol can be found in This stepped-wedge, cluster-randomized trial was reported according to the Consolidated Standards of Reporting Trials Extension  who did not opt out. Caregivers were eligible if they were identified by a patient, provided consent, and had sufficient English to give informed consent and complete the measures. Staff were eligible if they were employed permanently, either full- or part-time, and provided care or administrative support to patients at a participating cancer center.Our study design enabled the intervention to target practice change at the center level without risking contamination between phases and control for practice variation between centers. Centers were randomized to transition one at a time. Each patient was recruited to participate in either the control or intervention phase, but not both, thus, samples differed between phases and consent was obtained. The time between each step was not predetermined by dates but rather by the readiness of centers to commence and the speed they recruited to the target sample size. A sustainability phase was also included in the design wherein medical records of patients screened as having severe pain (≥7 NRS) were audited at 3-month intervals from the end of the intervention phase to the end of the study period to assess whether adherence to guidelines for pain screening, assessment, and management were continued.The order in which each center moved from control to intervention phase was randomly allocated by a computer algorithm performed by the study statistician. Allocation of clusters could not be concealed from clinicians and managers. Blinding for center staff and the project team collecting data was not possible. However, information for patients provided only general information about the aims of the study, not the specifics of the design and intervention. Patients were allocated based on whether the center they attended was in the control or intervention phase at the time they were first screened as having worst pain rated 2 or more on the NRS.A paper-based screening system was implemented at each center whereby all patients were requested to complete an NRS for worst pain and average pain during the past 24 hours on each visit. Pain screening was administered to patients in the waiting room either by administrative personnel or nursing staff, depending on the center. Each center provided usual care, as per local practice. No attempt was made to encourage or discourage pain screening data being used to inform patient consultations.26 included: (1) audit of adherence to 6 key guideline recommendations and feedback delivered in 1 to 2 cycles; (2) health professional education using email-administered spaced education via the Qstream platform;27 and (3) an education booklet and a patient self-management resource. These strategies have a positive impact when implementing guidelines either in cancer pain or other clinical contexts but have never been tested in combination.During the training phase, center clinicians were given an overview of the guidelines and implementation resources by a local clinical champion with support from the project team. A system was established at each center to enable screening results to be communicated to the physician to inform the consultation. Guideline implementation strategies developed using a conceptual framework (Michie Behavior Change Wheel)Patient-reported outcome measures were obtained by researchers contacting participants by phone who scored 2 or more on either NRS at the time of screening. If the participant could not be reached after 3 attempts on 3 consecutive days, their data were categorized as missing for that time point.28 Pain rated as 5 on the NRS was selected as an established threshold for moderate pain.29 Secondary outcomes were collected via telephone at weeks 1, 2, and 4 after screening and consisted of worst pain and average pain NRS, patient empowerment heiQ,21 carer experience with the CES23, and patient QOL using the EORTC QLQ-C15-PAL.22 Data collection deviated from the protocol by collecting only the following domains of the heiQ after the whole measure was found too burdensome for patients: social integration and support, health service navigation, constructive attitudes and approaches, and skill and technique acquisition.The primary study outcome was the percentage of patients at the cluster level screened with a score of 5 or more out of 10 on a worst pain NRS with a pain reduction of 30% from the initial NRS at week 1. Thirty percent was selected based on the US Food and Drug Administration recommendations, which indicate that measurement of minimal clinically important difference should take account of the baseline score.14 The number of audit and feedback rounds was counted.Fidelity was assessed for each part of the intervention. The number of patients receiving written pain education materials was assessed by asking the patient over the telephone at week 1 if they had received them. This was implemented after the first site completed and hence, we have data for 5 sites