To compare the effect of premedication with 2 different doses of oral paracetamol to prevent pain at propofol intravenous injection.We conducted a double-blind randomized controlled trial in which patients scheduled for induction of general anesthesia with intravenous propofol received either a placebo, 500 mg or 1000 mg of oral paracetamol  1 h prior to induction. Two mg/kg of propofol was injected at a rate of 600 ml/hr. After 1/4 of the full dose had been injected, the syringe pump was paused, and patients were asked to rate pain at the injection site using a verbal numerical rating score (VNRS) from 0 to 10.P < 0.001)*. The rate of pain was lower in the P1000 group (70.4%) than in both the P500 and the placebo group *. The respective rates of mild (VNRS 1–3), moderate (VNRS 4–6) and severe pain (VNRS 7–10) were 47.2, 23.2 and 0% in the P1000 group, 28.7, 50 and 7.4% in the P500 group, and 0, 22.2 and 76.9% in the placebo group (P < 0.001* for between group comparisons). Tolerance was similar in the 3 groups.Three hundred and twenty-four patients were included. Pain intensity was lower in both P500 and P1000 groups  than in the placebo group (8 [7–10]; A premedication with oral paracetamol can dose-dependently reduce pain at propofol intravenous injection. To avoid this common uncomfortable concern for the patients, this well-tolerated, available and cheap treatment appears as an option to be implemented in the current practice.TCTR20150224002. Prospectively registered on 24 February 2015. Propofol (di-isopropylphenol) is the most frequently used agent for the induction of general anesthesia because of its rapid onset and short duration of action. However, pain from the injection is a common problem . The incPain upon injection of some anesthetic agents are thought to be a direct irritant effect by the non-physiological osmolality or pH of their preparations . NonetheA number of approaches have been proposed to lessen the injection pain such as injection of propofol at an antecubital fossa, fast injection  and pretCanbay et al.  showed tAdditionally, Seymour et al.  demonstrThis study was a double-blinded randomized controlled trial (RCT). It was approved by the Faculty of Medicine, Prince of Songkla University Ethics Committee and registered with Thai Clinical Trial Registry . The principal investigator was Dr. Nimmaanrat. The data were collected from June 2015 until February 2016 at Songklanagarind Hospital . The authors prepared this trial report in accordance to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The full protocol is accessible on request.We recruited 324 patients with the American Society Anesthesiologists (ASA) physical status I-III of who were aged between 18 and 65, scheduled for elective surgeries under general anesthesia, and having an intravenous catheter number 20G at a hand dorsum.Exclusion criteria included weight less than 50 kg, chronic pain, hypertension, cardiovascular disease or cerebrovascular disease, difficulty in communicating, cirrhosis or abnormal liver function test result (aspartate transaminese (AST), alanine transaminase (ALT) ≥ 2 times of normal range), renal failure or creatinine clearance (CrCl) ≤ 10 umol/L, paracetamol and/or propofol allergy. Exclusion criteria also included patients who were not using propofol for an induction, using an intravenous catheter that was not on a hand dorsum, or whereas the size of the catheter was not 20G and had to have a rapid sequence induction.After obtaining a written informed consent, a randomization was performed by using a block of 6 method. The drugs were prepared by one of the investigators (MJ), with both the patient and an independent assessor (anesthesiologist in-charge) blinded. The groups Pb, P500 and P1000, patients were premedicated with oral placebo, 500 or 1000 mg of paracetamol, respectively 1 h prior to transferal to the operating room. Each patient received either 2 tablets of placeco (Pb group), 1 tablet of placebo and 1 tablet of paracetamol 500 mg (P500), or 2 tablets of paracetamol 500 mg (P1000). Both placebo and paracetamol were identical in shape, size, color and weight. None of them received any other analgesic or sedative drug. A 20G intravenous catheter was inserted into a superficial vein on the hand dorsum and intravenous fluid at a rate of 80 ml/hr. was infused into each patient.After preoxygenation, an emulsion of 1% propofol in a mixture of long-chain and medium-chain triglycerides  2 mg/kg  was intravenously administered into each patient with a syringe pump at a rate of 600 ml/hr. (10 ml/min). After 1/4 of the calculated dose of propofol had been delivered, the infusion pump was temporarily paused and the patient was asked to rate his/her pain at the injection site using an 11-point verbal numerical rating score (VNRS) when 0 is not pain and 10 is the worst pain imaginable. None of them was heavily anesthetized and unable to give the VNRS. The residual dose of propofol was then given, followed by opioids and neuromuscular blocking agent as per usual.In the operating room and postanesthesia care unit, each patient was carefully evaluated for paracetamol’s side effects including rash, swelling, flushing, hypotension and tachycardia.P value less than 0.05 was considered as statistical significant. Continuous variables were presented as median and interquartile range (IQR) or mean and standard deviation (SD). Categorical variables were presented as number of patients and percentages. The power of this study was 0.9.Statistical analysis was performed by using R software 2.14.1. Continuous variables were analyzed by ANOVA F- test or Kruskal-Wallis test. Categorical variables were analyzed by ANOVA F-test, Fisher’s exact test or Chi-square test. Post-hoc analysis was carried out by using a Bonferroni correction. For sample size calculation, we collected pain intensity by using the 11-point verbal numerical rating score (VNRS) in 30 patients who received propofol for an induction, without having paracetamol for premedication. The mean VNRS in this group of patients was 5.7. Anticipating that patients premedicated with paracetamol would have 25% less pain (VNRS of 4.2), a number of patients per each group was calculated to be 96. With 10% drop out, the definite number of patients per each group was 108.A total of 834 patients were assessed for eligibility from June 2015 to February 2016. Five hundred and ten patients were excluded and 324 patients were randomly allocated to each group. Each group equally had 108 patients. All participants were completely analyzed. . The incidences of pain by categories of intensity (mild/moderate/severe) were lower in the P1000 group in comparison to those in the P500 and the Pb groups (P < 0.001). . Table .Fig. 2InP < 0.001). , 4 (2–5), and 8 (7–10), respectively There was no incidence of complications such as; rashes or edema of the tissue in each group at the recovery room.In this study, we found that an oral paracetamol was effective in decreasing the incidence and severity of propofol injection pain when compared with a placebo. Premedication with 1000 mg of paracetamol was also more effective in reducing propofol injection pain than 500 mg.-arachidonoylphenolamine (AM404) [Paracetamol is one of the most popular and frequently used pain killer throughout the world. The mechanisms of action are sophisticated and cover both peripheral and central antinocciceptive manners. The pain relief effect provided by paracetamol is via inhibition of the cyclooxygenase pathway centrally and peripherally, reducing the production of prostaglandins . Neverth (AM404) , and a m (AM404) , 25 as c (AM404) . Pain re (AM404) , 28. Oha (AM404) . Treatme (AM404) .Paracetamol has been found as effective for reducing propofol injection pain. Canbay et al.  conductemax) than the oral route.In our study, the overall incidence of pain during propofol injection was higher than other studies. The previous 3 studies , 31, 32 The other reasons that the incidence of propofol injection pain in the paracetamol group in previous studies was lower than ours may be from inserting a bigger venous catheter  and/or uAccording to the severity of pain, the incidence of mild, moderate, and severe pain was also significantly different in our P1000, P500 and Pb groups. These findings indicate that premedication with oral paracetamol reduce propofol injection pain by means of a dose-dependent fashion.Different method of assessing pain severity may also explain our different results on severity of propofol injection pain. We used a Verbal Numerical Rating Score (VNRS) ranging from 0 to 10 (11 points) to measure our patients’ pain. All of our patients verbally reported their pain by themselves (‘subjective’ assessment). The other studies used a 4-point scale . They did not mainly ask their patients to verbally rate the level of pain upon propofol injection but they principally observed their patients’ pain behaviors : 0 = none (negative response to questioning), 1 = mild pain , 2 = moderate pain , and 3 = severe pain . Measuring pain by the VNRS is reliable, valid, sensitive to change, and easy to administer . We did This study found no adverse consequence of paracetamol.Strengths of this study are utilization of a simple analgesic (paracetamol) and administered it to the patients in a simple way . Considering that oral paracetamol has been shown to increase the incidence of no pain as well as to reduce the incidence of severe pain upon propofol injection, the results of this study are clinically useful and applicable to daily practice because oral paracetamol is readily and widely available, practically simple and convenient to use as well as economic wise. As our study’s protocol is easy to apply and early administration or oral paracetamol is pharmacologically sensible, the result of this study can be clinically applied in general.Limitations of this study are a subjective method of pain intensity measurement and the fractional dose of given propofol. The intensity of propofol injection pain was rated by using the verbal numerical rating score (VNRS), although patient’s self-assessment is the gold standard of pain intensity measurement but it is subjective and depends of each individual. Because propofol is a powerful induction agent, we could not inject the entire dose of propofol to each patient before measuring the pain intensity as a significant number of them felt asleep and were unable to give the pain rating.Premedication with oral paracetamol can reduce propofol injection pain on a dose-dependent basis, without causing any adverse effect. As propofol injection pain is common and remains a concern of anesthesia providers for the comfort of their patients, and early oral administration of paracetamol is pharmacologically sensible, easy to apply, well-tolerated, available and economic, the results of this study provide the basis for changing practice with a positive impact on patient care.


