Stesura Seveso Archivio Italiano di Urologia e Andrologia 2022; 94, 4396 ORIGINAL PAPER No conflict of interest declared. INTRODUCTION Prostate cancer (PCa) is the most common neoplasm in men and accounts for 27% of all cancers diagnosed (1). In developed countries, population awareness and wide Prostatic Specific Antigen (PSA) screening has resulted in an early on-set detection, with most cases being discov- ered as localized disease and therefore being eligible for definitive therapy, including radical prostatectomy or radiotherapy (2). Surgical excision of the prostate may be carried out either with a retropubic open approach or with the laparoscopic or robot-assisted technique (2). The goal of radical prostatectomy, is eradication of the disease with preservation of continence and erectile func- tions (3). Due to high-costs of acquiring and maintaining robotic equipment, the retropubic open approach is still being practiced alongside newer methods worldwide, providing excellent results in patient survival rates and quality of life (4). In this study we aimed to evaluate two methods of anaes- thesia (general and combined epidural-spinal) in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the onco- logical outcome and safety of the procedure. MATERIALS AND METHODS The study was conducted at the 2nd Urology University Department of Sismanoglio Hospital in Athens Greece, from August 2020 to July 2022, after being approved by the Institutional Review Board of the Hospital. Patients with clinically localized PCa and eligible for Radical Retropubic Prostatectomy (RRP), were preoperative- ly allocated to receive either Combined Epidural and Spinal Anaesthesia (CESA) or General Anaesthesia (GA). All patients were preoperatively informed about both methods of anaesthesia and signed a consent form. Patients with a medical history of severe heart disease, haemostasis disorders, previous pelvic surgery and lung disease were excluded from the study. A Body Mass Index (BMI) value was calculated for all patients, preoperatively, as weight in kg divided by squared height in meters (kg/m2). There are 4 BMI cate- gories Underweight (< 18.5), Normal weight (18.5-24.9), Overweight (25-29.9) and Obesity (> 30). Objective: The aim of this study is to deter- mine if patients undergoing radical retropu- bic prostatectomy with localized prostate cancer under com- bined (epidural-spinal) anaesthesia have any benefit over patients undergoing the procedure under general anaesthesia. Material and Methods: Patients with clinically localised prostate cancer, scheduled for radical retropubic prostatectomy, were allocated to undergo the operation under either general anaes- thesia (GA) or under combined (epidural-spinal) (CESA) anaes- thesia. Several parameters were recorded both preoperatively (medical history, biometric data, PSA, biopsy Gleason score) and postoperatively (blood pressure, heart rate, haemoglobin levels, operation time and total hospital stay). In addition, mean arterial pressure, change in heart rate, total blood loss, blood transfusions, SAS score, intravenous fluid administration and operation time were also noted down intraoperatively. Patient pain levels and total satisfaction were evaluated using appropri- ate questionnaires. At the 12-month follow-up, biochemical recurrence using PSA levels and urinary continence status were evaluated. Results: A total of 60 patients were included (30 in each group). Intraoperatively, mean MAP and heart rate change was higher in the GA group (MAP+7,46, HR+27) and mean SAS was higher in the CESA group (+0.93). The time needed for patients’ recov- ery was faster (-3.5 min) and hospitalization was shorter for patients in the CESA group (-0.6 days). Intraoperative blood loss, time for induction and duration of operation were not sig- nificantly different. Mean postoperative drop of haemoglobin was greater in the GA group (+0.56) while blood transfusions, VAS pain scores and amount of intravenous fluids did not differ significantly between the two groups. No complications were reported. Patient satisfaction and urinary continence were comparable between the