only. The clinicians’ completion of the online spaced education module was measured via the administering platform of QStream platform.30 outcome data were generated to mimic the pain scores we expected to see in the presenting population. Data were analyzed using Stata version 17 BE (StataCorp). Sample size required was 82 at 6 sites totaling 492. The sample size calculation was based on the statistical approach for analyses being the Generalized Linear Mixed Model with a 2-tailed test. Pearson χ2 tests or the Student t test were used to compare baseline patients’ characteristics between control and intervention phases. To cater for the cluster effect in the primary outcome measure, the generalized linear mixed model with a binary outcome was applied to examine the differences in proportions of pain score reduction by 30% between phases with adjustment for possible confounding variables, such as age, gender, cancer type, Qstream, information pack, audit cycles, and the time spent in each phase. A similar analytical approach was adopted to analyze all secondary outcome measures with adaptation for continuous variables. For testing of the hypothesis, a 2-tailed error rate of 5% was used.We used a carefully designed computer simulation, allowing for 20% dropout by both centers and patients, to estimate statistical power. Drawing on data from 1612 consecutive patients,P < .05 was used for all tests. Data were collected between August 2015 and May 2019. Data were analyzed July 2019 to October 2019 and data were reanalyzed in November and December 2021.A statistically significant level of This study included 8 centers, 2 regional and 6 metropolitan, across 3 Australian states between August 2015 and May 2019. Two regional centers withdrew after completing the control phase because of a lack of resources or slow patient recruitment. The remaining results focus on the remaining 6 centers .A total of 8099 patients were screened from whom 1564 were eligible for either primary or secondary outcome measures. Of these, 754 patients gave consent to participate in the study. These 6 centers were randomized to receive the intervention in order resulting in 359 patients in the control phase and 329 in the intervention phase, with 544 contributing to primary outcome measurement. In terms of the missing values in the follow-up period , the patterns of missing were not associated with the main demographic variables suggesting missing completely at random.Baseline characteristics for samples of patients contributing data to primary and secondary outcomes are summarized in The duration of phases varied between centers, with the control phases lasting between 84 and 255 days and the intervention phases between 120 and 338 days. Initially, the training phase was planned to last 3 weeks. However, this was not possible at 2 centers because of time constraints, with the result that they transitioned from control to intervention phases within a few days only. The sustainability phase was also abandoned because of lack of resources at centers to continue the intervention after resourcing from the project team was removed. The stepped-wedge timeline is shown in For the primary outcome, namely a reduction in the pain score by 30% among those with a score of 5 or more on the NRS on worst pain at week 1, there was no significant difference between the control and intervention phases. The proportions were similar with 31 of 280 participants (11.9%) in the control phase and 30 of 264 participants (11.8%) in the intervention. After adjusting for the potential confounding variables, the results indicated no significant increase in the odds of the outcome . Results on the secondary outcome measures are also summarized in Changes in pain scores within each phase are reported in Fidelity to the intervention was lower than anticipated. Two sites had 2 audit cycles and the other sites had 1. Completion rates of health professional training varied between sites from 12% to 74%. The proportion of patients receiving written information (5 sites) was 30% (20%-44%) vs 22% (2%-30%) in the control arm.26 evidence-based implementation strategies, and services with clinical champions.31 Participants in both phases reported improved mean and worst pain scores over time. However, the lack of a comparison group where no screening was offered means we cannot conclude whether this improvement was because of screening, usual pain management, or a Hawthorne effect.32In this adequately powered, stepped wedge, cluster randomized trial, guideline implementation strategies at the level of the clinical service, health professional, and patient did not deliver a 30% or greater improvement in patients’ pain compared with usual care. This finding was despite the combined use of a conceptual framework,26 The use of an explicit implementation framework, such as PARIHS , would likely have helped us to better understand and act upon the implementation issues arising from this evaluation trial as it was conducted.33 Centers participating had high baseline knowledge of pain guidelines