Development and validation of the Ex-Care BR model: a multicentre initiative for identifying Brazilian surgical patients at risk of 30-day in-hospital mortality.

BACKGROUND: Surgical risk stratification is crucial for enhancing perioperative assistance and allocating resources efficiently. However, existing models may not capture the complexity of surgical care in Brazil. Using data from various healthcare settings nationwide, we developed a new risk model for 30-day in-hospital mortality (the Ex-Care BR model). METHODS: A retrospective cohort study was conducted in 10 hospitals from different geographic regions in Brazil. Data were analysed using multilevel logistic regression models. Model performance was assessed using the area under the receiver operating characteristic curve (AUROC), Brier score, and calibration plots. Derivation and validation cohorts were randomly assigned. RESULTS: A total of 107,372 patients were included, and 30-day in-hospital mortality was 2.1% (n=2261). The final risk model comprised four predictors related to the patient and surgery (age, ASA physical status classification, surgical urgency, and surgical size), and the random effect related to hospitals. The model showed excellent discrimination (AUROC=0.93, 95% confidence interval [CI], 0.93-0.94), calibration, and overall performance (Brier score=0.017) in the derivation cohort (n=75,094). Similar results were observed in the validation cohort (n=32,278) (AUROC=0.93, 95% CI, 0.92-0.93). CONCLUSIONS: The Ex-Care BR is the first model to consider regional and organisational peculiarities of the Brazilian surgical scene, in addition to patient and surgical factors. It is particularly useful for identifying high-risk surgical patients in situations demanding efficient allocation of limited resources. However, a thorough exploration of mortality variations among hospitals is essential for a comprehensive understanding of risk. CLINICAL TRIAL REGISTRATION: NCT05796024.

Translation, cross-cultural adaptation, and validation of the 10-item spine functional index (SFI-10) in the Brazilians with musculoskeletal spine disorders.

PURPOSE: To translate and cross-culturally adapt the Spine Functional Index (SFI) into Brazilian Portuguese (SFI-Br) in individuals with musculoskeletal spine disorders. METHODS: Participants (n=194) answered the Numerical Pain Rating Scale (NPRS), 36-item Short-Form Health Survey (SF-36), Roland-Morris Disability Questionnaire for General Pain (RMDQ-g), and SFI-25 incorporating the SFI-10. Structural validity, from confirmatory factor analysis (CFA), used comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and chi-square/degrees of freedom (DF). The best structure was considered from the lower values of the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Construct and criterion validity used Spearman's correlation coefficient (rho). Internal consistency used Cronbach's alpha, reliability used intraclass correlation coefficient (ICC2,1), with ceiling and floor effects determined. Error used the standard error of the measurement (SEM) and minimal detectable change, 90% level (MDC90). RESULTS: Adequate fit indices demonstrated an unequivocal one-factor structure only for the SFI-10 (chi-square/DF <3.00, CFI and TLI >0.90, RMSEA <0.08). The SFI-10-Br correlation was high with the SFI-Br (rho=0.914, p<0.001), moderate for the RMDQ-g (rho=-0.78), SF-36 functional capacity domain (rho=0.718) and NPRS (rho=-0.526); and adequate for the remaining SF-36 domains (rho>0.30). Test-retest reliability (ICC2,1=0.826) and internal consistency (alpha=0.864) were high. No ceiling or floor effects were observed, and error was satisfactory (SEM=9.08%, MDC90=25.15%). CONCLUSION: The SFI Brazilian version was successfully produced with the 10-item version showing an unequivocal one-factor structure, high construct and criterion validity, reliability, internal consistency, and satisfactory error. Further research on responsiveness is required.

Tampa Scale for Kinesiophobia in chronic neck pain patients (TSK-neck): structural and construct validity and reliability in a Brazilian population.