groups and there were no cases of biochemical recurrence. Conclusions: Radical retropubic prostatectomy can safely be performed under combined (spinal epidural anaesthesia, with possible benefits of lower blood loss, less post-operative compli- cations and earlier discharge. Both procedures have equal onco- logical and functional outcomes at the 12-month follow-up. KEY WORDS: Prostatic neoplasm; Radical prostatectomy; Complications; Combined anaesthesia. Submitted 12 October 2022; Accepted 31 October 2022 The effects of method of anaesthesia on the safety and effectiveness of Radical Retropubic Prostatectomy Konstantinos Pikramenos 1, Maria Zachou 2, Eleftheria Apostolatou 1, Dimitrios Papadopoulos 3, Maria Mitsogianni 4, Athanasios Papatsoris 1, Ioannis Varkarakis 1, Iraklis Mitsogiannis 1 1 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens, Greece; 2 Gastroenterology Department, Sismanoglio Hospital, Athens Greece; 3 Anaesthesiology Department, Evgenidio Hospital, National and Kapodistrian University of Athens, Greece; 4 4th Department of Medical Oncology, Hygeia Hospital, Athens, Greece. DOI: 10.4081/aiua.2022.4.396 Summary 397Archivio Italiano di Urologia e Andrologia 2022; 94, 4 Anesthesia effects on Radical Prostatectomy Patients in the GA group were premedicated with intra- venously administered (IV) midazolam (2 mg) and fen- tanyl (100 mcg). A simple oxygen mask was applied. Induction was performed using IV propofol (2.5-3 mg/kg) and lidocaine (40 mg); at that time dexametha- sone 8 mg, metoclopramide 10 mg and omeprazole 40 mg were also administered. After successful tracheal intu- bation, Total Intravenous Anaesthesia (TIVA) was main- tained by administering propofol (0.05 mg/kg/sec IV) and remifentanil (0.2 mcg/kg/sec iv). Pain management was achieved by administering paracetamol (1g IV) and ramadol (100 mg iv) whereas muscle relaxation was obtained by vecuronium (0.6 mg/kg IV). CESA group was performed using an epidural 18G nee- dle and a spinal 27G needle, which were inserted in the L2-L3 or L3-L4 interspace. Induction was carried out by spinal intrathecal administration of levobupivacaine (2.6- 3ml of 0.5%) whereas mild sedation was achieved by midazolam (5 mg IV in bolus). All patients were admin- istered dexamethasone 8 mg, metoclopramide 10 mg and omeprazole 40 mg IV, at that time. Maintenance was per- formed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5 ml of 0.5%). An epidural catheter was maintained until suc- cessful completion of the procedure and removed in the recovery room. The medications used for both types of anaesthesia are presented in Table 1. All patients in both groups received a standard postopera- tive regimen of intravenous paracetamol (1 g x 4 for the first 2 days) and cefoxitin (1 g x 3 until discharge); a pro- phylactic dose of enoxaparin was also given subcutaneous- ly for 2 weeks, starting from postoperative day 2. If a patient was experiencing pain that could not be alleviated using the standard analgesic regimen, extra tramadol was administered on demand and recorded by the reviewer. Several parameters were recorded intra- and postoperative- ly. The time (minutes) required for induction of anaesthe- sia, the operation time and the total postoperative time (defined as that required for patients’ recovery, i.e., from completion of the operation to patient transfer to the recov- ery room) were noted down. Intraoperative haemodynam- ic status was constantly being monitored by measuring sys- tolic pressure (SP) and diastolic arterial pressure (DP) and heart rate every 15 minutes; the Mean Arterial Pressure (MAP) was also being calculated using the formula MAP=DP+1/3(SP-DP). Haemoglobin levels, both preopera- tive and at specific times postoperatively (at the 12th, 24th and 48th postoperative hours) were also measured. In addi- tion, total blood loss (litres of fluid collected by suction dur- ing surgery which were categorised in < 100 ml, 100-600 ml and > 1000 ml), fluids administered intravenously dur- ing surgery (in litres) and the Surgical Apgar Score (SAS) (5) were calculated. Postoperatively, total hospitalization days, patient