and high proportions of complex patients with refractory pain. Barriers to pain management previously identified, including participation in pain management intervention being seen as a lower priority and related trials as less important a contribution to the knowledge base than those concerned with curative treatment, may have been contributing factors.19 The team is currently analyzing qualitative data collected during the trial to better understand the challenges to fidelity and how this might be improved in the future.There are several potential explanations for the lack of effect difference between groups. Interventions added to usual care are inadequate without dedicated resourcing and focus. The fidelity to the intervention may have been insufficient in terms of the number of rounds of audit and feedback and proportions of staff and patients who completed the spaced education module. The implementation of these strategies as a multicomponent intervention may have required a more intensive approach and more effective engagement with the cancer service management than was achieved. We had used a behavior change framework to design the interventions.34 Optimistically, it may be that improvements in the screening condition resulted from clinicians using the data during consultations without the need for prompting introduced during the Intervention phase. However, previous randomized clinical trials of screening interventions vs no screening in outpatient services have rarely demonstrated improvements in pain scores, especially in palliative care.35 Also, the current study used a paper-based screening system, which has largely been replaced in more recent literature by electronic systems due to their better potential for integrating with electronic health records and therefore influencing processes of care.36 We used paper-based screening because technical problems with electronic screening encountered when piloting the intervention at a single center suggested it would not be feasible to implement across multiple centers during the study period.9 Additionally, patient recall over weeks may vary.37 The strategies targeted the service but not the health system policies and procedures for the collection of PROMs, and this system-level change is needed for embedding screening into routine care.Our finding that pain improved during both phases mirrors the findings of at least one other study that compared screening alone with screening plus a pain treatment protocol.38 the incidental observation that these were not routinely collected in cancer centers requires further attention. The PROM collection was seen as research rather than a clinical practice tool and changing this mindset among clinicians is an important direction for person-centered care.39Given evidence that collecting and acting on (PROMs) improve outcomes,40 A major barrier to optimal patient education was the lack of nurses in ambulatory care. Adequate staffing with nurses in ambulatory care would provide rapid, focused assessment of patients, develop long-term nurse, patient, and family relationships, and deliver patient education.41Patient education is effective in pain management and should be embedded in workflow for cancer patient care.42This study had limitations. Methodological limitations included the fact that there was poor participation for secondary outcomes at week 1 because many potential participants did not receive the information and consent documents by mail in the requisite time frame. The fact that center staff and the research team could not be blinded may have biased the patient selection and outcome data collection. Response bias was less likely because patients were only minimally aware of the study aims and design. There was also potential for selection bias because of patients who chose not to complete screening or found rating pain difficult with numeric rather than categorical scales. It may be that phone collection of PROMs resulted in different results than in-person collection; however, studies in other populations have found comparable results.In this study, pain management guideline implementation strategies did not significantly improve pain-related outcomes for outpatients with advanced cancer compared with usual care. This likely reflects limited intervention uptake by centers, perhaps because of a lack of additional dedicated resources. Oncology ambulatory care services require adequate resources to provide routine pain screening, patient and staff education, and quality improvement cycles.