Subgrouping patients with chronic low back pain is recommended prior to selecting treatment strategy, and fear avoidance beliefs is a commonly addressed psychological factor used to help this subgrouping. The results of the predictive value of fear avoidance beliefs in patients with chronic low back pain in prognostic studies are, however, not in concordance. Therefore, the objective of this study was to examine the association between fear avoidance beliefs at baseline and unsuccessful outcome on sick leave, disability and pain at 12-month follow-up in patients with entirely chronic low back pain.n = 559) completed questionnaires at baseline and after 12 months. Multiple logistic regression analyses were conducted to examine the association between fear avoidance beliefs and the outcomes sick leave, disability and pain.A secondary analysis of data from a randomised controlled trial. Patients with chronic low back pain  and having no reduction in pain  after 12 months and may be associated with having no reduction in disability  after 12 months (lower limit of 95% CI close to 1.00). Fear avoidance beliefs about physical activity were not found to be associated with the three outcomes.High fear avoidance beliefs about work are associated with continuous sick leave after 1 year in patients with chronic low back pain. This finding might assist clinicians in choosing targeted treatment strategies in subgroups of working patients with chronic low back pain.The online version of this article (10.1186/s12891-018-2351-9) contains supplementary material, which is available to authorized users. In high-income countries it is estimated that 2–5% of the population have chronic low back pain (CLBP); i.e. low back pain (LBP) for at least 3 months . DespiteScreening for psychosocial prognostic factors is recommended in the process of subgrouping patients with CLBP . One of The objective of this study was to examine the association between fear avoidance beliefs at baseline and the outcomes sick leave, disability and pain at 12-month follow-up in patients with CLBP.This study was secondary analysis of data from a randomised controlled trial  with a 1After approval by the Danish Regional Ethics Committee, The Capital Region of Denmark (File number H-C-2008-112), patients living in the municipality of Copenhagen, Denmark, were referred from general practitioner, rheumatologist or municipal sickness benefit office for treatment of persistent LBP. All patients received oral and written information about the randomised controlled trial and gave written informed consent prior to participation.The inclusion criteria were working age adults (18–65 years) with LBP for at least 3 months, on sick leave or at risk for eminent sick leave. Exclusion criteria were pending application for early retirement pension, pregnancy, comorbidity  or difficulties in reading and writing Danish.All patients completed baseline questionnaires including the following variables: age, sex, Body Mass Index, education (years after primary school), smoking, alcohol intake, leisure physical activity level, sick leave due to LBP, duration of sick leave, job status, current compensation case, physical job demands, general health status measured on the Short Form 36 , anxietyThe outcome variable sick leave was defined as unsuccessful, if a patient on sick leave at baseline was still on sick leave at 12-month follow-up. The modified Roland Morris Disability Questionnaire and the Numeric Pain Rating Scale were dichotomized according to recommended scores of minimal important change , as thisMultiple logistic regression analyses were used to examine the association between fear avoidance beliefs and the outcomes sick leave, disability and pain. The following variables were included as confounders à priori on the basis of known or presumed risk factors between fear avoidance beliefs and the three outcomes: sex, age, pain intensity , disabilr > 0.5; fourth, multiple logistic regression analyses were conducted using backward stepwise elimination  in order to identify the best fitted model with the highest explanatory value (R2); finally, tests for interaction were performed to examine whether any interaction joint increased the model fit, evaluated on Wald tests.The analyses were conducted separately for each outcome in five steps: first, test for the assumption of normal distributions of the residuals; second, univariate analyses between the outcome variables and the independent variables to compute crude estimates; third, test for collinearity between the continuous variables based on Pearson’s p-value below 0.2 in the univariate analysis; analysis with fear avoidance beliefs about work  and fear avoidance beliefs about physical activity  as dichotomous variables [The following sensitivity analyses were performed: analysis including the variables with a ariables ; finallyp-value below 0.05 was considered statistical significant. Data were analysed using the statistical package STATA/IC 14.1 for Mac .The outcomes were reported in odds ratios (OR) with 95% confidence intervals (CI). A A total of 559 patients were included in the study. The mean age of the patients was 38.9 years SD 10.4) and 47.1% were women. Median duration of LBP was 11 months (IQR 5–33). Two hundred seventy-three patients (51.4%) had a duration of LBP between 3 to 12 months and 275 patients (49.8%) were on sick leave at baseline  and being a smoker  at baseline were significantly associated with unsuccessful outcome on sick leave Table .Table 4F2 from 0.08 to 0.09.Analysing unsuccessful outcome on disability, higher fear avoidance beliefs about work showed a slight association , but the lower limit of the 95% CI was close to 1.00. Significant associations were found between higher pain intensity , lower disability , being a smoker  and having LBP for more than 12 months combined with little physical job demands  at baseline and unsuccessful outcome on disability at 12-month follow-up , lower pain intensity  and the combination of being male with little physical job demands  at baseline were significantly associated with unsuccessful outcome on pain at 12-month follow-up Additional file 2:Table S2. Dropout analysis comparing baseline characteristics of patients included in the analysis of disability to those not included. (PDF 62 kb)Additional file 3:Table S3. Dropout analysis comparing baseline characteristics of patients included in the analysis of pain to those not included. (PDF 64 kb)Additional file 4:Table S4. Simpler model of association between fear avoidance beliefs at baseline and unsuccessful outcome at 12-month follow-up. (PDF 53 kb)


Approximately one in five patients undergoing knee replacement surgery experience chronic pain after their operation, which can negatively impact on their quality of life. In order to develop and evaluate interventions to improve the management of chronic post-surgical pain, we aimed to derive a cut-off point in the Oxford Knee Score pain subscale to identify patients with chronic pain following knee replacement, and to characterise these patients using self-reported outcomes.Data from the English Patient-Reported Outcome Measures (PROMs) programme were used. This comprised patient-reported data from 128,145 patients who underwent primary knee replacement surgery in England between 2012 and 2015. Cluster analysis was applied to derive a cut-off point on the pain subscale of the Oxford Knee Score.A high-pain group was identified, described by a maximum of 14 points in the Oxford Knee Score pain subscale six months after surgery. The high-pain group, comprising 15% of the sample, was characterised by severe and frequent problems in all pain dimensions, particularly in pain severity, night pain and limping, as well as in all dimensions of health-related quality of life.Patients with Oxford Knee Score pain subscale scores of 14 or less at six months after knee replacement can be considered to be in chronic pain that is likely to negatively affect their quality of life. This derived cut-off can be used for patient selection in research settings to design and assess interventions that support patients in their management of chronic post-surgical pain.The online version of this article (10.1186/s12891-018-2270-9) contains supplementary material, which is available to authorized users. Pain and functional limitations due to knee osteoarthritis (OA) is a leading health concern and a major global contributor to years lived with disability . For peoWith approximately 700,000 KR performed per year in the US  and 108,Often patients do not seek care for chronic pain . The abiThe aim of this study was to identify a cut-off point on the pain subscale of the commonly-used Oxford Knee Score (OKS) that can be used to identify patients with high levels of pain 6 months after KR.Data were obtained from the patient-level, anonymized English NHS Patient-Reported Outcome Measures (PROMs) programme available from the NHS Digital website . All patPatients undergoing primary KR, with complete post-operative OKS were included in the present study. There were no restrictions on age or sex. The dataset did not include the indication for or type of surgery performed, hence records were included regardless of the underlying condition or type of KR. As the unit of analysis was KRs and records were fully anonymised, it was not possible to determine if patients had their contralateral knee replaced within the same period of analysis. It was therefore possible for patients to be included twice in the dataset.The OKS is a 12-item score which measures knee pain, stiffness, and functional disability within the previous 4 weeks . ResponsPrevious work has identified pain- and function-related subscales within the OKS , with fuTo identify the high-pain group, hierarchical clustering was used to group patients into clusters based on the similarity of their OKS-PS item scores. Hierarchical clustering is commonly used, easily interpretable and has been applied in several previous studies on knee pain in order to identify pain profiles, and broader subgroups which are then examined for correlation with pain –21. ClusFor each set of clusters (2 to 28), the distribution of the OKS-PS corresponding to the highest-pain cluster, i.e. that reporting the lowest values, was examined. This was used to derive a cut-off point, defined as the highest value taken by the highest-pain cluster on the OKS-PS. Changes in the cut-off point as the number of clusters varied are reported. Further details on the methodology have been published previously .k) at which the cut-off was identified. These measures are useful because the analysis produced clusters based on answers to seven different items, hence clusters were likely to report overlapping overall OKS-PS scores. This secondary analysis was also conducted as an internal validation by exploring an alternative approach to generating cut-off points using the same data, although differently ordered.Uncertainty around the cut-off point was measured undertaking a secondary analysis which repeated the hierarchical clustering on 100 random re-orderings of the sample, and by additionally applying k-means clustering, another commonly used method which adds an additional level of variability as cluster initialisation