pain intensity using the Visual Analogue Scale (VAS) and any need for extra analgesics were recorded. VAS is based on a linear “zero” (No pain) to “ten” (Worst Pain Possible) scale. Patients were asked to quantify their pain on that scale, at three different postoperative time points (after 6, 24, and 48 hours). Complications from the cardiovascu- lar and respiratory systems as well as those related to the anaesthetic techniques were recorded; in addition, postop- erative headache, nausea and vomiting and any signs of potential nerve damage (manifested as inability to gain leg motility) were also assessed and recorded before hospital discharge (6, 7). All patients upon discharge filled in a Short Assessment of Patient Satisfaction (SAPS) Questionnaire (8) measuring their overall satisfaction for the care they received. In SAPS, satisfaction is measured in a scale of 0 to 28, with 0 to 10 equals to “Very Dissatisfied”, 11-18 equals to “Dissatisfied”, 19-26 equals to “Satisfied” and 27-28 equals to “Very Satisfied”. Patients were followed for up to 12 months postoperative- ly. PSA levels were measured at the 6th and 12th month to record a potential biochemical recurrence. At the same time, patients were asked to assess their urinary continence by completing the International Consultation on Incontinence Questionnaire (9) - Urinary Incontinence Short Form. Statistical analysis was carried out using SPSS 24.0. Mean values, standard deviations, median values, Interquartile Range (IQR) and histograms were used to describe quanti- tative variables whether the data followed the normal dis- tribution. Collected data for systolic blood pressure, dias- tolic blood pressure, heart rate and haemoglobin were used with new quantitative variables being created by calculat- ing the differences between the aforementioned time- points for each one of these variables. The Kolmogorov- Smirnov test was run to check the normality of the distri- butions. The Student's t-test or the non-parametric Mann- Whitney U test were used to compare quantitative variables between the two groups, depending on whether the data followed the normal distribution. A Kruskal-Wallis test (nonparametric equivalent of the one-way ANOVA) was used to make comparisons among the BMI-categories in CESA and GA group. Moreover, linear or logarithmic mod- els were used to check for differences between the studied groups, taking into account other factors (e.g., demo- graphic and clinical characteristics). In case of asymmetri- cal distribution, logarithmic transformations of the vari- ables were used. Significance levels were bilateral and the statistical significance were set at p < 0.05. RESULTS Overall, 60 patients were included in the Study (30 in each group). Both groups were demographically compa- Table 1. Anaesthetic techniques in the study groups. Anaesthesia stage Combined epidural - Spinal anaesthesia General anaesthesia Premedication None Midazolam 2 mg bolus IV Fentanyl 100 mcg bolus IV Induction Levobupivacaine 0.5% 2.6-3cc Spinal intrathecal Lidocaine 40 mg bolus IV Midazolam 5 mg IV Propofol 2,5-3 mg/kg bolus IV Dexamethasone 8 mg IV Dexamethasone 8 mg IV Metoclopramide 10 mg IV Metoclopramide 10 mg IV Omeprazole 40 mg IV Omeprazole 40 mg IV Maintenance Levobupivacaine 0.5% 4-5cc epidural Propofol 0.05 mg/kg/sec IV Remifentanil 0.2 mcg/kg/sec IV Paracetamol 1 g IV Tramadol 100 mg IV Vecuronium 0.6 mg/kg IV Recovery room Paracetamol 1g IV Paracetamol 1g IV IV = Intravenous; mg = Milligram; g = Grams; kg = Kilograms; mcg = Microgram. Archivio Italiano di Urologia e Andrologia 2022; 94, 4 K. Pikramenos, M. Zachou, E. Apostolatou, et al. 398 rable and homogeneous with regard to age, height, weight, smoking habit, alcohol use, history of diabetes mellitus, biopsy Gleason Score and preoperative PSA. Preoperative characteristics are presented in Table 2. Intraoperative MAP was found to be significantly higher in the GA group [85.13 ± 11.84] vs. CESA group [77.67 ± 5.66] (p = 0.036) (Figure 1). Furthermore, patients in the GA group exhibited higher heart rate intraoperatively when compared to the preoperative measurement, as opposed