Chronic pain is frequently reported after total hip and knee arthroplasties (THA/TKA) in osteoarthritis (OA) patients. We investigated if severity of acute postoperative pain following THA/TKA in OA patients was associated with pain during the first postoperative year. From an observational study, OA patients scheduled for primary THA/TKA (June 2012–December 2017) were included from two hospitals in the Netherlands. Acute postoperative pain scores were collected within 72 h postoperatively and categorized as no/mild (NRS ≤ 4) or moderate/severe (NRS > 4). Pain was assessed preoperatively, 3, 6 and 12 months postoperatively using the HOOS/KOOS subscale pain. With Multilevel Mixed-effects-analyses, we estimated associations between acute and chronic pain until one year postoperative, adjusted for confounders and including an interaction term (Time*Acute pain). 193 THA and 196 TKA patients were included, 29% of THA and 51% of TKA patients reported moderate/severe pain acutely after surgery. In the THA group, the difference in pain at 3 months between the no/mild and moderate/severe groups, was approximately six points, in favor of the no/mild group (95% CI [−12.4 to 0.9]) this difference became smaller over time. In the TKA group we found similar differences, with approximately four points (95% CI [−9.6 to 1.3]) difference between the no/mild and moderate/severe group at 6 months, this difference attenuated at 12 months. No association between severity of acute postoperative pain and pain during the first postoperative year was found. These findings suggest that measures to limit acute postoperative pain will likely not impact development of chronic pain.The online version contains supplementary material available at 10.1007/s00296-022-05094-4. Approximately 20% of the general adult population suffers from OA of the knee, hip or hand, with increasing numbers due to age and obesity, resulting in increasing numbers of patients in pain due to OA . Pain isApart from the fact that patients often suffer from pain prior to surgery, chronic pain after total hip and knee arthroplasty (THA/TKA) is an often reported unfavorable outcome , 7, withIn surgical patients, (intensity of) acute postoperative pain has been postulated as a risk factor for chronic postoperative pain, although results are somewhat heterogeneous. . NeverthConsequently, we performed a longitudinal, multi-center study to investigate if severity of acute postoperative pain, following THA or TKA in OA patients, is associated with chronic pain during the first postoperative year.This study was part of the ongoing cohort Longitudinal Leiden Orthopaedics and Outcomes of Osteoarthritis Study (LOAS)  . In shorAcute pain scores were assessed by a nurse and reported in the medical file, every three hours within 72 h after surgery , using the Numeric Rating Scale (NRS) at rest. This was part of standard care in both hospitals. The NRS provides a number between 0 and 10, with 0 meaning no pain and 10 meaning the worst pain possible . An averPatients for THA received spinal, combined spinal-epidural or general anesthesia during surgery. Postoperative pain relief was achieved by a combination of paracetamol, NSAID and morphine subcutaneously. Patients were discharged with oral oxycodone. TKA was performed under spinal, combined spinal-epidural or general with epidural anesthesia. Postoperatively, patients received a combination of paracetamol, NSAID and a patient controlled epidural anesthesia (PCEA) pump or an intravenous patient controlled anesthesia (PCA) pump with either morphine or fentanyl in case of spinal anesthesia. After epidural anesthesia was terminated, morphine was subcutaneously administered. Patients were discharged with oral oxycodone. Using questionnaires, patients were asked to report the use of acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) in the past six months before surgery, because of hip or knee complaints  daily, few days per week, few days per month), and indicate the persistence of hip or knee joint symptoms . Additionally, duration of surgery (minutes) and hospitalization (days) were collected from the medical records as possible proxies for complications during and after surgery .Prior to surgery, and at 3 (if THA), 6, and 12 months after surgery patients received questionnaires to obtain pain scores using validated Dutch versions of the Hip disability of Knee injury and Outcomes of Osteoarthritis Score (HOOS/KOOS) . These q2)), type of anesthesia , living arrangement ) and working status . To indicate the mental health status of the patient, the subscale Mental Component Summary of the Short-Form-12 (MCS-12)  was used [The following sociodemographic characteristics were collected: age, sex, Body Mass Index . Of these patients, 23 had no follow-up data, and 74 had no acute pain scores available, resulting in 168 LUMC patients  to be included  and Chi-Square tests (for proportions). Baseline characteristics of included and excluded patients were compared to assess for selection bias. Although not statistically tested to avoid multiple testing, no clinical important differences were found between included and excluded patients (Supplementary Table 1).All analyses were performed while stratified by joint (hip or knee). Patients were grouped according to their acute postoperative score . To compare the characteristics of patients with no/mild and moderate/severe acute postoperative pain, we performed Mann–Whitney We used multilevel mixed-effects-analyses to assess whether severity of acute postoperative pain was associated with pain during the first