is randomly assigned in every iteration. To assess the choice of the cut-off point, sensitivity and specificity were calculated considering ‘true cases’ those patients included in the highest–pain cluster from the primary analysis at the lowest number of clusters , and the EQ-5D summary score comprising mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D dimensions are scored using a 1–3 Likert scale  and a suDuring the study period, 128,145 records from primary KR patients were reported in the PROMs dataset with returned post-operative questionnaires. Of these, 2081 (1.6%) records were excluded as they were missing ≥1 answers for the OKS-PS items. Therefore, 126,064 records were used for analysis, of which 54% were from females and 73% from patients aged 60–79 years. Table k = 2 clusters, the OKS-PS distributions for the two clusters have a large overlap. As the number of derived clusters increases, the degree of overlap in their corresponding OKS-PS distributions reduces and both the mode and the upper limit shift. Figure k = 2 to k = 4. However, for k ≥ 4, the cut-off point remains constant at OKS-PS = 14, implying that the OKS-PS score range of 0–14 characterises the high-pain cluster whether the sample is split into four or more clusters. Using OKS-PS ≤ 14 to identify participants in chronic pain led to a sensitivity of 100% and specificity of 89%.Figure k-means was applied the mean cut-off was OKS-PS = 14.7 (SD = 0.9). The Figure also illustrates that these cut-off points are not constant with increasing numbers of clusters. At OKS-PS = 18.5, sensitivity and specificity were 100% and 74%, whereas at OKS-PS = 14.7 they were 100% and 89%, respectively.The cut-off points obtained through secondary analysis were different to that obtained through the primary analysis. As Fig. Using the OKS-PS cut-off of 14, a total of 18,522 out of 126,064 (14.7%) patients with KR were found to be in the high-pain group. Table Age and sex were largely similar between both groups, with the exception of a larger proportion of 50–59 year olds and lower proportion of 70–79 year olds in the high-pain compared to the lower-pain group. Pre-operatively, patients in the high-pain group reported worse pain, function and health-related quality of life. Post-operatively, outcomes were also poorer for the high-pain group. A higher percentage of the high-pain group judged the outcome of their operation as ‘fair’ or ‘poor’, and perceived little or no improvement in their symptoms from their pre-operative status. Figure Using data from a large cohort of patients in England, we have developed a standardised and robust method to identify people with chronic pain following primary KR. Clusters of patients were produced according to their responses to pain-related questions in the OKS. A specific group with the lowest OKS-PS, indicating high pain, was identified. Characterisation of this group showed an association with poor health-related quality of life. A cut-off was derived such that a patient with an OKS-PS score ≤ 14 6 months after KR could be considered to be in chronic pain which is likely to have a negative impact on health-related quality of life.Our secondary analysis using hierarchical clustering and based on repetitive sampling with different ordering showed that the cut-off could be higher than 14. Differences between the primary and secondary analysis were due to the random data reordering in the latter and the high probability of ties during the clustering process. Ties are highly likely when the clustering variables are discrete and can only take a few values, such as in this case the OKS items which can only take the values 0 to 4. Each iteration of the clustering analysis produced different clusters as it faced ties in a different order every time, with this variation increased by the fact that the k-means method starts the clustering from random points every time. By conducting both analyses, we are able to provide a reference point for the cut-off value as well as a measure of its variability when the data and cluster initialisation are allowed to change randomly.This cut-off point corresponds to the highest value in the OKS-PS for a participant in the high-pain group when four groups or clusters had been identified. This number of clusters is consistent with the number identified by previous studies also using cluster analysis. Egsgaard et al. identified four knee pain profiles based on biochemical and pain biomarkers, physical impairments, and psychological factors , whilst Identifying patients with chronic pain after KR revealed marked differences between the high- and lower- pain groups not only 6 months after the operation but also pre-operatively and with regards to patients’ assessment of their outcomes. Expectedly, all measures of post-operative pain and health-related quality of life were worse for patients in the chronic-pain group. They reported significantly worse scores than their counterparts in all items of the OKS-PS items as well as in all health-related quality of life dimensions. Patients with chronic pain were characterised by high pain intensity and frequency, with severity, night pain, and limping as the most serious problems. Regarding health-related quality of life, those in chronic pain reported least problems in self-care and anxiety/depression but were still notably worse than the low pain-group in all dimensions of health-related quality of life. After the operation, one in six individuals with chronic pain reported scores considered to be worse than death.There were some difficulties in applying the cut-off on the OKS-PS to identify patients in the highest-pain cluster. Specificity of 89% revealed that some of those scoring ≤14 in their OKS-PS were not in this highest-pain cluster but in others with likely similar characteristics. The heterogeneity of outcomes after surgery for the group scoring ≤14 reflects this. Despite function remaining essentially unchanged, 32% of patients reporting their problems being worse after surgery and 60% perceiving their operation either “fair” or “poor”, in average their pain improved and 48% indicated that their problems had also improved after surgery. Therefore, this high-pain group did much worse than their counterparts, but many of them reported some improvement after surgery.This problem could potentially be attenuated if several cut-off points based on various patient characteristics were identified. Such an approach has been used previously to identify thresholds for satisfaction after joint replacement, stratified by subgroups of baseline or change scores . The autConducting a complete-case analysis was one limitation of this study. Results may therefore be affected as patients who did not complete all items of the OKS-PS may be different to those who did. However, only 1.6% of all patients in the dataset were excluded for incomplete data, thereby making any such bias unlikely. Large population cohorts such as the one used here also often suffer from loss to follow-up. In our study, however, only two patients who completed a pre-operative form did not complete the follow-up questionnaire, suggesting the data are representative of the English population.Hierarchical cluster analysis has been used in a number of OA patient studies –21. All The lack of a gold standard or other reference point for chronic pain following KR did not allow for a formal external validation of our method using a split sample of our data. However, our secondary analysis served as an internal validation as it evaluated the method by adding a second clustering approach whilst generating random orderings of the data. Our primary result of 14 fell within the ranges of values obtained from either method for all numbers of clusters between four and 19. In order to assess the generalisability of the cut-off point we identified as a screening tool for people with chronic pain following KR, a validation study using an external cohort is recommended.Using the cut-off point of 14 in the OKS-PS identified in the primary analysis, 15% of primary KR patients in England between 2012 and 2015 had chronic pain 6 months after their operation. This result is consistent with previous findings: a systematic review .This study developed a cut-off score on a commonly used PROM to provide researchers with a standardised and validated approach to the identification of patients with chronic pain after TKR. We used a population-based observational cohort to identify a cut-off point in the Oxford Knee Score pain subscale of 14 at 6 months after KR which can be useful to select patients with chronic pain. Our secondary analyses indicated that the cut-off can be higher than 14. This cut-off point will facilitate the inclusion of a targeted group in clinical trials to help investigate pain characteristics, biological mechanism and evaluate interventions designed to improve support and management for people with KR who experience chronic pain. Given the growing number of KR operations being performed and the negative association found between chronic post-surgical pain and health-related quality of life, targeted interventions are likely to benefit many people. Identifying these individuals using a simple and commonly used questionnaire such as the OKS will also allow for the conduct of future qualitative studies to assess how the profile described here matches individuals’ experiences, outcomes and expectations in other settings before broader uptake in clinical practice is considered.Additional file 1:Pain component subscale items of the Oxford Knee Score. Description of the items from the Oxford Knee Score included in the Pain component subscale showing their respective scoring categories. (DOCX 13 kb)


