Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.

OBJECTIVE: The aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to lidocaine (CLIFE2), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment. METHODS: A multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n = 60) or CLIFE2 (n = 60) anorectal topical treatment, and after every 12 h for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days. RESULTS: The results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47 ± 13.09) greater than with CLIFE2 (4.38 ± 6.75), difference -3.21 95% CI (-5.75; -0.68), p = 0.008, decreasing significantly postoperative pain ( ≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine. CONCLUSIONS: The CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.

Study of hyperglycemia in non critically-ill patients receiving parenteral nutrition; incidence and risk factors / Estudio de hiperglicemia en pacientes no críticos tratados con nutrición parenteral; incidencia y factores de riesgo

Background: The objectives of our study on non-critically ill patients receiving parenteral nutrition (PN) are to assess the incidence of hyperglycemia, the risk factors associated to its development and its influence in patient's evolution. Methods: A multicentric prospective observational study was performed in 9 hospitals. Four multivariate studies were developed to study the temporal risk in the occurrence of hyperglycemia (endpoint), intensive care unit (ICU) admission, length of stay (LOS) and death. Demographics, nutrients, drugs and clinical variables were collected. Independent variables studied as a possible risk factors were: sex, diabetes mellitus 2, baseline glycemia, albuminemia, pancreatitis, surgery in the 7 days prior to the end point, infection, insulin/somatostatin/corticoids administration during the study, glomerular filtration rate (GFR), and difference in the amount of glucose administration between the endpoint and one day before. Results: 119 patients were enrolled in the study, 25 cases of hyperglycemia were detected. In the clinical factors associated with PN hyperglycemia, significant variables were: surgery in the 7 days before the end point, GFR, glucose load in the 24 hours previous to the end point insulin administration and somatostatine/octreotide (AU)

Antecedentes y objetivo: El estudio está dirigido a pacientes no críticos tratados con nutrición parenteral (NP) y tiene como objetivo evaluar la incidencia de hiperglucemia, los factores de riesgo asociados a su aparición y su influencia sobre su evolución clínica. Métodos: Estudio multicéntrico prospectivo y observacional en 9 hospitales. Se construyeron 4 modelos multivariantes para estudiar el riesgo de aparición de hiperglucemia (evento final), el ingreso en cuidados intensivos (UCI), el tiempo de hospitalización y muerte. Se recogieron variables demográficas, de nutrientes aportados, medicación y variables clínicas. La variables independientes estudiadas como posibles factores de riesgo fueron: sexo, diabetes mellitus tipo 2, glucemia basal, pancreatitis, cirugía en los 7 días previos al evento final, infección, administración durante el estudio de insulina/somatostatina/corticoides, nivel de filtración glomerular (GFR) y las diferencias entre el aporte de glucosa administrada entre el evento final y el día previo. Resultados: Se incluyeron 119 pacientes, de los cuales 25 presentaron hiperglucemia. Entre los factores clínicos asociados a la aparición de hiperglucemia, las variables significativas fueron: la cirugía en los 7 días previos al evento final, GFR, carga de glucosa en las 24 horas previas al evento final, administración de insulina y de somatostatina/octreotido. La hiperglucemia se asoció significativamente al ingreso en UCI y a la estancia hospitalaria. Conclusión: La administración de glucosa en pacientes no críticos en tratamiento con NP debería ser reevaluada con criterios restrictivos, especialmente en el postoperatorio inmediato, en insuficiencia renal y en pacientes tratados con análogos de la somatostatina. Debería tenerse en cuenta que los incrementos del aporte de glucosa se asocian a hiperglucemia, y esta se correlaciona con un incremento de la estancia hospitalaria y a una mayor frecuencia de ingresos en UCI (AU)

Study of hyperglycemia in non critically-ill patients receiving parenteral nutrition: incidence and risk factors.

BACKGROUND: The objectives of our study on non-critically ill patients receiving parenteral nutrition (PN) are to assess the incidence of hyperglycemia, the risk factors associated to its development and its influence in patient's evolution. METHODS: A multicentric prospective observational study was performed in 9 hospitals. Four multivariate studies were developed to study the temporal risk in the occurrence of hyperglycemia (endpoint), intensive care unit (ICU) admission, length of stay (LOS) and death. Demographics, nutrients, drugs and clinical variables were collected. Independent variables studied as a possible risk factors were: sex, diabetes mellitus 2, baseline glycemia, albuminemia, pancreatitis, surgery in the 7 days prior to the end point, infection, insulin/somatostatin/corticoids administration during the study, glomerular filtration rate (GFR), and difference in the amount of glucose administration between the endpoint and one day before. RESULTS: 119 patients were enrolled in the study, 25 cases of hyperglycemia were detected. In the clinical factors associated with PN hyperglycemia, significant variables were: surgery in the 7 days before the end point, GFR, glucose load in the 24 hours previous to the end point insulin administration and somatostatine/octreotide administration during the study. Hyperglycemia was significantly associated with ICU admission and increased LOS. CONCLUSIONS: Glucose administration in non-critically ill patients receiving PN should be reassessed downwards, especially in the immediate postsurgery, renal impairment and in patients treated with somatostatin analogues. It should be taken into account that an increase in glucose dose may lead to hyperglycemia in these patients and hyperglycemia correlates with longer hospital stay and increased frequency of ICU admissions.