postoperative year, because it takes the between-patient correlation into account. The models included a group variable based on acute postoperative pain  and a time variable . The models included subject-specific intercepts and a random effect to account for the correlation between repeated measures over time in the same patient, while correcting for originating hospital as patient population could vary between both hospitals. By including an interaction term between acute postoperative pain and timing of postoperative pain measurement , 6 and 12 months postoperatively), we were able to assess whether acute postoperative pain affected postoperative pain during the first year after surgery. Further, we corrected for several confounders: age, sex, BMI, preoperative HOOS/KOOS pain score, preoperative MCS-12 score, surgery duration, hospitalization duration/length and type of anesthesia , 32. MisA total of 193 THA ) and 196 TKA patients ) were included in the present study  was added to the models. In the THA group, the difference between the no/mild and moderate/severe groups, was approximately 6 points  at 3 months in favor of the no/mild group, and the difference became smaller over time. In the TKA group we found similar differences, with approximately 4 points  difference between the no/mild and moderate/severe group at 6 months. The differences attenuated at 12 months. None of the coefficients showed clinically or statistically significant differences between no/mild and moderate/severe acute postoperative pain and postoperative pain during the first postoperative year  yielded similar results.In this study we investigated if severity of acute postoperative pain, following THA or TKA in OA patients, was associated with pain during the first postoperative year. Almost one-third of THA, and more than half of TKA patients reported moderate/severe acute postoperative pain. Nevertheless, our findings indicated that severity of acute postoperative pain after THA or TKA was not associated with postoperative pain during the first postoperative year in this population.Our findings are consistent with previous studies that were unable to show an association between acute and chronic postoperative pain in THA and TKA patients , 20, 21.While our study is in concordance with some studies that assessed the effect of acute pain in OA patients after THA and TKA, our findings are inconsistent with other surgical fields that consider intensity of acute postoperative pain as a risk factor for the development of chronic pain . A possiIt is known that chronic pain is associated with changes in the peripheral and central nervous system in response to acute injury, such as surgery or trauma. This could result in hypersensitivity of the nervous system and if persistent, lead to central sensitization . SeveralAs chronic pain could be the result of either chronic preoperative pain or (sub)acute postoperative pain, it is difficult to differentiate whether chronic postoperative pain is the result of (sub)acute postoperative pain from the surgery or ongoing preoperative pain. Future cohort studies including more extensive measurements for study purposes on preoperative and (sub)acute postoperative pain, preoperative data on endogenous pain modulation and quantitative sensory testing including central sensitization , should Pain experience in OA has a multidimensional nature, which causes the underlying etiology of OA-pain also to be multifactorial. Several modifiable risk factors have been reported that could reduce pain before surgery: losing weight, healthier dietary choices, levels of physical activity, use of assistive devices (i.e. insoles), decrease the number of medical comorbidities, pain catastrophizing and coping, and psychological factors, such as anxiety, distress and depression might also affect postoperative pain , 41, 42.This study has several strengths and limitations: We imputed missing values in confounders, therefore refraining from exclusion of patients with missing values. After comparing the current population with the excluded patients we found no clinically relevant differences (Supplementary Table 1). Therefore we expect that no selection bias has occurred. A possible limitation could be the method of acute postoperative pain collection from medical records, which was part of standard care. Hence, acute pain was not collected with the intention to use for study purposes, and were therefore not regularly recorded by the same nurse, which could have affected the consistency. Furthermore, there is no consensus on cut-off points for NRS pain, which might affect generalizability , 43–46. We found that a substantial group of THA and TKA patients reported moderate/severe acute postoperative pain, but no association between severity of acute postoperative pain and chronic pain during the first postoperative year was found. Although it is important to limit the presence of acute postoperative pain as much as possible, acute postoperative pain does not seem to be associated with postoperative pain. Therefore, efforts to reduce the presence of chronic pain should be focused elsewhere, such as reduction of preoperative pain, or psychological well-being of the patient.Supplementary file1 (DOCX 16 KB)Supplementary file2 (DOCX 13 KB)Below is the link to the electronic supplementary material.