BACKGROUND: To date, there are no studies in the literature that define the internal structure of the Tampa Scale for Kinesiophobia (TSK) in patients with chronic neck pain based on factorial analysis. As such, we aimed to verify and identify the best structure of the Brazilian version of the TSK in patients with chronic neck pain. METHODS: We included Brazilian participants aged ≥18 years, both sexes, with self-reported neck pain for more than 3 months and pain intensity ≥3 on the Numerical Pain Rating Scale (NPRS). Dimensionality and number of TSK items were assessed using confirmatory factor analysis (CFA). We tested the following internal structures: structure 1 (1 domain and 17 items), structure 2 (1 domain and 11 items), structure 3 (2 domains and 11 items), and structure 4 (2 domains and 9 items). We used the Pain-Related Catastrophizing Thoughts Scale (PCTS) and the NPRS for construct validity. In addition, we assessed test-retest reliability for the seven-day interval using intraclass correlation coefficient (ICC2,1), Cronbach's alpha to assess internal consistency, and ceiling and floor effects. RESULTS: The study sample included of 335 patients. Most were women (77.6%), young adults (~ 34 years), single (48.4%), with complete primary education (57.3%), physically inactive (66.6%), with a mean pain duration of 46 months and a mean pain intensity of ~ 5 points on the NPRS. Redundancy was found in the following items: item 1 with item 2 (modification indices = 21.419) and item 13 with item 15 (modification indices = 13.641). Subsequently, based on these paired analyses, the items with the lowest factor loadings (items 2 and 15) were excluded. As such, TSK structure 4 was composed of two domains ("somatic focus" and "activity avoidance") and 9 items, which showed adequate fit indices and lower AIC and SABIC values. We observed significant values (p < 0.05) with a correlation magnitude greater than 0.142 to 0.657 between the two domains of the TSK-neck and the other instruments (PCTS and NPRS). We found excellent reliability (ICC2,1 ≥ 0.96) and adequate internal consistency (Cronbach's alpha ≥0.98) of the TSK-neck. Finally, ceiling and floor effects were not observed. CONCLUSION: The TSK-neck structure with two domains (somatic focus and activity avoidance) and nine items is the most appropriate for patients with chronic neck pain.

Hypertonic glucose in the treatment of low back pain: A randomized clinical trial.

BACKGROUND: Chronic low back pain (LBP) is defined as pain lasting longer than 3 months and is one of the conditions with the most significant social impact. Treatment is complex and includes proliferative agents used in prolotherapy. The mechanism is not known, but osmotic agents (hypertonic solutions of dextrose or glucose) cause cellular rupture and an inflammatory response that releases cytokines and growth factors that lead to scarring and reinnervation. METHODS: Patients with chronic LBP (>12 weeks) who were non-traumatic and unresponsive to at least 1 month of physical therapy were selected. All patients were followed up at a return visit at 1, 3, and 6 months for pain assessment using validated pain questionnaires and scales. RESULTS: Nineteen patients were included in the conservative group and 19 in the glucose group, with the majority being women (57.9%). The patients were between 47 and 59 years of age (39.5%), mixed race (76.33%), married or in a committed relationship (73.7%), and had completed the study for 5.2 years. Overall mean body mass index was 27.3 ± 4.4 kg/m 2 and was higher in the conservative group (28.0 ± 4.7 kg/m 2 ). The groups showed differences in Visual Analog Scale scores, with median and amplitude values close to each other between the time points evaluated and increasing values in the glucose group, which had significantly higher values for this scale at the third evaluation ( P = .031). When comparing the Rolland-Morris scale scores between the groups, there was a significant difference only in the 3-m assessment ( P = .021). In the follow-up assessment, both groups showed significant improvement between T0 and the other assessment time points ( P < .05) in all evaluations. CONCLUSION: Both groups significantly improved on the evaluated scales during follow-up. Overall, no effects were attributable to the glucose components or the prolotherapy protocol.

Barthel Index is a valid and reliable tool to measure the functional independence of cancer patients in palliative care.

BACKGROUND: Our objective was to verify the reliability, internal consistency and construct validity of the Barthel Index in Brazilian cancer patients in palliative care. METHODS: We included patients with cancer, both sexes, and age greater than or equal to 18 years. We used to evaluate patients the Barthel Index, Karnofsky Performance Scale (KPS), and European Organization for Research in the Treatment of Cancer Questionnaire-core 15 (EORTC-QLQ-C15-PAL). The measurement properties evaluated in this study were test-retest and inter-rater reliability and construct validity (tested by means of correlations with other instruments). RESULTS: We included 220 patients for construct validity and a subsample of 27 patients for reliability analyses. We observed adequate reliability (intraclass correlation coefficient ≥ 0.962) and internal consistency (Cronbach's alpha = 0.942). There were adequate correlations between the Barthel Index and the KPS (rho = 0.766), and the functional capacity domain of the EORTC-QLQ-C15-PAL (rho = -0.698). CONCLUSION: The Brazilian version of the Barthel Index presents adequate test-retest and inter-rater reliability, acceptable internal consistency, and valid construct for measuring functional independence in cancer patients.

