Trial sequential analysis: plain and simple

De Cassai Alessandro,Pasin Laura,Boscolo Annalisa,Salvagno Michele,Navalesi Paolo 대한마취통증의학회 2021 Korean Journal of Anesthesiology Vol.74 No.4

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Explanation of trial sequential analysis: using a post-hoc analysis of meta-analyses published in Korean Journal of Anesthesiology

De Cassai Alessandro,Tassone Martina,Geraldini Federico,Sergi Massimo,Sella Nicolò,Boscolo Annalisa,Munari Marina 대한마취통증의학회 2021 Korean Journal of Anesthesiology Vol.74 No.5

Background: Trial sequential analysis (TSA) is a recent cumulative meta-analysis method used to weigh type I and II errors and to estimate when the effect is large enough to be unaffected by further studies. The aim of this study was to illustrate possible TSA scenarios and their significance using meta-analyses published in the Korean Journal of Anesthesiology (KJA) as working material. Methods: We performed a systematic medical literature search for meta-analyses published in the KJA. TSA was performed on each main outcome, estimating the required sample size on the calculated effect size for the intervention, considering a type I error of 5% and a power of 90% or 99%. Results: Six meta-analyses with a total of ten main outcomes were included in the analysis. Seven TSAs confirmed the results of the meta-analyses. However, only three of them reached the required sample size. In the two TSAs, the cumulative z-lines were not statistically significant. One TSA boundary for effect was reached with the 90% analysis, but not with the 99% analysis. Conclusions: In TSA, a meta-analysis pooled effect may be established to assess if the cumulative sample size is large enough. TSA can be used to add strength to the conclusions of meta-analyses; however, pre-registration of the TSA protocol is of paramount importance. This study could be useful to better understand the use of TSA as an additional statistical tool to improve meta-analysis quality.

Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis

De Cassai Alessandro,Sella Nicolò,Geraldini Federico,Tulgar Serkan,Ahiskalioglu Ali,Dost Burhan,Manfrin Silvia,Karapinar Yunus Emre,Paganini Greta,Beldagli Muzeyyen,Luoni Vittoria,Ordulu Busra Burcu K 대한마취통증의학회 2023 Korean Journal of Anesthesiology Vol.76 No.1

Background: Different regional anesthesia (RA) techniques have been used for laparoscopic cholecystectomy (LC), but there is no consensus on their comparative effectiveness. Our objective was to evaluate the effect of RA techniques on patients undergoing LC using a network meta-analysis approach.Methods: We conducted a systematic review and network meta-analysis. We searched PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and Web of Science (Science and Social Science Citation Index) using the following PICOS criteria: (P) adult patients undergoing LC; (I) any RA single-shot technique with injection of local anesthetics; (C) placebo or no intervention; (O) postoperative opioid consumption expressed as morphine milligram equivalents (MME), rest pain at 12 h and 24 h post-operation, postoperative nausea and vomiting (PONV), length of stay; and (S) randomized controlled trials.Results: A total of 84 studies were included. With the exception of the rectus sheath block (P = 0.301), the RA techniques were superior to placebo at reducing opioid consumption. Regarding postoperative pain, the transversus abdominis plane (TAP) block (−1.80 on an 11-point pain scale) and erector spinae plane (ESP) block (−1.33 on an 11-point pain scale) were the most effective at 12 and 24 h. The TAP block was also associated with the greatest reduction in PONV.Conclusions: RA techniques are effective at reducing intraoperative opioid use, postoperative pain, and PONV in patients undergoing LC. Patients benefit the most from the bilateral paravertebral, ESP, quadratus lumborum, and TAP blocks.

Preoperative dexmedetomidine and intraoperative bradycardia in laparoscopic cholecystectomy: a meta-analysis with trial sequential analysis

De Cassai Alessandro,Sella Nicolò,Geraldini Federico,Zarantonello Francesco,Pettenuzzo Tommaso,Pasin Laura,Iuzzolino Margherita,Rossini Nicolò,Pesenti Elisa,Zecchino Giovanni,Munari Marina,Navalesi Pa 대한마취통증의학회 2022 Korean Journal of Anesthesiology Vol.75 No.3