It is hypothesized that if it is confirmed that the pain caused by the injection needle coincides with the lower leg radiating pain(LLRP) that the patient mainly complains of, then the contrast agents may be used less. This study aims to understand if the identification of lancinating identical pain in the procedure could replace the use of contrast agents that causes additional pain provocation using control arm of randomized clinical trial.This retrospective study included 165 patients who met exclusion criteria from among patients who underwent Selective nerve root block for the treatment of LLRP. With the identical and lancinating pain confirmed in the same site of the patient, consistent with that of the original symptom, the subjects were divided into 2 groups: 1 without contrast injection  and the other with contrast injection . The degree of LLRP in the 2 groups was evaluated using visual analog scale (VAS) before injection, 2, 6, and 12 weeks after injection. Functional outcomes were measured using Owestry Disability Index and Rolland-Morris Disability Questionnair, whereas quality of life was measured using Physical component score and Mental component score of Short Form 36 (SF-36) before injection and 3 months after injection.P > .05). At 12 weeks after injection, there was a statistically significant difference, but they were below Minimum Clinical Important Difference, bearing little clinical implications. There was no statistically significant difference between the 2 groups in Owestry Disability Index, Rolland-Morris Disability Questionnair, SF-36 Physical component score, and SF-36 Mental component score at every interval .There was no statistically significant difference in the LLRP severity in both groups at all times and no statistical difference in the degree of VAS improvement relative to the before-injection VAS value between the 2 groups at 2 and 6 weeks after injection (all Instead of contrast agent injections that have been used for accurate nerve root identification during Selective Nerve Root Block, the method of merely checking if the needle-induced pain under fluoroscopic imaging is consistent with the LLRP that the patient predominantly experiences shows the same effect in the patient's pain control and functional outcome. These pains are radiated to the thighs, calves, ankle joints and soles, and these lancinating feelings of stabbing, burning, electrifying, dull, or worms crawling are very sensitive symptoms occurring in nerve root irritated symptoms. To alleviate this radiating pain, manual therapy, physical therapy, massage, and various drug treatments have been presented, and among them, anti-inflammatory agents, muscle relaxants, and calcium channel blockers  have been under investigation in a number of studies. Recently, epidural injection therapy and Selective Nerve Root Block (SNRB) are commonly practiced as minimally invasive treatments. SNRB is a method for alleviating pain by injecting glucocorticoids and local anesthetics into the compressed nerve roots that cause radiating pain. Disagreement persists over the ultimate therapeutic effect of SNRB but the dominating opinion among researchers is that it is effective in the short term.–5 Although less common, there is a possibility of anaphylactic shock due to contrast agents. It is independent of the method of administration and dosage, difficult to predict if there is no history of anaphylactic shock after the use of contrast agents, and sometimes very fatal to the patient. In addition, while injecting contrast agents may give patients additional LLRP, additional radiation exposure, or delay in procedure time, care should be taken when they are used in patients with renal disease. Therefore, it is hypothesized that if it is confirmed that the pain caused by the injection needle coincides with the radiating pain that the patient mainly complains of, then the contrast agents that cause additional side effects may be used less.However, various complications may occur during this SNRB. Among these are adverse reactions to gluococorticoid and radiation exposure, as well as various problems caused by the contrast agents used to identify the injection site.The purpose of this study was to understand if the identification of lancinating identical pain in the procedure could replace the use of contrast agents by dividing the patients into 2 groups, 1 with contrast agent injection to ensure that the needle tip was located in the nerve root to be blocked and the other without contrast agent injection but with lancinating identical pain imposed in the same site and compare the 2 groups in terms of improvement in pain and functional results.22.1This trial was approved by the institutional review board  of our institution and conducted in accordance with the declaration of