Comparative Study of Clinical and Ultrasound Parameters for Defining a Difficult Airway in Patients with Obesity.

INTRODUCTION: Patients with obesity have anatomical changes due to increased adipose tissue that negatively affect airway accessibility, making it difficult to establish an advanced airway through orotracheal intubation. This article aims to evaluate the correlation of clinical and sonographic parameters as predictors of difficult airway management (DAM) in patients with obesity and to establish the predictive value of the skin-epiglottis distance as an indicator of a probable DAM. METHODS: This is an observational, prospective study of 100 patients with obesity who underwent bariatric surgery over a 12-month period. The patients were categorized into the easy airway and the difficult airway groups, according to the Cormack-Lehane classification in the laryngoscopy evaluation, and the clinical and sonographic variables collected were statistically evaluated to obtain the relation with the presence of DAM, according to the Cormack-Lehane classification. RESULTS: The mouth opening (p = 0.010) and the skin-epiglottis distance (p = 0.019) were statistically significant when comparing the easy airway and the difficult airway groups of the Cormack-Lehane classification. The predictive value of the skin-epiglottis distance for difficult airway assessment was 29.3 mm. The neck circumference (p = 0.225), the Mallampati index (p = 0.260), and the other clinical variables showed no statistical relevance when compared in isolation with the Cormack-Lehane groups. CONCLUSION: The ultrasound method as a predictor of difficult intubation is promising in anesthetic practice when used according to standardized measurements evaluation and cutoff values.

Oncologic Safety of Autologous Fat Grafting after Breast Cancer Surgical Treatment: A Matched Cohort Study.

BACKGROUND: Autologous fat grafting has been an increasingly popular procedure for remodeling the breast of patients undergoing breast cancer surgery. This study's objective was to investigate whether autologous fat grafting is associated with a higher risk of disease recurrence in the context of late breast reconstruction for patients diagnosed with breast cancer who have undergone either breast-conserving surgery or mastectomy. METHODS: A retrospective matched cohort study was performed in a single tertiary health care center. Data were collected from 42 patients formerly treated for breast cancer who underwent the first session of autologous fat grafting between August of 2007 and June of 2016. A total of 126 patients with similar features, who did not undergo autologous fat grafting, were individually matched at a 1:3 ratio with the autologous fat grafting group. The primary endpoint was locoregional recurrence. Secondary outcomes were rates of local and distant recurrences, disease-free survival, and overall survival. RESULTS: At a mean follow-up of 65 months after fat grafting, no significant differences were found between the lipofilling and control groups for locoregional recurrence (7.1 percent versus 6.3 percent; p = 0.856), local recurrence (7.1 percent versus 5.6 percent; p = 0.705), distant recurrence (14.3 percent versus 7.9 percent; p = 0.238), disease-free survival (21.4 percent versus 19.0 percent; p = 0.837), and overall survival (14.3 percent versus 7.1 percent; p = 0.181). CONCLUSIONS: No evidence of increased risk in any of the survival outcomes was identified. Lipofilling seems to be a safe procedure for breast reconstruction after surgical treatment of breast cancer. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Minimum Effective Analgesic Concentration of Ropivacaine in Saphenous Block Guided by Ultrasound for Knee Arthroscopic Meniscectomy: Randomized, Double-Blind Study.

BACKGROUND: After knee surgery, analgesia should be effective for mobilization and discharge. AIM OF THE STUDY: The primary objective of this study was to achieve the lowest effective analgesic concentration (MEC50 and MEC90) of ropivacaine for saphenous nerve block in arthroscopic meniscectomy. The secondary objective was to determine whether the block causes muscle weakness in the postoperative period. METHODS: The study was randomized, comparative, and double-blind. Fifty-one patients between 18 and 65 years old of both sexes, ASA I or II, who underwent knee arthroscopic meniscectomy at São Domingos Hospital were included. Patients underwent saphenous nerve block with 10 mL of ropivacaine administered by using the up-and-down method. The ropivacaine concentration was determined based on the previous patient's response (a biased-coin up-down design sequential method). If a patient had a negative response, the concentration of ropivacaine was increased by 0.05% in the next patient; if the response was positive, the next patient was randomized to be administered the same concentration of ropivacaine or a 0.05% lower concentration. Successful block was defined as pain <4 during 6 h. Patients underwent general anesthesia with 30 µg/kg alfentanil and propofol and maintenance with propofol, and, if necessary, remifentanil was administered. Postoperative analgesia was complemented with dipyrone, and if necessary, tramadol (100 mg) could be used. The following parameters were assessed: the success of the block; pain intensity after 2, 4, and 6 h; the consumption of remifentanil; time to the first analgesic supplementation; percent of patients who needed analgesics during 6h; and muscle strength. RESULTS: The MEC50 of ropivacaine was 0.36%, and the MEC90 was 0.477%. The block was successful in 45 patients. CONCLUSION: Saphenous block with 10 mL of 0.36% ropivacaine provides adequate analgesia for outpatient meniscectomy.

Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty.

BACKGROUND AND OBJECTIVES: Opioids are associated with sedation and respiratory depression. The primary objective of this study was to assess pain intensity after gastric bypass with lidocaine. The secondary objective was to assess the IL-6 concentration, consumption of morphine, time to morphine request, time to extubation, and side effects. METHODS: Sixty patients aged 18 to 60 years, with ASA (American Society of Anesthesiologists) scores of 2 or 3, who underwent bariatric surgery were allocated to two groups. Patients in group 1 were administered lidocaine (1.5 mg/kg) 5 min before the induction of anesthesia, and group 2 was administered 0.9% saline solution in an equal volume. Subsequently, lidocaine (2 mg/kg/h) or 0.9% saline was infused during the entire surgical procedure. Anesthesia was performed with fentanyl (5 µg/kg), propofol, rocuronium, and sevoflurane. Postoperative patient-controlled analgesia was provided with morphine. The following were evaluated: pain intensity, IL-6, 24-h consumption of morphine, time to the morphine request, time to extubation, and adverse effects. RESULTS: The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation. The lidocaine group consumed less morphine within 24 h, had a longer time until the first supplemental morphine request, and had a lower incidence of nausea. CONCLUSIONS: Lidocaine reduced the intensity of early postoperative pain, incidence of nausea, and consumption of morphine within 24 h and increased time to the first morphine request, without reducing the plasma concentrations of IL-6.

High dose gabapentin does not alter tumor growth in mice but reduces arginase activity and increases superoxide dismutase, IL-6 and MCP-1 levels in Ehrlich ascites.

OBJECTIVES: The purpose of this study was to evaluate the effect of gabapentin on Ehrlich tumor growth in Swiss mice, a highly aggressive and inflammatory tumor model. Mice were grouped into sets of 5 animals and treated from days 2 to 8 with gabapentin 30 mg/kg body weight (G30) or 100 mg/kg body weight (G100), or normal sterile saline (control). RESULTS: The mice were euthanized on day 10. Tumor growth, tumoricidal agents and inflammatory cytokines levels were assessed. At day 10, G30 and G100 mice gained weight, but there were no differences in tumor cell count or in ascites volume. In G100, there was a reduction in arginase and an increase in SOD activities. There was an increase in IL-6 and MCP-1 levels, especially in G100, but no alterations in TNF-α. There was no direct evidence of tumor induction by gabapentin. However, the findings suggest that its use modulates immune response to a more effector and less deleterious profile, with increase in activity of anti-oxidant enzymes and in cytokines that favor activation of macrophages, which could improve the general status of the tumor host.

Tumor growth activity of duloxetine in Ehrlich carcinoma in mice.

OBJECTIVE: The objective of this study was to analyze whether duloxetine influences tumor growth in Ehrlich carcinoma. The mice were administered 5 or 30 mg/kg of duloxetine or saline solution. All animals were inoculated with tumor cells. The tumor progression was evaluated by body weight, abdominal circumference, ascites volume and tumor cell count. The effect of duloxetine on immune response was evaluated by lymphoid cells, nitric oxide (NO) production, arginase and superoxide dismutase (SOD) activity and the spleen immunophenotyping. RESULTS: There was no difference between the groups regarding weight, abdominal circumference, ascites volume and number of tumor cells. Duloxetine increased the cells of the inguinal lymph node. There was no difference in the number of cells in the bone marrow and spleen. Ascites SOD activity was greater in Duloxetine groups. There were no differences in the levels of NO, nitrite, and arginase. The number of antibody for CD3 (CD3+), CD4+, CD8+ and CD28+ cells was lower in the duloxetine groups. In conclusion, duloxetine has no direct effect on tumor growth and does not alter immunity. The drug increased the SOD that fights free radicals and led the migration of lymphocytes, suggesting that duloxetine could be used in tumor-bearing individuals.

Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy.