To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies.  A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time. p < 0.0001 for reduction over time). The effect was associated with a reduction in severity of patients' symptoms evaluated with the O'Leary-Sant questionnaire  and the PUF scale . m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity.  A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment ( These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products. The severity of disease progressively evolves from early to late stage . The preThe pathogenesis of IC/BPS remains to be fully understood; however, the presence of bladder and lower abdominal pain, bleeding, and thinning of the urothelium is often reported as suggestive of persistent bladder inflammation and urothelial dysfunction . In partThe above evidence suggests that pharmacological control of inflammatory processes may limit bladder damage, as well as peripheral and central sensitization. In this regard, N-acylethanolamines are endogenous lipid mediators able to promote the resolution of inflammation and restore tissue homeostasis. Among N-acylethanolamines, palmitoylethanolamide (PEA), an endogenous fatty acid amide congener of the endocannabinoid anandamide, has been reported to reduce inflammation and pain behaviors in different models of pelvic inflammation , 11. ProAn open-label design was adopted in this pilot research. It was performed at San Carlo di Nancy Hospital, Interstitial Cystitis Referral Center, Rome, Italy, and at the S. Maria degli Angeli Hospital, Division of Neurourology and Urodynamics, Pordenone, Italy. Both female and male patients aged 18 years or more with a diagnosis of IC/BPS according to the European Society for the Study of Interstitial Cystitis criteria and unresponsive to first-line noninvasive treatments were enrolled. Eligible patients had to meet at least five of the following criteria: presence of suprapubic, pelvic, urethral, vaginal, or perineal pain for more than 6 months; urinary urgency in more than 50% of micturitions; daytime frequency (>10 times-day) and nighttime (>2 times-night), pain with bladder filling that improves after voiding; presence of glomerulation on cystoscopy with hydrodistention under anesthesia, cystometric bladder capacity ≤300 ml, and sensory urgency (first stimulation ≤100 ml). Only patients able to read, understand, and sign an informed consent were included. Exclusion criteria were as follows: age <18 years, pregnant or breastfeeding women, bladder tumors both benign and malignant, radiation cystitis, vaginitis, symptomatic bladder diverticula, genital herpes in the active phase, bladder and urethral stones, micturition frequency <10 times a day, symptoms present for less than six months, cystometric capacity ≥300 ml with the absence of sensory urgency, the presence of symptoms from less than six months, and intolerance to treatment or active ingredient.The study was conducted in accordance with the Declaration of Helsinki. All patients signed a written consent for participation in the study. The study was notified to Ethics Committees of both centers. A baseline visit was carried out before treatment start, 15–20 days after the screening visit. The first patient was enrolled on 2010 March, and the last patient completed the study on 2013 July.Eligible patients received a single tablet containing 400 mg m-PEA plus 40 mg polydatin  twice daily for three months followed by once daily for three months.An initial screening visit was performed to determine patient eligibility and obtain informed consent. In addition to clinical examination and history, a renal and vesical ultrasound scan was carried out on all patients; urodynamic test, cystourethroscopy, and vulvoscopy were performed at the discretion of the clinician. Complete urine analysis and urine culture with ABG as well as vaginal and urethral swabs to detect common germs, protozoa, fungi, mycoplasma, and ureaplasma were carried out as part of the initial screening. Complete urodynamic testing, voiding pressure flow, and cystoscopy were performed before study start.The primary endpoint was reduction in pelvic pain intensity evaluated by the visual analog scale (VAS) at baseline, during m-PEA-Pol treatment  and two months after stopping treatment (8 months from beginning). The patients were asked to indicate pain intensity on the scale from 0 = ‘‘no pain” to 10 = ‘‘the most painful sensation imaginable.”Secondary endpoints were changes from baseline in other urinary symptoms recorded using the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index (ICSI/ICPI) , the PelPost hoc analysis on GLMM time related curves was performed using the Tukey–Kramer adjusted test for multiple comparisons. The GLMM took into account missing values, correcting the bias due to patients who left the study prematurely. The Wilcoxon signed-rank test was used to compare mean values obtained by VAS pain intensity score, the O'Leary-Sant ICSI, and ICPI and PUF at the end of 6-month m-PEA-Pol treatment vs mean values obtained after two months of discontinuation of treatment. The SAS system  was used to conduct all statistical analyses.The results obtained by evaluating VAS pain intensity score, the O'Leary-Sant ICSI, and ICPI and PUF were analyzed using the GLMM  in order to evaluate mean changes across time. Age, gender, and center were used as covariates. p values less than 0.05.Data are expressed as mean ± standard error (SE), if not otherwise stated. Results are considered significant for Thirty-two patients of both sexes with age of 51 ± 12.8  between 21 and 73 years were enrolled in the study. Females accounted for about 94% (30/32) of enrolled patients and males the remainder (2/32). Among women, 16 were menopausal, and their age was 60 ± 6.7 years. Patient demographic and baseline clinical characteristics are reported in Overall, 27 patients, including the only two male patients, returned questionnaires properly completed at the end of m-PEA-Pol therapy (84%) and 24 (75%) underwent the last visit two months after stopping treatment.p < 0.0001) , with a further significant decrease at four months vs the previous time (p=0.0240). In the interval between four and six months, average scores continued to decrease, albeit more slowly, and comparison of mean scores was not significant (p=0.9925). Two months after stopping m-PEA-Pol treatment, the pain intensity score was 4.2 ± 0.5, a value not statistically different from that at the treatment end, as evaluated with the Wilcoxon signed-rank test (p=0.2725).During m-PEA-Pol treatment, the average pain intensity score evaluated by VAS decreased from 6.9 ± 0.4 at baseline to 4.6 ± 0.4 at the sixth month in IC/BPS patients. This reduction in mean score was highly significant ( 0.0001) . The varThe O'Leary-Sant questionnaire was used to evaluate the severity of patient symptoms and assess progress during m-PEA-Pol treatment. m-PEA-Pol therapy elicited a significant and progressive reduction of both ICSI and ICPI total scores. Average ICSI total score decreased from 11.0 ± 0.8 at baseline to 8.9 ± 0.9 at the sixth month with m-PEA-Pol therapy. Average ICPI total score decreased from 10.3 ± 0.7 at baseline (0) to 7.5 ± 0.9 at the sixth month with m-PEA-Pol therapy . Total IPost hoc analysis on both ICSI and ICPI total scores performed on consecutive times  did not reveal significant reductions . Two months after stopping m-PEA-Pol treatment, total ICSI and ICPI scores were 8.9 ± 1.0 and 8.4 ± 0.9, respectively, and not statistically different when compared to those at treatment end .p=0.013). Average bother total score decreased from 11.0 ± 0.7 at baseline to 7.7 ± 0.9 at sixth month with m-PEA-Pol therapy  to 9.7 ± 1.0 at the sixth month with m-PEA-Pol therapy . The red therapy .Post hoc analysis on bother total scores performed on consecutive times  did not show significant reductions . Two months after stopping m-PEA-Pol treatment, symptom and bother total scores were 9.7 ± 1.1 and 8.2 ± 0.9, respectively, and not statistically different from mean values obtained at the end of treatment.Total symptom and bother scores were not influenced by the other variables examined. p < 0.0005). A small but insignificant improvement was observed for changes over time of bladder capacity  or nuclear (PPARs) receptors as well as nonreceptor mechanisms, suggesting that its pleiotropic action is a critical feature that adapts this molecule for the complexity of chronic pain .The m-PEA-Pol-induced pain intensity reduction confirms the ability of this formulation to exert pain-reducing effects in chronic conditions affecting pelvic organs. This action of m-PEA-Pol has been reported in patients with chronic pain associated to endometriosis , 13, perThe principal limit of the study is the lack of a placebo group so that the possibility that reported outcomes in the patients are due to drug or to the natural course of disease cannot be completely ruled out. However, there is a general consensus on progressive and chronic nature of this complex disease, and a spontaneous healing is unlikely, especially in the participants enrolled in this study who were unresponsive to first-line noninvasive treatments.These results, although obtained in an open-label pilot survey and on a limited number of patients, inasmuch belonging to rare diseases category, highlight the potential benefit of m-PEA-Pol in patients with IC/BPS and confirm the good safety profile of the micronized PEA-based product. The finding that this group of patients with severe symptoms responded so well to the treatment suggests that this therapy is worthy of additional investigation. In fact, the present data need to be confirmed in a larger multisite placebo-controlled, double-blind clinical study.


Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN.In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm—on a 0- to 10-cm visual analog scale (VAS)—in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on.Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.NCT03228420 (registered 24 July 2017).ClincalTrials.gov identifier:  Globally, 422 million people have diabetes, resulting in USD $1.7 trillion in direct and indirect costs , a debilPeripheral neuropathy from damage to peripheral nerves may result in pain, numbness, or weakness (or a combination of these) in the affected limb. Damage may affect small (myelinated Aδ and unmyelinated C) fibers along with injury to large myelinated fibers. One of the classifications for peripheral neuropathy is based on whether the damage is to a single nerve (mononeuropathy) or multiple nerves (polyneuropathy). The causes of polyneuropathy may include metabolic , endocrine disorders , treatment-induced toxicity , infection , autoimmune disorders (Guillain–Barré syndrome and Charcot–Marie–Tooth neuropathy), compression , and trauma (trauma-induced neuropathy). Nearly half of cases of peripheral neuropathy are diagnosed as idiopathic .The American Chronic Pain Association estimates that more than 15 million people in the US and Europe have some degree of neuropathic pain. More than 2 in 100 persons are estimated to have peripheral neuropathy; the incidence rises to 8 in 100 for those who are 55 or older . The incS)-3-(aminomethyl)-5-methylhexanoic acid, is an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It is a compound that acts on the central nervous system, producing analgesic, anticonvulsant, and anxiolytic effects. Clinical studies have demonstrated the effectiveness of this drug in treating intractable limb pain from PDN resulting from both type 1 and 2 diabetes  has also been shown to be effective in treating intractable pain associated with many peripheral neuropathies, including RCTs on PDN Table  32, 33,–42. In aN = 26) to 2.4 cm (± 0.5 SEM) at 6 months post-implant (N = 18), and 78% of subjects were deemed responders [Unlike traditional low-frequency, paresthesia-based SCS that seeks to induce paresthesias in the affected pain distribution, 10-kHz SCS therapy delivers paresthesia-independent, high-frequency stimulation by use of a unique waveform and uniform pulse width . The thesponders .The current treatments for neuropathic pain secondary to PDN are suboptimal and there are substantial unmet needs . In the This is a multicenter, prospective, randomized controlled clinical study to document the comparative safety, clinical effectiveness, and cost-effectiveness of the addition of 10-kHz SCS therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy. Enrollment of subjects will occur at multiple clinical sites only after institutional review board (IRB) approval and written informed consent from subjects have been obtained. Central ethical approval was provided by Western IRB , and local IRB approvals were obtained prior to recruiting at the corresponding