Background: While laparoscopic surgical procedures have various advantages over traditional open techniques, artificial pneumoperitoneum is associated with severe bradycardia and cardiac arrest. Dexmedetomidine, an imidazole derivative that selectively binds to α2-receptors and has sedative and analgesic properties, can cause hypotension and bradycardia. Our primary aim was to assess the association between dexmedetomidine use and intraoperative bradycardia during laparoscopic cholecystectomy. Methods: We performed a systematic review with a meta-analysis and trial sequential analysis using the following PICOS: adult patients undergoing endotracheal intubation for laparoscopic cholecystectomy (P); intravenous dexmedetomidine before tracheal intubation (I); no intervention or placebo administration (C); intraoperative bradycardia (primary outcome), intraoperative hypotension, hemodynamics at intubation (systolic blood pressure, mean arterial pressure, heart rate), dose needed for induction of anesthesia, total anesthesia requirements (both hypnotics and opioids) throughout the procedure, and percentage of patients requiring postoperative analgesics and experiencing postoperative nausea and vomiting and/or shivering (O); randomized controlled trials (S). Results: Fifteen studies were included in the meta-analysis (980 patients). Compared to patients that did not receive dexmedetomidine, those who did had a higher risk of developing intraoperative bradycardia (RR: 2.81, 95% CI [1.34, 5.91]) and hypotension (1.66 [0.92,2.98]); however, they required a lower dose of intraoperative anesthetics and had a lower incidence of postoperative nausea and vomiting. In the trial sequential analysis for bradycardia, the cumulative z-score crossed the monitoring boundary for harm at the tenth trial.Conclusions: Patients undergoing laparoscopic cholecystectomy who receive dexmedetomidine during tracheal intubation are more likely to develop intraoperative bradycardia and hypotension.

PECS II block is associated with lower incidence of chronic pain after breast surgery

De Cassai, Alessandro,Bonanno, Claudio,Sandei, Ludovica,Finozzi, Francesco,Carron, Michele,Marchet, Alberto The Korean Pain Society 2019 The Korean Journal of Pain Vol.32 No.4

Background: Breast cancer is complicated by a high incidence of chronic postoperative pain (25%-60%). Regional anesthesia might play an important role in lowering the incidence of chronic pain; however it is not known if the pectoral nerve block (PECS block), which is commonly used for breast surgery, is able to prevent this complication. Our main objective was therefore to detect any association between the PECS block and chronic pain at 3, 6, 9, and 12 months in patients undergoing breast surgery. Methods: We conducted a prospective, monocentric, observational study. We enrolled 140 consecutive patients undergoing breast surgery and divided them in patients receiving a PECS block and general anesthesia (PECS group) and patients receiving only general anesthesia (GA group). Then we considered both intraoperative variables (intravenous opioids administration), postoperative data (pain suffered by the patients during the first 24 postoperative hours and the need for additional analgesic administration) and development and persistence of chronic pain (at 3, 6, 9, and 12 mo). Results: The PECS group had a lower incidence of chronic pain at 3 months (14.9% vs. 31.8%, P = 0.039), needed less intraoperative opioids (fentanyl $1.61{\mu}g/kg/hr$ vs. $3.3{\mu}g/kg/hr$, P < 0.001) and had less postoperative pain (3 vs. 4, P = 0.017). Conclusions: The PECS block might play an important role in lowering incidence of chronic pain, but further studies are needed.

Assignment of ASA-physical status relates to anesthesiologists’ experience: a survey-based national-study

Alessandro De Cassai,Annalisa Boscolo,Tommaso Tonetti,Irina Ban,Carlo Ori 대한마취통증의학회 2019 Korean Journal of Anesthesiology Vol.72 No.1

Background: The American Society of Anesthesiologists physical status (ASA-PS) is a grading system adopted worldwide by anesthesiologists to classify the overall health status of patients. Its importance is demonstrated not only by its routine use in clinical practice, but also by its deployment in other healthcare-related environments. However, a weak/ moderate inter-rater reliability for ASA-PS has been previously shown, and although definitions and clinical examples of each class are provided by ASA, doubts remain on the individual factors influencing assignment to an ASA-PS class. The aim of this study was to investigate whether and how an anesthesiologist’s experience affects classification into a specific ASA-PS class. Methods: An online survey presenting eight fictitious patients was administered to a group of Italian anesthesiologists and residents. Respondents were asked to assign each of the eight patients to a specific ASA-PS class. Anesthesiologists were subdivided into five classes according to years of experience as an anesthesiologist. Results: Six hundred one surveys were correctly completed. The highest mean number of correct answers was obtained by residents (3.95 ± 1.13), with the number decreasing progressively with increasing work experience. The lowest value was recorded in the most experienced group (3.13 ± 1.25). Inter-rater reliability was weak/moderate in all experience level groups (k = 0.38). Conclusions: Low inter-reliability of the ASA-PS and the experience-dependence of the anesthesiologist in assigning classifications must be taken into account when evaluating a patient, particularly in settings where wide differences in experience are present.