to those in the CESA group who exhibited lower heart rate than the preoperative measurement (GA: +25 (17), CESA: -2 (7), (p < 0.01). Intraoperative blood loss, as collected by the suction, did not differ significantly between the two groups. Time for anaesthesia induction was identical in both groups (13.6 ± 3.5 min in the CESA group vs. 13.6 ± 2.9 min in the GA group, p > 0.05). Duration of the operation in the CESA and GA groups was 127 ± 17.29 min and 126.33 ± 10.93 min, respec- tively (p > 0.05). However, the time needed for patients’ recovery and transfer to the recovery room was signifi- cantly shorter in the CESA group (16.13 ± 4.9 min) as compared to that in the GA group (19.6 ± 3.5) (p = 0.03). Statistically significant difference was also noticed in the mean intraoperative SAS (8.13 ± 0.63 in the CESA group vs. 7.2 ± 1.37 in the GA group, p < 0.03). A SAS score ≤ 6 was recorded in 6 patients (20%) in the GA group in comparison to none in the CESA Group (Figure 2). Hospitalisation was significantly shorter for patients in the CESA group compared to those of the GA group (2.6 ± 0.5 vs. 3.2 ± 0.41, respectively, p = 0.003). Postoperative mean drop of haemoglobin was 1.5 ± 0.81 in the CESA group vs. 2.06 ± 1.1 in the GA group (p = 0.029), indicating a statistically significant difference in blood loss in favour of the combined anaesthesia. Blood transfusion was required in 1 patient in the CESA group and 2 patients in the GA group (p = 0.54). VAS score was found to be equal between the two groups and all patients reported only mild pain 48 hours after the surgery, con- trary to moderate and severe pain reported on the day of surgery and 24 hours after. Data regarding haemoglobin changes and VAS score are listed in Tables 3, 4. Figure 1. MAP values in the CESA and GA groups. Table 2. Demographic and oncological characteristics of patients. Demographics CESA (n = 30) GA (n = 30) 95% CI, p-value Mean ± SD Mean ± SD Age (years) 66.93 ± 5.66 66.40 ± 4.89 (-3.42, 4.49), 0.78 * Height (m) 1.72 ± 0.078 1.75 ± 0.044 (-0.08, 0.01), 0.140 * Weight (kg) 78.8 ± 10.57 81.87 ± 14.96 (-12.75, 6.62), 0.52 * ASA physical status (II/III) 23/7 20/10 NS ** Preoperative PSA (ng/ml) 6.81 ± 3.06 8.01 ± 2.78 (-3.38, 0.99), 0.27 * Gleason Score NS ** 6 6/30 4/30 3+4 10/30 8/30 4+3 8/30 10/30 8 6/30 7/30 9 0/30 1/30 CESA = Combined Epidural and Spinal Anaesthesia; GA = General Anaesthesia; ASA = American Society of Anaesthesiologists; PSA = prostate-specific antigen; NS = non-significant. * Independent samples t-test. ** Pearson Chi-square test. Table 3. Haemoglobin change within the first 48 hours. Hb change CESA group GA group p-value * Mean ± SD Mean ± SD Pre-op/Post-op -2.06 ± 1.1 -1.5 ± 0.81 0.029 24h – after surgery -0.9 ± 0.59 -1.18 ± 0.84 0.305 48h – 24h -0.28 ± 0.73 -0.48 ± 0.71 0.439 48h – after surgery -1.18 ± 0.66 -1.67 ± 0.93 0.113 48h – before surgery -3.24 ± 1.19 -3.18 ± 1.19 0.771 Pre-op: Pre operatively; Post-op: Post operatively. * Independent samples t-test. Table 4. VAS Score within the first 48 hours. VAS CESA group GA group p-value * Day of surgery 6.47 ± 0.51 6.53 ± 0.51 0.720 24h after surgery 5.13 ± 0.51 5 ± 0.53 0.487 48h after surgery 3.2 ± 0.41 3.33 ± 0.48 0.417 SD: standard deviation; CESA: combined epidural spinal anaesthesia; GA: general anaesthesia; VAS: Visual Analog Scale. * Independent samples t-test. CESA = Combined Epidural and Spinal Anaesthesia; GA = General Anaesthesia; SAS = Surgical APGAR score; MAP = Mean Arterial Pressure. Figure 2. SAS scores in the CESA and GA groups. CESA = Combined Epidural and Spinal Anaesthesia; GA = General Anaesthesia; SAS = Surgical APGAR score; MAP = Mean Arterial Pressure. 