The comparison of effectiveness of two variants of preventive anesthesia/analgesia in cancer surgery

Despite modern drugs and technologies in medicine, the questions of adequate analgesia in the postoperative period remain quite relevant. The effectiveness of preventive analgesia in the perioperative period remains a contentious issue. The study included 53 oncosurgical patients. Gr.1 received dexketoprofen in combination with paracetamol for perioperative analgesia before the operation, Gr.2 the same medication was given before closing the operating wound. Anesthesia in both groups included an inhaled (Sevoran) and an extended epidural. The study showed that the pain intensity on ANI monitoring and the total dose of fentanyl was less in Gr.1, compared to Gr.2. Cortisol plasma level and the level of glycemia in the perioperative period were less in patients in Gr.1 than in Gr.2. Pain intensity after surgery during first postoperative day was lower in Gr.1, then in Gr.2. The administration of multimodal analgesia with paracetamol and dexketoprofen prior to the surgical interventions provides for the best quality of perioperative analgesia in oncological surgical interventions

Неадекватный эпидуральный блок при обезболивании родов и возможности его предупреждения

Предполагается, что дизайн эпидурального катетера может влиять на качество обезболивания. Было проведено сравнение двух видов эпидуральных катетеров – с тремя и с шестью боковыми перфорационными отверстиями на конце – на частоту развития неполного блока. Материалы и методы. В исследование было включено 308 беременных женщин, которым выполнено эпидуральное обезболивание родов. В группу А (Гр. А) включено 271 роженица, у которых был использован эпидуральный катетер с тремя боковыми отверстиями, а в группу В (Гр. В.) включено 50 рожениц, у которых для эпидуральной аналгезии использовали катетер с шестью боковыми отверстиями. Проводилась оценка частоты развития неполного сенсорного блока в правой или левой половине тела. Результаты исследования. Было установлено, что частота развития неполного эпидурального блока у пациенток Гр. А составила 31,4 % (n = 81), а в Гр. В – 6 % (n = 3), р = 0,001. Не было выявлено статистически значимой корреляционной связи возраста, веса, роста и индекса массы тела с частотой развития неполного эпидурального блока. При развитии неполного эпидурального блока частота кесарева сечения не различалась между группами. Выводы. Использование эпидурального катетера с шестью боковыми отверстиями на конце способствует снижению частоты развития неполного блока при эпидуральной аналгезии родов. Ключевы

Імунна відповідь при використанні раннього парентерального харчування та епідуральної анестезії/ аналгезії в структурі періопераційної інтенсивної терапії у хворих на рак сечового міхура в запущеній стадії

Тенденція до зростання рівня захворюваності на рак, що спостерігається як в Україні, так і у світі, і, відповідно, збільшення складності й тривалості оперативних втручань спонукають до пошуку нових і вдосконалення вже існуючих тактик періопераційної допомоги в онкохірургії. Метою нашого дослідження було вивчення взаємозв’язку між вибором анестезіологічного забезпечення, нутритивним статусом хворих на місцевий поширений метастатичний рак сечового міхура та змінами деяких імунологічних показників у ранньому післяопераційному періоді. Матеріали, методи та результати. Проспективне дослідження було проведено на базі відділення анестезіології та інтенсивної терапії Національного інституту раку (м. Київ). Дослідженням було охоплено 46 пацієнтів, прооперованих під загальним інгаляційним наркозом севофлураном у поєднанні з внутрішньовенним фентанілом (у дозі 2–3 мкг/кг), розподілених на дві групи. Пацієнтам 1-ї групи виконували також епідуральну аналгезію, а в ранньому післяопераційному періоді (з першої доби) призначали парентеральне харчування трикомпонентною сумішшю (білки, вуглеводи, жирові емульсії) в перерахунку 25 ккал/кг маси тіла на добу. Було досліджено популяційний та субпопуляційний склад лімфоцитів периферичної крові на підставі визначення фенотипічних характеристик лімфоцитів, яке включало визначення експресії маркерів клітинної приналежності: СD3+, СD20+, CD3+4+, CD3+8+,CD3–16+56+, HLA-DR+. У результаті проведеного дослідження показано, що у хворих на рак сечового міхура (РСМ) застосування епідуральної анестезії й аналгезії та раннього парентерального харчування сприяє збереженню кількості основних ефекторів клітинно-опосередкованої імунної відповіді, а саме: НК-лімфоцитів та ЦТЛ. Беручи до уваги те, що саме клітинна ланка імунної системи відіграє основну роль в реалізації протипухлинної імунної відповіді, забезпечуючи загальну протипухлинну резистентність організму, видається перспективним використання епідурального блоку в оперованих, хворих на запущений рак сечового міхура. Висновки. Використання епідурального блоку в поєднанні з загальною анестезією при проведенні радикальної цистектомії та ранній початок парентерального харчування сприяє меншому навантаженню на імунний стан хворого, зменшенню ускладнень у післяопераційному періоді, ранньому збереженню нутритивного стану та зменшенню тривалості лікування хворих на РСМ у запущеній стадії

Ethical procedures and patient consent differ in Europe

BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 €. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION: There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved

Chronic postsurgical pain in Europe: An observational study

BACKGROUND Chronic postsurgical pain (CPSP) is an important clinical problem. Prospective studies of the incidence, characteristics and risk factors of CPSP are needed. OBJECTIVES The objective of this study is to evaluate the incidence and risk factors of CPSP. DESIGN A multicentre, prospective, observational trial. SETTING Twenty-one hospitals in 11 European countries. PATIENTS Three thousand one hundred and twenty patients undergoing surgery and enrolled in the European registry PAIN OUT. MAIN OUTCOME MEASURES Pain-related outcome was evaluated on the first postoperative day (D1) using a standardised pain outcome questionnaire. Review at 6 and 12 months via e-mail or telephonic interview used the Brief Pain Inventory (BPI) and the DN4 (Douleur Neuropathique four questions). Primary endpoint was the incidence of moderate to severe CPSP (numeric rating scale, NRS ≥3/10) at 12 months. RESULTS For 1044 and 889 patients, complete data were available at 6 and 12 months. At 12 months, the incidence of moderate to severe CPSP was 11.8% (95% CI 9.7 to 13.9) and of severe pain (NRS ≥6) 2.2% (95% CI 1.2 to 3.3). Signs of neuropathic pain were recorded in 35.4% (95% CI 23.9 to 48.3) and 57.1% (95% CI 30.7 to 83.4) of patients with moderate and severe CPSP, respectively. Functional impairment (BPI) at 6 and 12 months increased with the severity of CPSP (P<0.01) and presence of neuropathic characteristics (P<0.001). Multivariate analysis identified orthopaedic surgery, preoperative chronic pain and percentage of time in severe pain on D1 as risk factors. A 10% increase in percentage of time in severe pain was associated with a 30% increase of CPSP incidence at 12 months. CONCLUSION The collection of data on CPSP was feasible within the European registry PAIN OUT. The incidence of moderate to severe CPSP at 12 months was 11.8%. Functional impairment was associated with CPSP severity and neuropathic characteristics. Risk factors for CPSP in the present study were chronic preoperative pain, orthopaedic surgery and percentage of time in severe pain on D1. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01467102

Ethical procedures and patient consent differ in Europe

BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 €. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION: There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P &lt; 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)