A brief introduction to Propensity Score for anesthesiologists

Alessandro De Cassai,Giulio Andreatta,Annalisa Boscolo,Marina Munari,Paolo Navalesi 대한마취통증의학회 2020 Korean Journal of Anesthesiology Vol.73 No.4

Intergroup comparability is of paramount importance in clinical research since it is impossible to draw conclusions on a treatment if populations with different characteristics are compared. While an adequate randomization process in randomized controlled trials (RCTs) ensures a balanced distribution of subjects between groups, the distribution in observational prospective and retrospective studies may be influenced by many confounders. Propensity score (PS) is a statistical technique that was developed more than 30 years ago with the purpose of estimating the probability to be assigned to a group. Once evaluated, the PS could be used to adjust and balance the groups using different methods such as matching, stratification, covariate adjustment, and weighting. The validity of PS is strictly related to the confounders used in the model, and confounders that are either not identified or not available will produce biases in the results. RCTs will therefore continue to provide the highest quality of evidence, but PS allows fine adjustments on otherwise unbalanced groups, which will increase the strength and quality of observational studies.

SBP block: further considerations

Alessandro De Cassai,Christelle Correale 대한마취통증의학회 2019 Korean Journal of Anesthesiology Vol.72 No.4

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PECS II block is associated with lower incidence of chronic pain after breast surgery

Alessandro De Cassai,Claudio Bonanno,Ludovica Sandei,Francesco Finozzi,Michele Carron,Alberto Marchet 대한통증학회 2019 The Korean Journal of Pain Vol.32 No.4

Background: Breast cancer is complicated by a high incidence of chronic postoperative pain (25%-60%). Regional anesthesia might play an important role in lowering the incidence of chronic pain; however it is not known if the pectoral nerve block (PECS block), which is commonly used for breast surgery, is able to prevent this complication. Our main objective was therefore to detect any association between the PECS block and chronic pain at 3, 6, 9, and 12 months in patients undergoing breast surgery. Methods: We conducted a prospective, monocentric, observational study. We enrolled 140 consecutive patients undergoing breast surgery and divided them in patients receiving a PECS block and general anesthesia (PECS group) and patients receiving only general anesthesia (GA group). Then we considered both intraoperative variables (intravenous opioids administration), postoperative data (pain suffered by the patients during the first 24 postoperative hours and the need for additional analgesic administration) and development and persistence of chronic pain (at 3, 6, 9, and 12 mo). Results: The PECS group had a lower incidence of chronic pain at 3 months (14.9% vs. 31.8%, P = 0.039), needed less intraoperative opioids (fentanyl 1.61 μg/kg/hr vs. 3.3 μg/kg/hr, P < 0.001) and had less postoperative pain (3 vs. 4, P = 0.017). Conclusions: The PECS block might play an important role in lowering incidence of chronic pain, but further studies are needed.

Erector spinae plane block combined with a novel technique for selective brachial plexus block in breast cancer surgery -a case report-

Alessandro De Cassai,Daniele Bonvicini,Michele Ruol,Christelle Correale,Maurizio Furnar 대한마취통증의학회 2019 Korean Journal of Anesthesiology Vol.72 No.3

Background: The breast is innervated by the intercostal nerves and the brachial plexus. We propose a technique to perform breast surgery without general anesthesia using the erector spinae plane (ESP) block and selective block of four nerves that arise from the brachial plexus innervate the breast and the axilla (SBP block). Case: A 77-year-old man with breast cancer was scheduled for radical mastectomy and axillary clearance. He had a previous history of myocardial infarction with dilated cardiomyopathy and severely impaired ejection fraction. The surgery was performed under regional anesthesia with combined ESP and SBP block. The patient did not require opioids or other supplemental analgesics intra- or postoperatively and was discharged uneventfully. Conclusions: SBP is a novel block that selectively blocks branches of the brachial plexus that innervate the breast.