399Archivio Italiano di Urologia e Andrologia 2022; 94, 4 Anesthesia effects on Radical Prostatectomy No complications were reported across any group and none of the patients in the CESA group reported either post-subarachnoid puncture headache or any nerve dam- age or difficulty in regaining leg motility. In the CESA group, there was no case with a need for the anaesthesia to be dynamically converted to GA during surgery. Additional postoperative analgesic requirements as well as the daily amount of intravenous fluids did not differ significantly between the two groups, (CESA: 2933 ± 703.7 ml daily vs. GA: 3000 ± 845.15 ml, p = 0.945). All patients in both groups reported to be satisfied with the care they received (p > 0.05); also regain of urinary continence was comparable between the two groups after 12 months. Lastly, there were no cases of biochemical recurrence in either group at the 6th and 12th postopera- tive months. When participants were sub-analysed according to BMI categories, there were no underweight patients, 24 of nor- mal weight (CESA: 10, GA: 14), 26 overweight (CESA: 16, GA: 10) and 10 obese patients (CESA: 4, GA: 6). A higher heart range change was observed in obese patients in the GA group when compared to overweight and nor- mal patients (32 vs 25 and 23, respectively; p = 0.002). There was no difference of statistical importance between any other factors, when comparing each BMI group of GA. In the CESA BMI groups, there were no statistical dif- ferences for any of the factors. DISCUSSION In this comparative study, all patients undergoing RRP for organ-confined PCa under either general or combined (epidural and spinal) anaesthesia were safely treated and discharged without any major complications. Time for induction of anaesthesia and surgical time were the same in both groups. In addition, no post-subarachnoid punc- ture headaches, nerve damages or difficulty in regaining leg motility were recorded in the CESA group whereas no cases of vomiting and/or postoperative delirium were found in the GA group. In the GA group, intraoperative heart rate was recorded higher and there was a greater drop in the post-operative mean haemoglobin value, when compared to the CESA group, potentially indicating a greater blood loss in patients under GA. Nonetheless the amount of fluids retrieved by the suction was similar in both groups, hence one has to assume that a greater amount of blood was held within the gauzes during surgery. This parameter however was not measured in our study. Shir Y et al. (10) also demonstrated mean intraoperative blood loss to be significantly higher in patients undergoing surgery under GA compared to those receiving epidural anaesthesia (respective mean values 1940 and 1490 litres) and simi- lar in those receiving combined general/epidural anaes- thesia (mean 1810 litres); they concluded that epidural anaesthesia did not reduce bleeding, it was rather the administration of GA that increased intraoperative haem- orrhage (10). The authors recognised positive pressure ventilation to be a potential contributing factor, due to the increase in intrathoracic pressure and decrease in venous return to the heart that causes (11), which in turn results in increased peripheral venous pressure (12) and conse- quent increased bleeding during surgery (13). However, contrary to the results of Shir Y et al., we found no differ- ence in blood transfusions between the 2 groups. Significantly lower blood loss with combined epidural/GA, compared to general alone, was also report- ed by others (14, 15). SAS was statistically different between the groups, with patients in the CESA group having an overall higher mean score, indicating a potentially reduced risk for postopera- tive complications. It is noteworthy that a SAS score < 6, which is deemed a threshold for increased risk for major complications, was reported in 20% of patients in the GA group, compared to none in the CESA group. This poten- tially implies a greater risk for postoperative complica- tions in those receiving GA. Postoperative complications may delay not only patients’ recovery and discharge from hospital but also return to their normal activities with an overall reduction in their quality of life (16). Nevertheless, the potential safety benefits of CESA over GA, need to be further investigated in larger-scale studies. Both groups reported equal VAS scores, with higher pain levels reported immediately after surgery and a constant reduction thereafter. In the literature, there have been reports indicating lower pain levels in patients receiving CESA. Dunet F et