sites. Subjects will be selected to participate in the study on the basis of the protocol’s inclusion Table  criteria1c) level. Thus, there will be four strata per site. Concealed allocation will be achieved via computer assignment of the treatment arm, and investigational site staff and study sponsor personnel will be unaware of the block size and randomization list. Owing to the nature of the treatments, specifically an implanted medical device compared with CMM, blinding subjects or investigator teams to the treatment assignment is not feasible. Subjects randomly assigned to either treatment group will have the potential to cross over to the alternative treatment arm at the 6-month visit if they meet all of the following criteria: (1) less than 50% lower limb pain relief from baseline, (2) documented subject dissatisfaction with the treatment (“dissatisfied” or “very dissatisfied” on subject satisfaction measure), and (3) investigator agreement with crossover.Subjects meeting the requirements for inclusion and exclusion criteria will be randomly assigned 1:1 to 10-kHz SCS therapy delivered by a Senza SCS System  plus CMM or to CMM alone. The randomization for each site will be performed by a block randomization method developed by an independent statistician. Randomization will be stratified by average baseline pain VAS score and the baseline hemoglobin A1c , a 36% responder rate for the CMM-only group, 90% power, and two-sided type I error of 0.05. Interim analysis will be performed to reassess sample size assumptions when 25% of the subjects reach the 3-month primary endpoint.Outcome data will be collected at baseline, trial and implant (10-kHz SCS therapy group), and defined follow-up intervals Fig. . Data coThe primary endpoint of this study is a composite of safety and effectiveness at 3 months, specifically the percentage of subjects who respond to treatment without a clinically meaningful neurological deficit compared with baseline. A responder is defined as a subject with at least 50% reduction in lower limb pain from baseline. For each subject and all analyses, the right and left lower limb VAS scores collected during a single visit will be averaged together to generate a lower limb pain score. In addition to the primary endpoint, several secondary and tertiary endpoints will be evaluated Tables  and 7.Tt tests) will be used if the distributional properties of the data are suitable. If parametric tests are not indicated, the associated non-parametric tests  will be used. A two-sided P value of 0.05 or less for the primary endpoint will be considered evidence of statistical significance. Reported P values for all other tests will be considered nominal and unadjusted for multiple testing but without conclusions regarding statistical significance levels.Descriptive statistics will be used to summarize all subject baseline and outcome data collected during the study. Continuous variables will be summarized by using means, standard deviations, medians, and ranges. Categorical variables will be summarized in frequency distributions. Statistical tests appropriate to the endpoint being examined will be used and identified. Parametric tests  and per protocol (PP). The ITT population includes all subjects randomly assigned to the CMM and CMM plus 10-kHz SCS study groups. This is considered the safety population for purposes of reporting on any reported AEs. The PP population includes all ITT subjects who complete the 3-month primary assessment. The primary analysis population for the primary study endpoint is the ITT population. Secondary analyses will be performed in the PP population. The responder rates will be compared between groups with a Fisher’s exact test. Hierarchical testing will be carried out on the secondary endpoints listed in Table A clinical events committee (CEC) will be convened to provide oversight during the study. This expert panel will serve in an advisory role to review safety data at interim points during the study, including the review of AEs and adjudication of the relatedness and seriousness of serious AEs. If needed, the CEC will also review unanticipated serious adverse device events on an urgent basis. The CEC will consist of clinicians with expertise in pain management, neurology, and endocrinology. Data review meetings will be held at regular intervals with the option for an ad hoc meeting at any time if an imminent subject safety issue arises. The CEC will have one physician member representing the study sponsor and the other physician members will be independent of the study sponsor and clinical investigators.In the treatment of neuropathic pain secondary to PDN, 10-kHz SCS has the potential to deliver safe and effective pain relief that is non-pharmacologic and paresthesia-independent. This would be an important development in the field because currently available treatment options for this condition, including pharmacologic agents and conventional SCS, are not adequate for all patients .Pharmacologic options for treating neuropathic pain include anticonvulsants such as pregabalin, which has shown clinical efficacy in treating neuropathic pain due to PDN in high-quality studies –18, 34. Conventional, low-frequency SCS has also been tested for treating neuropathic pain in patients with PDN. Median patient-reported NRS scores were reduced by an average of 3.1 after 12 months in a small study of 15 patients  and 3.3 The study described here will help determine the efficacy of 10-kHz SCS in patients with neuropathic pain due to PDN, a currently underserved patient population. About 100 patients will be randomly assigned to each treatment arm recruited at multiple sites throughout the US, which will result in a greater power to detect statistically and clinically meaningful results compared with prior SCS studies. Follow-up will continue for 24 months to demonstrate long-term outcomes compared with prior pharmacological data. Study sites include both large academic centers and independent pain clinics in geographically diverse areas that will provide a representative patient population. A limitation of the study is the contribution of employees of the sponsor to protocol design and data analysis as this has the potential to introduce bias. Multiple measures have been taken to minimize bias: the participation of outside medical experts in the design of the study; recruitment of independent physician investigators who are responsible for patient selection, data collection, and oversight of study conduct at their sites; concealed allocation of treatment; and the involvement of the CEC to monitor study safety. The primary endpoint results will be reported for the ITT population, and secondary and tertiary outcomes will be reported for the PP population.Another potential limitation is the cost of the proposed treatment in this study versus CMM. SCS is typically an outpatient procedure during which percutaneous leads and battery are fully implanted. The device in this study is rechargeable, and the expected battery life is in excess of 10 years when used at typical therapeutic settings. This study will collect data on health-care utilization, health-related quality of life, and medication usage to address whether the upfront cost for an implanted medical device can be justified by benefit over the life of the product, similar to what has been reported previously for SCS –69 . The first subject was randomly assigned in October 2017 and the last in August 2019.Additional file 1. SPIRIT  2013 Checklist.


The differences in post-operative pain are unclear between the primiparas who underwent a primary cesarean section and multiparas who underwent their first repeat cesarean section. The study aimed to explore the possible differences in postoperative pain between primiparas and multiparas.A prospective cohort study was performed only including women who underwent cesarean deliveries under spinal anesthesia. Postoperative patient-controlled intravenous analgesia (PCIA) was administered to all subjects with 0.2 mg/kg hydromorphone and 4 mg/kg flurbiprofen; the pump was programmed as 2.0 mL/h background infusion with a loading dose of 1 mL and a lockout period of 15 min. Postoperative incision and visceral pain intensity were evaluated using the visual analogue scale, and inadequate analgesia was defined as a visual analogue scale score ≥ 40 during 48 h post-operation. Additionally, the patients’ pain statuses in postoperative week 1 and week 4 were also assessed during follow-up via telephone.P = 0.025). There was no significant difference in the combined incidence of inadequate analgesia in both types of pain between the multiparas and primiparas . No difference was found in PCIA use between the two groups . In addition, a significantly higher incidence of pain was noted 4 weeks post-surgery in primiparas than that in multiparas .From January to May 2017, a total of 168 patients (67 primiparas and 101 multiparas) were included. The relative risk for multiparas to experience inadequate analgesia on incision pain was 0.42 (95% CI: 0.25 to 0.74) compared to primiparas. In patients aged < 30 years, inadequate analgesia on visceral pain was higher in multiparas than in primiparas (RR, 3.56 [1.05 to 12.04], Multiparas who underwent their first repeat cesarean section have a lower for inadequate analgesia on incision pain during the first 48 h after surgery than primiparas. Multiparas aged under 30 years may be more prone to experiencing postoperative inadequate analgesia on visceral pain.NCT03009955, Date registered: December 30, 2016.ClinicalTrial.gov:  Cesarean section is the most common impatient surgical procedure globally. In 2016, the cesarean delivery rate in the United States was 31.9% , 8. TherIn China, a new clinical challenge for the treatment of pain after a cesarean section has emerged, following the implementation of China’s new national two-child policy , 10. ManIntravenous or intrathecal analgesia with opioids is recommended and is a commonly used method for pain treatment after cesarean delivery. However, currently, most female patients receive a one-size-fits-all approach for analgesia after cesarean section, regardless of primiparas or multiparas. In the recent Practice Guidelines for Obstetric Analgesia and Anesthesia, there was no specific explanation for the possible difference in postoperative pain between the patients who underwent repeat and primary cesarean sections , 14. TheClinicaltrial.gov (ID: NCT03009955).This study was conducted according to the STROBE recommendations , 18. ThePatients were included according to established inclusion and exclusion criteria. From January to May 2017, 168 Chinese patients, aged 20 to 40 years scheduled to undergo elective cesarean section with a transverse incision were recruited for this study .After the fetal section and once daily after the surgery, oxytocin  was routinely administered while the patient was admitted to the obstetrics ward. PCIA was started immediately after surgery with a mixture of hydromorphone (0.2 mg/kg), flurbiprofen (4 mg/kg), and 0.9% normal saline at a dose volume of 200 mL, using a controlled infusion pump. The pump was programmed to a loading dose of 2 mL, background infusion rate of 2.0 mL/h, and PCIA dose of 1 mL, with a lockout period of 15 