Helsinki. The subject pool was a total of 655 patients with radiating pain of 5 or higher on the visual analog scale (VAS) who underwent SNRB for therapeutic purposes between January 2015 and November 2019. Lesions consistent with symptoms in those patients were identified using magnetic resonance imaging and 165 patients who met all exclusion criteria were analyzed. Patients who were pregnant, with secondary interests , with serious comorbidities, who could not be followed up for more than 3 months after injection for personal reasons, with contraindications to the drug, under an intervention study during the study period, and with cancer pain due to primary or metastatic cancer in the spine were excluded  followed by injection of medication via a 23-gauge spinal needle under fluoroscopic guidance. A spinal needle was advanced at a safe triangle in the spinal root site. Patients were randomly divided into 2 groups. Random allocation of treatment regiments using permuted block randomization method was performed by another doctor who was not involved in treatment or evaluation. In 1 group (Non-Dye group: ND group), after identical and lancinating pain was confirmed, and if the location of the pain matched the site of the original symptom, medication was administered without a contrast agent, and in the other group (Dye group: D group), only twinge was confirmed as the injection needle was advanced. In such a case, contrast agent  was administered to confirm the injection site and location of the affected spinal nerve root  to 10 (the worst pain imaginable). The degree of pain was assessed at 2, 6, and 12 weeks after injection. The spine-related functional outcome was assessed using the Oswestry Disability Index (ODI) and Roland–Morris Disability Questionnaire (RMDQ) before injection and 3 months after injection, whereas quality of life was measured using SF-36, which was divided into mental component score (MCS) and physical component score (PCS), before injection and 3 months after injection.2.4P value of ≤.05 was considered statistically significant.One-way analysis of variance, correlation analysis, and repeated-measures single-factor analysis methods were used. Fisher exact test for the distribution of gender and injection nerve roots were used. Data are presented as mean ± standard deviation. The IBM Statistical Package for the Social Sciences version 19.0 for Windows  was used for all statistical analyses. A 33.1P = .309). The average age was 68.46 ± 11.21 years old in total, 69.70 ± 9.61 in ND group, and 67.81 ± 11.92 in D group, which was not statistically significant (P = .305). There were 9 patients in the ND group and 13 patients in the D group who had decompression surgery following no improvement after SNRB. Nerve root sites included 7 L3 roots, 24 L4 roots, and 26 L5 roots in the ND group and 15 L3 roots, 51 L4 roots, 40 L5 roots, and 2 S1 roots in D group  in total, 57  were in ND group, and 108  in D group. There was no statistical significance for the sex ratio of each group (3.2P = .515), 2 weeks after injection (P = .389), 6 weeks after injection (P = .378), and 12 weeks after injection (P = .116).The VAS before injection was 7.35 ± 1.73 in the ND group and was 7.17 ± 1.70 in the D group. The VAS at 2 weeks after injection was 3.07 ± 2.34 in the ND group and 3.40 ± 2.29 in the D group. The VAS at 6 weeks after injection was 3.47 ± 2.60 in the ND group and 3.83 ± 2.40 in the D group. The VAS at 12 weeks after injection was 3.19 ± 2.99 in the ND group and 3.81 ± 2.27 in the D group. There was no statistically significant difference in VAS between ND group and D group before injection . At 12 weeks after injection, the group difference was statistically significant (4.37 ± 2.81 in Group ND and 3.48 ± 2.43 in Group D) (P = .037), but these scores were not above 5 in Minimum Clinical Important Difference of Parker et al, bearing no clinical implications . There was no statistically significant difference in the improvement rate of ODI, RMDQ, SF-36 PCS, and SF-36 MCS at 3 months after injection between the 2 groups, compared with that before injection (P > .05) (Table Before injection, ODI was 21.82 ± 8.92, RMDQ 11.30 ± 6.19, SF-36 PCS 27.76 ± 14.38, and SF-36 MCS 44.42 ± 20.91 in Group ND, whereas ODI was 23.24 ± 9.16, RMDQ 11.40 ± 6.81, SF-36 PCS 26.33 ± 17.59, and SF-36 MCS 39.32 ± 20.15 in Group D. At 3 months after injection, ODI was 16.00 ± 9.21, RMDQ 8.54 ± 6.18, SF-36 PCS 41.50 ± 23.73, and SF-36 MCS 51.41 ± 22.40 in ND group, and ODI was 17.93 ± 10.20, RMDQ 9.07 ± 9.24, SF-36 PCS 41.78 ± 22.41, and SF-36 MCS 50.69 ± 20.85 in D group. There was no statistically significant difference in ODI, RMDQ, SF-36 PCS, and SF-36 MCS between ND group and D group at both the before injection and 12 weeks after injection (all 4 In this procedure a needle tip is inserted under fluoroscopic guidance into the root sleeve of the nerve root and then, the exact site is confirmed using radio-opaque dyes and with induced pain in the patient, and injection is made to alleviate the radiating pain. Since then, various options