BACKGROUND AND OBJECTIVES:: Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. DESIGN AND SETTING:: Randomized, prospective and comparative study at Dr. Mário Gatti Hospital. METHODS:: Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG) received local infiltration (0.75% ropivacaine) under general anesthesia; the spinal group (SG) received subarachnoid block (2 ml of 0.5% bupivacaine). Analgesic supplementation consisted of fentanyl for LG and lidocaine for SG. Postoperative pain intensity, sphincter relaxation, lower-limb strength, time to discharge, analgesic dose over one week and adverse effects were assessed. RESULTS:: Eleven LG patients (52.4%) required supplementation, but no SG patients. Pain intensity was higher for LG up to 120 min, but there were no differences at 150 or 180 min. There were no differences in the need for paracetamol or tramadol. Times to first analgesic supplementation and hospital discharge were longer for SG. The adverse effects were nausea, dizziness and urinary retention. CONCLUSIONS:: Pain intensity was higher in LG than in SG over the first 2 h, but without differences after 150 and 180 min. Time to first supplementation was shorter in LG. There were no differences in doses of paracetamol and tramadol, or in adverse effects. REGISTRATION:: ClinicalTrials.gov NCT02839538.

Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy / Estudo clínico randomizado do efeito analgésico da infiltração local versus bloqueio espinal para hemorroidectomia

ABSTRACT BACKGROUND AND OBJECTIVES: Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. DESIGN AND SETTING: Randomized, prospective and comparative study at Dr. Mário Gatti Hospital. METHODS: Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG) received local infiltration (0.75% ropivacaine) under general anesthesia; the spinal group (SG) received subarachnoid block (2 ml of 0.5% bupivacaine). Analgesic supplementation consisted of fentanyl for LG and lidocaine for SG. Postoperative pain intensity, sphincter relaxation, lower-limb strength, time to discharge, analgesic dose over one week and adverse effects were assessed. RESULTS: Eleven LG patients (52.4%) required supplementation, but no SG patients. Pain intensity was higher for LG up to 120 min, but there were no differences at 150 or 180 min. There were no differences in the need for paracetamol or tramadol. Times to first analgesic supplementation and hospital discharge were longer for SG. The adverse effects were nausea, dizziness and urinary retention. CONCLUSIONS: Pain intensity was higher in LG than in SG over the first 2 h, but without differences after 150 and 180 min. Time to first supplementation was shorter in LG. There were no differences in doses of paracetamol and tramadol, or in adverse effects. REGISTRATION: ClinicalTrials.gov NCT02839538.

RESUMO CONTEXTO E OBJETIVO: A analgesia pós-operatória e a recuperação precoce são relevantes para a alta hospitalar. O objetivo primário deste estudo foi comparar a eficácia analgésica da infiltração perianal e da anestesia subaracnóidea para hemorroidectomia. O objetivo secundário foi comparar o tempo para alta, efeitos adversos e complicações. TIPO DE ESTUDO E LOCAL: Estudo randomizado prospectivo e comparativo, no Hospital Dr. Mário Gatti. MÉTODOS: Foram incluídos 40 pacientes com idades 18-60 anos, na categoria 1 ou 2 de status físico da Sociedade Americana de Anestesiologistas. O grupo local (LG) recebeu infiltração local (ropivacaína a 0,75%) sob anestesia geral; o espinal (SG) recebeu bloqueio subaracnóideo (2 ml de bupivacaína a 0,5%). A suplementação analgésica foi com fentanil para LG e lidocaína para SG. Foram avaliados: intensidade da dor no pós-operatório, relaxamento do esfíncter, força dos membros inferiores, tempo de alta, dose de analgésico em uma semana e efeitos adversos. RESULTADOS: Onze (52,4%) pacientes em LG necessitaram de complementação, e nenhum em SG. A intensidade da dor foi maior para LG até 120 minutos, sem diferenças em 150 ou 180 minutos. Não houve diferenças na necessidade de paracetamol ou tramadol. O tempo para a primeira complementação analgésica e a alta hospitalar foram maiores para SG. Os efeitos adversos foram náuseas, tonturas e retenção urinária. CONCLUSÕES: A intensidade da dor foi maior na LG que na SG nas primeiras 2 horas, porém sem diferenças após 150 e 180 minutos. O tempo para a primeira suplementação foi menor na LG; sem diferenças nas doses de paracetamol e tramadol e efeitos adversos. REGISTRO: ClinicalTrials.gov NCT02839538.