min. For the prevention of the postoperative nausea and vomiting, 3 mg of droperidol was administered at the outset of PCIA. Patients were monitored for 6 h in the postanesthesia care unit of the obstetrics ward after surgery. When pain was treated inadequately, the patients were administered additional pain treatment with tramadol 50 mg in a timely manner.Standardized training for follow-up assessment was performed for all included investigators. A pain visual analogue scale  was used to evaluate postoperative pain at 4, 8, 12, 24, and 48 h. The primary outcome was the incidence of inadequate analgesia (defined as a pain VAS score ≥ 40)  during tAssessment with the hospital anxiety and depression scale (HADS) before the operation was performed in all patients. The HADS includes 14 assessments, including the symptoms of anxiety and depression  with subscale scores of 8 indicating possible anxiety or depression . The intThe results of routine blood examinations before and 24 h after the surgery were retrospectively collected for all patients. The leukocyte and neutrophil counts were analyzed. At 1 week and 4 weeks after surgery, patients were interviewed by telephone and asked the following questions from a standardized questionnaire: Was there an existing pain? Was the location of pain at the incision, viscera, both, or none? Was sleep affected? Were they able to perform the activities of daily life with full autonomy, partial dependency, or absolute dependence?The sample size was calculated according to the design of chi-square test for four-fold table data in a cohort study. Since previous studies reported the incidence of moderate to severe pain under postoperative analgesia for primipara as approximately 50% , 5, the P-value less than 0.05 was considered statistically significant. The mean ± standard deviation (SD), median (interquartile range), and number (frequency) were used to summarize the variables. The patients who were scheduled to undergo a primary cesarean section were designated as group P in the final analysis, while the patients scheduled to undergo repeat cesarean section were designated as group R. The primary outcomes  were respectively described and analyzed. Logistic regression analysis using enter model was performed to evaluate the role of group P or group R in the prediction of postoperative inadequate analgesia. The presence of postoperative inadequate analgesia on incisional and visceral pain was considered as the outcome variable. BMI, age, gestational age, surgery time, preoperative complications (yes/no), depression (yes/no), and anxiety (yes/no) were also considered in the model. Odds ratios (OR) with 95% confidence intervals (CIs) were determined based on the logistic regression analysis.Statistical analysis was performed using SPSS for Windows version 19.0 . A two-tailed An independent-sample t test was used to compare the differences in demographic and preoperative data between group P and R. Due to abnormal distribution, HAD scale, incision pain VAS at rest, and visceral pain VAS were compared using a Mann-Whitney U test. Propensity score matching (PSM) analysis was performed using STATA version 12 . Group P and group R were matched by propensity scores, and factors used to generate the propensity scores were those preoperative factors which had significant difference between the two groups. These factors included age, gestational age, and preoperative complications. Patients were matched in a 1:1 ratio without replacement. The caliper was defined as 0.2. The absolute standardized difference was calculated, and the absolute standardized difference less than 10% was considered to support the assumption of balance between the two groups. Then, other postoperative outcomes including the start time to feel pain, early walking time, hospital stays and PCIA administration were compared between groups P and R.Differences in the incidence of postoperative inadequate analgesia, sleep quality, adverse events, and long-term pain status between the two groups were analyzed using Pearson’s chi-squared test. Furthermore, RR values and 95% CI for the probability of the occurrence of inadequate analgesia on incision pain and visceral pain during the postoperative 48-h follow-up were calculated, as well as the postoperative pain status at 1 and 4 weeks. Subgroup analysis according to age group (≤30 years or > 30 years) was performed. Two-way repeated analysis of variance (ANOVA) with post hoc LSD testing was used to compare the preoperative and postoperative systolic pressure, diastolic pressure, heart rate, respiratory rate, and leukocyte and neutrophil counts between the two groups.P = 0.739) could not complete the study either because they could not be contacted or they withdrew from the study. The demographic and preoperative data of all patients are shown in Table P = 0.696).Among the 67 primiparas who were scheduled to undergo cesarean section, 54 underwent the procedure due to preoperative complications  and 13 due to social factors. For the 101 multiparas, all underwent the procedure due to the history of a previous cesarean section. Fifty-four also had accompanying preoperative complications. As shown in Fig. P = 0.001), and the predicted accuracy rate based on this model was 80.8%, while the overall model was not significant (P = 0.589) for visceral pain. As summarized in Table Enter logistic regression models were applied to explore the possible predictors for postoperative inadequate analgesia on incisional pain and visceral pain. For the model of incisional pain, the statistical test for the overall model was significant (P = 0.001) compared to primiparas. As shown in Fig. P = 0.078) compared to that for patients in group P. In addition, no significant difference was found in the total combined incidence of inadequate analgesia between groups P and R .The results of subgroup analysis showed that group R was associated with a lower incidence of inadequate control on incision pain in both age groups  compared to primiparas in this matched cohort. There was no significant difference in the incidence of inadequate analgesia on visceral pain between the two groups (P > 0.05). In addition, there was no significant difference in the incidence of adverse effects between the two groups. No respiratory depression, excessive sedation, or agitation was found in the present study. In addition, no significant difference was found in the time elapsed prior to the onset of pain, early waking time, sleep quality, and PCIA administration between the two groups. The results showed the mean hospital stay for primiparas was longer than that for multiparas.After propensity score matching according to preoperative factors, including age, gestational age, and preoperative complications, no significant differences remained between the two groups, and a total of 45 pairs of subjects were included for comparison of other postoperative outcomes (Table P = 0.004), time effect (P < 0.001), and group and time interaction effect (P = 0.024). For the neutrophil count, the group effect (P = 0.012) and time effect (P < 0.001) were significant, while group and time interaction effects were not significant (P = 0.023). As shown in Fig. 9/L vs. 8.38 ± 2.57 × 109/L, P = 0.202) and neutrophil  counts between the different groups before the surgery, while both leukocyte  and neutrophil  counts at 24 h after the surgery in group P were significantly higher than that in group R.Two-way repeated ANOVA for leukocyte count showed a group effect P = 0.00, time efAs shown in Table In additional, a significant difference was noted in the location of pain between patients in group P and group R.Our results show that the total incidence of inadequate postoperative pain control was 36.3% using PCIA combined with hydromorphone and flurbiprofen, which was demonstrated as an effective combination for postoperative pain control . One preAs we know, a high proportion of female patients are scheduled to undergo secondary cesarean section because of a previous cesarean section. In the United States, a repeat cesarean section due to a previous uterine scar contributed to more than 30% of all cesarean sections , 25. SevFor patients undergoing cesarean section, oxytocin, which can induce contraction pain, was routinely used to reduce intraoperative and postoperative hemorrhage , 31. ThuOne previous study demonstrated that compared to primiparous women, the analgesic effect on post-cesarean uterine cramping pain is less in multiparous women . The curIn contrast, this study showed that multiparas were less likely to experience inadequate treatment on incision pain. The RR for multiparas was 0.42 (95% CI: 0.25 to 0.74), and the mean incision pain VAS score in group R was significantly lower than that in group P at several time points, including 4, 12, and 24 h after surgery. Based on the results of the current study, several reasons might account for this phenomenon. First, as shown in the study, the rate of preoperative complications in group P was higher than that in group R (80.6% vs. 53.5%) and was identified as a significant risk factor for inadequate treatment on incision pain. Second, through retrospective analysis, we found that both the leukocyte count and neutrophil count were significantly increased 24 h post-operation compared to that prior to surgery, and these elevations were higher in group P than in group R. Previous studies , 39 haveIn summary, because of the difference between postoperative control on visceral and incision pain, there was no significant difference in the combined incidence of inadequate analgesia on both types of pain between patients in groups P and R. Regarding the other postoperative outcomes during the hospital stay, no significant difference was found in the incidence of adverse events, time to feel pain, early walking time, sleep quality, and PCIA administration between the two groups. However, we found that the mean hospital stay for primiparas was longer than that for multiparas. This indicated that primiparas might need more care after cesarean section. Furthermore, the current study demonstrated that primiparas might experience a longer duration of pain, because higher incidences of existing pain and affected sleep were found in group P than in group R 4 weeks after surgery. This might be due to the higher incidence of inadequate incision pain control in patients of group P, because a previous study has identified inadequately controlled acute postoperative pain as a risk factor for the development of chronic pain post-operation .Several limitations should be noted in the study. First, the study only included Chinese women from urban areas; thus, race and socio-economic status should be considered when interpreting the current results , 45. SecMultiparas under 30 years of age may be more prone to experiencing moderate to severe visceral pain under PCIA with opioids during the first 48 h after surgery compared to primiparas; however, primiparas have a higher incidence of inadequate treatment on incision pain and possibly a higher incidence of existing pain 4 weeks after surgery. Based on the results of the current study, individual differences between primipara and multipara should be considered in postoperative analgesia in the future.