for nerve root identification have been used, including computed tomography, ultrasound imaging, and electrostimulation,–12 but until now, the method by Macnab et al has been used most widely. Each radiological finding, however, included the use of a contrast agent, even though in a small amount, for nerve root identification. Pfirrmann et al and Irwin et al classified the anatomical position of the contrast agent into intraneural, extraneural, and perineural to judge the tip of the needle and analyzed the effect of the injection. After confirming the nerve root by inducing LLRP due to the progression of the needle tip under the initial radiographic image guidance, pulling the needle slightly back and then injecting 0.5 mL of contrast media to confirm the correct level, they injected adrenocortical hormone and a local anesthetic. Although the needle tip is withdrawn slightly after pain provocation, the patient must experience additional pain provocation when contrast media are injected. The correct level is confirmed 3 times: fluoroscopic imaging during SNRB, pain provocation in the lower extremity by the needle tip as the needle progresses, and radiological imaging using contrast media. Given that the injection site is determined using fluoroscopic imaging, pain provocation by a needle tip as the needle progresses, and determining whether this pain is identical to the pain in the lesion consistent with the area of the patient's lower extremity pain, this study aimed to investigate whether circumventing the injection site identification by additional contrast media was possible.SNRB began being performed in 1971 by Macnab et al reported that their analgesic outcome was independent of the use of contrast agents. However, the authors confirmed that the location of the injection needle was confirmed by the operator's reassurance and the fact that it was not the intravascular needle placement and did not describe the method of reassurance accurately. In addition, it was suggested that the reason for no difference in their results was due to local diffusion or systemic effect of the injectant, but a clear causal relationship was not presented. Mallinson et al and Pfirrmann et al claim that the pain provocation caused by the contrast agent indicates that the contrast agent means intraepineural injection and has little to do with the patient's functional outcome. After all, they argued that not only the contrast agent used in SNRB but also the pain provocation caused by the contrast agent itself is independent of the patient's functional outcome and the contrast agent is used only for re-identification of the nerve roots that cause the radiating pain in the patient's lower extremity.In a study involving 283 patients with nerve root block of the cervical, thoracic, and lumbar spine, Mallinson et alContrast agents used in SNRB can lead to fatal adverse effects due to anaphylactic shocks in some patients and may cause acute renal failure in vascular disease patients, diabetics, and elderly people with renal disease. There may also be a risk of unpleasant sensation to the patient due to lower extremity pain caused by injection of contrast medium once again after radiating pain is induced in the extremity pain through the injection needle, and direct intraepineural injection of the contrast agent may lead to mechanical impairment. In addition, extended procedure time, additional radiation exposure, and added cost burden due to the insertion of the contrast agent may also be a problem.The limitations of this study are as follows: First, there was a lack of data on side effect of corticosteroid which occurred actually during this study. Second, only the results of improvement of VAS, functional outcome and quality of life were obtained. Third, a relatively short follow-up period of 3 months is one of the limitations. Forth, the number of patients in each group was too small to analyze the mechanism and related factors, although this was a randomized method.5During SNRB, fluoroscopic imaging, pain provocation caused by the tip of the needle, and whether the radiating pain induced in the lower extremity matches the patient's chief complaint are sufficient to identify the nerve roots correctly, which can lead to reduced use of contrast agents. It reduces rare fatal hypersensitivity shocks associated with the dye and acute renal failure in high-risk patients, delayed procedure time following dye injection, additional radiation exposure, and unpleasant sensation to the patient by contrast injection, as well as mechanical impairment by intraepineural injection of additional contrast medium.Conceptualization: Sangbong Ko.Data curation: Sangbong Ko, Junho Nam.Formal analysis: Sangbong Ko.Funding acquisition: Sangbong Ko.Investigation: Sangbong Ko.Methodology: Sangbong Ko.Project administration: Sangbong Ko.Resources: Sangbong Ko.Software: Sangbong Ko, Junho Nam.Supervision: Sangbong Ko.Validation: Sangbong Ko.Visualization: Sangbong Ko.Writing – original draft: Sangbong Ko.Writing – review & editing: Sangbong Ko, Junho Nam, Jaejun Lee.