al. (15) demonstrated an improvement in required postoperative analgesics, within the first 48 hours, in patients undergoing RRP under combined gen- eral/epidural anaesthesia over patients receiving GA alone. This observation however, was not confirmed in the present study. Patients receiving CESA remained in the operating theatre for a shorter period of time (average -3.5 minutes), com- pared to those receiving GA, and furthermore their hos- pitalisation was significantly shorter (-0.6 days). A short- er operating theatre and hospital stay is beneficial for both patients and Health Services alike, because it reduces patients’ exposure to specific pathogens, reduces anxiety and, at the same time, reduces costs (15, 17). By stream- lining the CESA technique for RRP, the duration of sur- gery will further decrease, leaving time for more opera- tions, thereby increasing hospital incomes (18). Medical economics are equally important to other aspects of Medicine and treatment options, apart from being per- sonalized, should be cost-effective (19). In general, appli- cation of techniques which enable provision of the best health care possible, while reducing risks of hospital- acquired infections and at the same time, requiring less funds, is of great importance. Overall satisfaction at the time of discharge was similar in both groups and after a one-year of follow-up, no bio- chemical recurrences and no difference in the incidence of urinary incontinence, were reported. These results, which are in line with other reports (20), indicating that both methods of anaesthesia are safe to perform with equal oncological and functional results. BMI is another important factor that may potentially influence various parameters during the operation. We have noticed a higher intraoperative HR change in obese patients receiving GA, compared to those in the CESA group. This finding, combined with the higher drop in the mean postoperative haemoglobin level, may indicate a greater blood loss in obese patients. However, due to the Archivio Italiano di Urologia e Andrologia 2022; 94, 4 K. Pikramenos, M. Zachou, E. Apostolatou, et al. 400 small number of obese patients (10) included in the study, no clear inference can be drawn on this issue. Cai T et al. (21), in their study of 78 patients undergoing rad- ical prostatectomy, reported an increased blood loss in obese patients compared to patients with normal weight; nonetheless the differences were not statistically signifi- cant. In contrast to our results, Cai et al. also found that obese patients were significantly more likely to have uri- nary incontinence postoperatively compared to non- obese patients, a finding not observed in our study. Lastly, it should be noted that the data presented in this study apply only to patients undergoing open radical prostatectomy and not to those undergoing laparoscopic or robotic procedures. A potential advantage of either form of anaesthesia in these procedures should be inves- tigated in separate studies. CONCLUSIONS Open RRP carried out under combined spinal/epidural anaesthesia is a safe procedure to perform and is associat- ed with less intraoperative blood loss and potentially reduced risks of postoperative complications. It may lead to a shorter total operation time and reduced hospitaliza- tion, while providing similar oncological and functional outcomes. 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Correspondence Konstantinos Pikramenos, MD (Corresponding Author) kpikramenos@gmail.com Eleftheria Apostolatou, MD apostolatoy1989@gmail.com Athanasios Papatsoris, MD agpapatsoris@yahoo.gr Ioannis Varkarakis, MD medvark3@yahoo.com Iraklis Mitsogiannis, MD imitsog@med.uoa.gr 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens, Greece Maria Zachou, MD zachou.maria@yahoo.com Gastroenterology Department, Sismanoglio Hospital, Athens Greece Dimitrios Papadopoulos, MD dimitris76papadopoulos@yahoo.gr Anaesthesiology Department, Evgenidio Hospital, National and Kapodistrian University of Athens, Greece Maria Mitsogianni, MD mitsogiannimaria@gmail.com 4th Department of Medical Oncology, Hygeia Hospital, Athens, Greece