Mental health has been shown to improve after total hip arthroplasty (THA). Little is known about the role of pain and function in this context. We assessed whether change in mental health was associated with improvement in pain and function 1 year post-surgery.This prospective study included patients enrolled in a THA registry from 2010 to 2014. We examined the mental component score (MCS) before and 1 year post-surgery, and 1-year change, in association with Western Ontario McMaster Universities (WOMAC) pain and function scores. All scores were normalized, ranging from 0 to 100 (larger score indicating better outcome). Analyses were adjusted for potential confounders.Our study included 610 participants, of which 53% were women. Descriptive statistics are as follows: the average (SD) for age (years) was 68.5 (11.8), and for BMI was 26.9 (4.9). In addition, the MCS average (SD) at baseline was 44.7 (11.2), and at 1-year after THA was 47.5 (10.5). The average change from baseline to 1-year post-THA in MCS was 2.8 , for an effect size of 0.26. As for the WOMAC pain score, the average change from baseline to 1-year post-THA was 44.2 , for an effect size of 2.5. The equivalent change in WOMAC function was 38.1 , for an effect size of 2.0. Results from multivariable analysis controlling for covariates showed that an improvement of 10 points in the 1-year change in pain score resulted in a 0.78 point  increase in the 1-year change in MCS, whereas a 10-point improvement in the 1-year change in function was associated with a 0.94 point  increase.Mental health significantly improved from baseline to 1-year post-THA. Greater improvement in pain and function was associated with greater improvement in mental health 1 year post-THA. Poor mental health is reported among patients with pain and functional disability –3, and iPrevious research on mental health status in OA concentrated either on assessing mental health status before and after TJA –16 17–2–217–22 on = 1045) received questionnaires, which were sent between 10 and 14 days prior to surgery. Of those, 848 questionnaires were returned (81.1%). One year after surgery follow-up questionnaires were sent to all eligible patients, to which 785 (75.1%) responded. Overall, 636 (60.9%) of the eligible patients with THA responded to both the preoperative and the 1-year postoperative questionnaire, with 610 people having data on mental health status and pain or function data and were included in this study.As part of a prospective THA cohort that began in 1996 at a large public hospital in Switzerland, data before and after surgery were systematically collected on all THAs performed at the institution . For thiAt baseline and 1 year after surgery, patients completed patient-reported outcomes using questionnaires. Mental health status was assessed using the mental component score (MCS) of the Medical Outcomes Study Short Form-12 (SF-12) , which iThe main outcomes of interest were the MCS at baseline, 1 year after THA, and 1-year change. The MCS ranges from 0 to 100, with higher scores indicating better outcomes. We calculated the change as the absolute difference in MCS scores between baseline and 1 year after THA. The mean ± SD population value in this geographic study area  was 46.3The main predictors of interest included the WOMAC pain and function scores at baseline, 1 year after THA, and the 1-year change. We calculated differences in WOMAC pain and function scores as the absolute difference between baseline and 1 year post-op pain and function scores, respectively. We took into consideration participants’ age, sex, body mass index , education level , insurance status (private or public), smoking status (ever or never), medical co-morbidities such as diabetes (yes or no), the American Society of Anesthesiologists (ASA) score  , medicatPreoperatively, the questionnaire was sent out to all patients undergoing elective THA approximately 10 to 14 days prior to surgery. The follow-up questionnaire was sent out 1 year after surgery to all patients still alive. For patients who did not return their 1-year questionnaires, another follow-up questionnaire was sent about 3 months after the first mailing. Information on the baseline characteristics including age, sex, and insurance status was recorded at the time of admission. Reason for OA and Charnley disability grades were recorded on a pre-specified form by the operating surgeon. Medical co-morbidities, medication use at the time of admission, BMI, ASA score and smoking status were obtained from the anaesthesia report and discharge summary. Information on education level was obtained from the patient via the preoperative questionnaire.Regarding the first aim , we calculated means and standard deviations (SD) for baseline, 1 year after surgery, and 1-year change in MCS scores overall, and by subgroups defined by age, sex, BMI, education, insurance, smoking status, ASA scores, diabetes, antidepressant or opioid use, Charnley scores, and OA status. To show the magnitude of the overall 1-year difference, we estimated Cohen’s effect size where 0.2, 0.5, and 0.8 were considered respectively as small, medium, and large differences between baseline and 1 year after THA . We alsoRegarding the second aim , we calculated means and standard deviation (SD) for baseline, 1-year, and 1-year change in WOMAC pain and function scores. We then examined 1-year change in MCS by quartiles of 1-year changes in pain and function. We also used 2 separate linear regression models to predict 1-year change in MCS as the main outcome of interest, one model with 1-year change in pain and the other with 1-year change in function as the main predictor of interest. We performed both unadjusted linear regression, and adjusted for education, age, BMI, sex, smoking status (ever vs. never), insurance status (private vs. public), diabetes, ASA score (1 vs. 2+), and Charnley score (C vs. A and B), OA status (primary vs. secondary). By visual inspection, the distributions of regression residuals of these models were reasonably bell-shaped. Finally, as education level was an important covariate and approximately one fourth of our participants were missing education data, we further performed sensitivity analyses using a simultaneous multiple imputation for the education level. In brief, we entered education, age, and BMI as continuous variables in addition to sex, insurance, tobacco, ASA, diabetes, hypertension, and Charnley score into the model with 1-year change in pain or function predicting 1-year change in MCS score to perform multiple imputation of missing data for multivariable adjusted linear regression. We used IBM Windows SPSS V.22  for all statistical analyses.We included 610 participants in the study. Of those, slightly over half of them were women, 1/3 of participants were younger than 65 years, 23% were overweight or obese, 26% had less than 9 years of education, 85% had public insurance, and 2/3 never smoked. Moreover, approximately 10% of participants had diabetes, used antidepressants, used opioids at baseline, or had THA for reasons other than primary OA.Regarding the first aim, MCS scores prior to THA had an almost uniform distribution between values of 30 and 60 Fig. . One yea).Regarding the second aim, the following are descriptive statistics for WOMAC pain and function, and 1-year change in MCS scores by quartiles of 1-year changes in pain and function. For WOMAC pain, mean (SD) at the baseline was 39.6 (18.3), and at 1-year post-THA it was 83.8 20.4). The change in pain from baseline to 1-year post-THA was 44.2 . For WOMAC function, mean (SD) at baseline was 40.2 (18.8), and at 1-year post-THA it was 78.3 (22.1). The change in function from baseline to 1-year post-THA was 38.1 . Results for the change in MCS scores by quartiles of WOMAC pain and function improvement indicated that mental health improvement was greatest in the patients with the most improvement in pain or function 1-year post-THA. In fact, the increasing trends in MCS change with a decrease in pain or increase in function were both statistically significant (Table 0.4. The Results from multivariable analysis showed that improvements in pain and function were strongly associated with improvements in mental health Table . On averMental health improved from baseline to 1 year after THA. The observed change in mental health was similar in patients with and without antidepressant use. The magnitude of the change in mental health was strongly associated with the degree in improvement of pain and function. Moreover, alleviating pain and improving function was associated with improved mental health after taking into account differences in baseline characteristics.We are not aware of any previous publication evaluating the associations between pain and function improvement and mental health gain after THA. Previous studies have assessed quality of life before and after THA and they have included MCS scores among other instruments –19, 20––20–22 ThRegarding the link between pain and depression, a previous study of Canadian patients suggested that pain may have an indirect effect on depression via its effect on disability . In anotThe strengths of our research study included the representativeness of our study population with that of the surrounding Swiss population , especiaIn conclusion, mental health improved from baseline to 1-year post-THA. The degree of improvement in mental health was strongly associated with the degree of improvement in pain and function, taking into account potential confounders. Thus, improvement in mental health can be an important benefit of surgical intervention. As a consequence, depression or mental health distress frequently seen in patients with osteoarthritis may be successfully altered by hip replacement surgery.


Inguinal disruption (ID) is a condition of chronic groin pain affecting mainly athletes. ID cannot be defined as a true hernia. Pathogenesis is multifactorial due to repetitive and excessive forces applied to the inguino-pelvic region. Examination reveals tenderness to palpation of the inguinal region. Differential diagnosis is challenging; imaging is helpful for excluding other pathologies. Surgery is the treatment of choice when conservative treatment fails. Primary aim of the study was to evaluate the time to return to full sport activity after transabdominal preperitoneal patch plasty (TAPP) technique in ID. Secondary aim was to evaluate the postoperative complication rate both in the immediate post-operative time and in 1 year follow-up and to verify the relapse rate after surgery. In this study, we consider time to return to full sport activity as the time needed to return to pre-injury sport activity.A retrospective study is reported by evaluating 198 cases of ID from a single surgeon experience. All patients failed a previous conservative treatment. All cases were treated with the TAPP approach. Time to return to full sport activity was 4 weeks for 94.4% of patients, with a total of 98.5% of active patients at 9 months. Post-operative inguinal pain was the main complication (9.1%). On 13 years follow-up, we report a recurrence rate of 2.5%.Current management algorithm for ID, in professional athletes, supports the role of surgery after at least 2 months of conservative treatment. Recently, the role of surgery has been highlighted for a definitive treatment and a faster full recovery to sport activity, especially for elite professional athletes. In our opinion, laparoscopic surgery is the mainstay for non-responsive ID treatment. We present a long-term retrospective evaluation of a wide cohort of professional athletes diagnosed and treated in a systematic way. Surgery is the treatment of choice for ID when conservative treatment failsLaparoscopic technique offers an advantage over open surgery in terms of faster rehabilitation, earlier return to daily and full sport activitiesTAPP repair should be performed bilaterally in ID in order to have a better outcomeInguinal disruption (ID) is a clinical condition of chronic groin pain affecting many athletes, both professional and amateur . In liteID is often found in athletes who undertake sports involving kicking and twisting movements while running . ID accoBecause of the absence of an abnormal exit of tissue through the abdominal wall in the inguinal region, ID cannot be defined as a “true” hernia . PathogePatients report monolateral groin pain at the pubic symphysis radiating through the scrotum, the perineum, the rectus abdominis and the adductor tendon (according to nerve distributions) with associated resistance or pain on ipsilateral hip adduction , 12. SymDiagnosis of ID is a clinical challenge, and for this reason, the BHS has proposed diagnostic criteria for sports hernia Table  4]. It . It 4]. The BHS proposed a treatment algorithm Table  4]. ID . ID 4]. Since the LT is associated to a quicker recovery and return to sporting activity, the primary aim of the study was to evaluate the time to return to full sport activity after the TAPP technique in ID. Secondary aim was to evaluate the postoperative complication rate both in the immediate post-operative time and in 1 year follow-up and to verify the relapse rate after surgery. In this study, we consider time to return to full sport activity as the time needed to return to pre-injury sport activity.n: male/female 185/13) were retrieved between May 2004 and July 2017. All patients were sportsmen from different levels of competition, both amateurs and professional . All surgical procedures were performed by the same surgeon (Giuseppe Massimiliano Sansonetti) at “Ospedale Bassini” (between 2004 and 2012) and “Casa di Cura Igea” (between 2012 and 2017) in Milan . All patients were referred to our attention from Professional Sport Medical Services and Physiotherapy Service. One hundred eighty-three patients (92.4%) were submitted, before surgery, to dynamic abdominal wall ultrasound (dUS) evaluation performed by a skilled radiologist. During dUS, a real-time convex anterior bulge and ballooning of the inguinal canal was observed at the superficial inguinal ring. dUS showed, in 175 patients (88.4%), a bilateral or monolateral inguinal bulge with evidence of peritoneal fat ballooning during Valsalva manoeuvre. dUS was negative in 8 cases; further abdominal magnetic resonance imaging (MRI) confirmed an inguinal ballooning in 5 cases, with exclusion of further concurrent skeletal-muscle injuries. A total of 15 patients were not submitted to a preoperative dUS. These cases belong to the first surgical period when treatment was not fully standardized; it is therefore a partial limitation of this study. All patients underwent bilateral TAPP repair. The mean age of the patients was 24 years (range 14–42 years). Male patients were as follows: 105 soccer players (53.0%), 20 runners (10.1%), 7 tennis players (3.5%), 5 cyclists (2.5%), 2 boxers (1.0%), 1 jockey (0.5%), 1 basketball player (0.5%), 19 athletes from other specialties (9.7%) and 25 amateur athletes (12.7%). Female patients were as follows: 3 dancers (1.5%), 3 gymnasts (1.5%), 3 marathoners (1.5%), 2 tennis players (1.0%) and 2 amateur athletes (1.0%) . Data were analysed using the Microsoft Excel for Windows Version 8.0 .A retrospective study was performed evaluating all patients with ID submitted to laparoscopic surgical treatment with the TAPP technique. A total of 198 patients , 53 bilateral inguinal pain (26.8%), 14 pubalgia (7.1%), 5 scrotal and perineal pain (2.5%) and 5 hypogastric pain (2.5%). At the first surgical visit, 143 patients (72.2%) presented ID symptomatology with inguinal bilateral impulse during Valsalva manoeuvre whereas 55 patients (27.8%) presented monolateral inguinal symptoms. In all cases, the symptomatology was referred invalidating.2 ± 10%; mean pore area 1.5 mm2; mean pore dimension 2.76 mm; mean thickness 0.56 mm ± 10%) was tailored and positioned bilaterally. The mesh was then fixed by applying n-hexyl/cyanoacrylate glue  in order to prevent recurrences and reduce possible stapling complications  or vascular lesions (“triangle of pain” and “triangle of doom”). The peritoneal incision closure was achieved by overlapping the peritoneal flaps, and fixation was performed, with a tension-free technique, with surgical glue . In order to facilitate the peritoneal closure, the pneumoperitoneum was reduced to 12 mmHg.All patients were treated with the standard TAPP technique under general anaesthesia Fig. . A 14-mmAll patients underwent conservative treatment with anti-inflammatory drugs , rest and physiotherapy protocols  for at least 6 weeks . HoweverMean operative time was 90 min (range 50–140). Fluid oral intake was administered in post-operative day (POD) 0 with full solid diet on POD 1. Mobilization was performed in POD 0. One hundred ninety-seven patients (99.5%) were discharged in POD 1 with no postoperative complications. One patient’s discharge (0.5%) was delayed to POD 5 following haemorrhage in POD1 with laparoscopic revision and haemostasis of testicular vessels’ bleeding.One patient (0.5%) was readmitted at POD3 with small bowel occlusion; the patient was submitted to laparoscopic revision with evidence of an internal hernia in the preperitoneal right space due to detachment of the peritoneal flap. The internal hernia was corrected, and the peritoneal flap was closed with surgical glue. Following postoperative progress was uneventful.The mean return time to routine daily life was 48 h (range 24–120) with postoperative pain being the main delaying factor.Follow-up regimen was characterized by a clinical evaluation and was scheduled as follows: 7–10 days, 1 month, 3 months and 12 months.A total of 24 patients (12.1%) referred an early complication at follow-up day 7: 3 patients (1.5%) had a small periumbilical haematoma with spontaneous resolution; 3 patients (1.5%) had a subcutaneous seroma in the inguinal region (1 was treated with needle evacuation while 2 resolved spontaneously); 18 patients (9.1%) had inguinal pain treated with anti-inflammatory and rest  referred persistent inguinal pain partially responsive to analgesics with subsequent delay in returning to sport activity; meanwhile, 187 patients 94.4%) started full physical activity after 4 weeks (range 3–6)  of the 11 aforementioned patients referred symptom benefit after conservative treatment with return to sport activity after 12 weeks (range 10–16). The remaining 6 patients (3.0%) referred inguinal pain not responsive to analgesics with inguinal US negative for hernia recurrence. Those patients were treated conservatively with 3 months follow-up. One patient (0.5%) returned to sport activity after 6 months, 2 patients (1.0%) after 9 months while the remaining 3 patients (1.5%) referred persistent local pain after 12 months follow-up and inability to return to professional sport activity.In our series, return to full sport activity was 94.4% (187 patients) at 4 weeks and 98.5% (195 patients) at 12 months. Only 3 patients (1.5%) were unable to return to elite sport activity because of non-responsive chronic inguinal pain.One patient (0.5%) returned to our attention after 45 months from surgery referring monolateral pain; both clinical examination and inguinal US were negative for disease recurrence. The patient was treated conservatively with sport activity pause for 3 months with complete symptom remission and full return to professional sport activity.Furthermore, in a long-term follow-up, we reported 5 cases (2.5%) of ID recurrence in previously asymptomatic patients: 1 patient (0.5%) after 13 months was treated with conservative therapy; 2 patients (1.0%) after 23 and 29 months were treated with open surgical approach; 1 patient (0.5%) after 48 months was treated with open surgical approach; 1 patient (0.5%) after 60 months was not submitted to surgical treatment because of the patient’s will to stop professional sport activity. All patients with recurrence had inguinal monolateral pain associated to a small groin tumescence. All patients referred recurrence after full return to professional sport activity. At clinical examination, monolateral hernia was diagnosed. Surgical treatment with an open approach (Lichtenstein technique) was performed in 3 patients. Return to full sport activity was possible after 13 weeks from surgery.The Manchester Consensus Conference of the British Hernia Society (BHS)  aimed toFurthermore, Ekstrand et al. showed, in a randomized controlled trial (RCT) including 66 soccer players, that only surgical treatment (open approach) was associated to significant symptom improvement compared to conservative treatment  . AdditioThis study supports the results of the two RCT that are mentioned above , 20, andThe primary aim in ID is to improve the symptoms and enable a fast return to sport activity. Surgery, regardless of open or laparoscopic approach, is considered quite effective for fast return to sport activity . HoweverFurthermore, patients submitted to open approach require to be relatively inactive for the initial four postoperative weeks . TherefoAlthough the surgical site depends on the reported symptoms and diagnosis of ID , 16, 22,P < 0.001), [Post-surgical inguinal pain is the most frequent complication associated to inguinal hernia repair. Several improvements in anatomic knowledge, adoption of “tension free” techniques and the use of lightweight mesh are associated to reduced post-surgical pain . In part 0.001), . We perfIn this study, the main complication was post-surgical pain as described in literature. At 4 weeks, 11 patients (5.6%) referred chronic inguinal pain with delayed return to sport activity. These 11 patients were submitted to medical treatment and physiotherapy. Chronic inguinal pain resolution and return to sport activity was reported by 5 patients after 3 months, 1 after 6 months and 2 after 9 months. Only 3 patients (1.5%) were unable to return to elite sport activity because of non-responsive chronic inguinal pain. In addition, in a long-term follow-up of 13 years, we reported a total of 5 cases (2.5%) of ID recurrence in previously asymptomatic patients.Since this is a retrospective study, it was not possible to characterize the temporal dynamics of postoperative pain intensity and this could be considered a limitation of this study. All the pain symptoms were retrieved by analysing past clinical reports and contacting patients at the time of the study. Furthermore, the first 15 patients of this series were not submitted to a preoperative dUS due to a not fully standardized diagnostic and treatment protocol for ID. This could be considered another possible limitation of this study.Despite the fact of being retrospective, this study could give important details further confirming previously published data in literature. This study evaluates a wide surgical period (13 years) with a long-term follow-up. Moreover, all cases have been highly standardized by performing high-quality ultrasound preoperative evaluation and a standardized surgical procedure in a single surgeon setting.To our knowledge, this series is the widest described single operator TAPP experience in ID in literature. We further demonstrate the efficacy and safety of TAPP technique in ID treatment.ID is a chronic groin pain affecting mainly athletes characterized a multifactorial pathogenesis. Diagnosis of ID is a clinical challenge, and it is frequently associated to secondary or tertiary clinical conditions. Clinical evaluation is fundamental for diagnosis; however, dUS and MRI are useful for achieving a precise diagnosis. The British Hernia Society has proposed diagnostic criteria and a therapeutical algorithm in which surgery is the treatment of choice when conservative treatment fails. Surgical treatment can be either open or laparoscopic. The TAPP approach is safe and effective for the treatment of ID, and it is associated to a faster return to full sport activity. Chronic groin pain is the most frequent post-surgical complication, and it affects a full recovery with delay of sport activity. Our case series is compliant to literature results. To our knowledge, our series is the widest described single operator TAPP experience in ID in literature.