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Stefano Turi, Francesco Deni, Gaetano Lombardi, Marilena Marmiere, Francesco Giuseppe Nisi, Luigi BerettaDipartimento di Anestesia e Rianimazione, Ospedale San Raffaele, Milano, ItalyBackground: The Sufentanil Sublingual Tablet System (SSTS) is a new, pre-programmed, noninvasive, handheld system for patient-controlled analgesia (PCA) which may allow a faster postoperative recovery compared with standard PCA. The efficacy of SSTS in controlling pain after open abdominal surgery has already been documented. However, to our knowledge SSTS has never been investigated in patients undergoing major surgery within an Enhanced Recovery After Surgery (ERAS) protocol.Methods: This observational, retrospective analysis included consecutive patients undergoing elective major abdominal and gynecological surgery. All patients received the SSTS device once they were fully awake and had a good control of pain at the end of the surgery. We analyzed changes in pain intensity according to the numerical rating scale (NRS) throughout the treatment as well as its duration, the number of administrations, and possible related adverse events. Patients were also interviewed to assess their quality of sleep and overall satisfaction with the SSTS device.Results: The study included 308 patients. Compared to the first SSTS administration, pain intensity decreased from a median NRS of 6 to 0 at day 3, for an overall reduction of 79%. Results were already statistically significant at postoperative day 1 (p

Stefano Turi, Francesco Deni, Gaetano Lombardi, Marilena Marmiere, Francesco Giuseppe Nisi, Luigi Beretta Dipartimento di Anestesia, Ospedale San Raffaele, Milano, ItalyCorrespondence: Stefano TuriDepartment of Anesthesiology, Vita-Salute, University, San Raffaele Hospital, Via Olgettina 60, Milan 20132, ItalyTel + 39 02 2 643 2656Email turi.stefano@hsr.it We thank Wang and Miao1 for their interest in our recent publication2 and the appreciation of our work. We agree with them on the need of using repeated-measures analysis to evaluate pain intensity at different timepoints. We acknowledge that, for the sake of brevity, our manuscript did not properly clarify the statistical methods used for the analysis and we take this opportunity to better explain them. We performed a repeated measure analysis of variance (ANOVA) to compare pain intensity on different time points. The analysis resulted statistically significant (p

The control of post-operative pain in Italy and other western countries is still suboptimal. In recent years, the Sufentanil Sublingual Tablet System (SSTS; Zalviso; Acel-Rx Pharmaceuticals, Redwood City, CA, USA), which is designed for patient-controlled analgesia (PCA), has entered clinical practice. SSTS enables patients to manage moderate-to-severe acute pain during the first 72 postoperative hours directly in the hospital setting. However, the role of SSTS within the current framework of options for the management of post-operative pain needs to be better established. This paper presents the position on the use of SSTS of a multidisciplinary group of Italian Experts and provides protocols for the use of this device. [ABSTRACT FROM AUTHOR]

Background & Aims: Patients with early-onset colorectal cancer (eoCRC) are managed according to guidelines that are not age-specific. A multidisciplinary international group (DIRECt), composed of 69 experts, was convened to develop the first evidence-based consensus recommendations for eoCRC., Methods: After reviewing the published literature, a Delphi methodology was used to draft and respond to clinically relevant questions. Each statement underwent 3 rounds of voting and reached a consensus level of agreement of ≥80%., Results: The DIRECt group produced 31 statements in 7 areas of interest: diagnosis, risk factors, genetics, pathology-oncology, endoscopy, therapy, and supportive care. There was strong consensus that all individuals younger than 50 should undergo CRC risk stratification and prompt symptom assessment. All newly diagnosed eoCRC patients should receive germline genetic testing, ideally before surgery. On the basis of current evidence, endoscopic, surgical, and oncologic treatment of eoCRC should not differ from later-onset CRC, except for individuals with pathogenic or likely pathogenic germline variants. The evidence on chemotherapy is not sufficient to recommend changes to established therapeutic protocols. Fertility preservation and sexual health are important to address in eoCRC survivors. The DIRECt group highlighted areas with knowledge gaps that should be prioritized in future research efforts, including age at first screening for the general population, use of fecal immunochemical tests, chemotherapy, endoscopic therapy, and post-treatment surveillance for eoCRC patients., Conclusions: The DIRECt group produced the first consensus recommendations on eoCRC. All statements should be considered together with the accompanying comments and literature reviews. We highlighted areas where research should be prioritized. These guidelines represent a useful tool for clinicians caring for patients with eoCRC., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Pain management after surgery is crucial to decrease perioperative morbidity and mortality. Acute pain services (APS) are multidisciplinary teams that represent a modern strategy to address pain inside hospitals. The APS defines and applies pain treatment protocols specific for each surgery. To evaluate the performance of the APS at our institute, we performed a large retrospective cohort study focusing on complications of epidural analgesia and IV opiates., Methods: Data from the 10 years of activity of the APS were collected. Pain was assessed using the VAS at rest (VASr) and during movement (VASm) at each daily visit; the presence of side effects and complications was also assessed., Results: A total of 17,913 adult patients were followed by APS during the study period. Epidural analgesia was used in 7,776 cases (43%), while 9,239 (52%) patients used IV patient-controlled analgesia (PCA). A combination of the 2 was used in 87 patients (0.5%). A total of 456 perineural catheters (2.6%) were placed, while 442 patients(2.5%) used other analgesic techniques. We recorded 163 dural punctures during catheter placement, with no epidural hematoma, epidural abscess, or meningitis, and no permanent modification in sensitive or motor functions., Conclusions: In our large case series, APS was confirmed safe and effective in treating postoperative pain, using both epidural analgesia and IV PCA with morphine., (© 2019 World Institute of Pain.)

Aim: The aim of this prospective study was to determine the effect site concentrations of remifentanil maintaining cardiovascular homeostasis in response to surgical stimuli during bispectral index (BIS) guided propofol anesthesia in seriously obese patients., Methods: Twenty-two patients, female/male 15/7, ASA physical status II - III, aged 29-69 years, body mass index (BMI) 54.5+/-12, undergoing major open bariatric surgery, were enrolled to receive a propofol-remifentanil total intravenous anesthesia. All patients were intubated by using a flexible fiberoptic bronchoscopic technique facilitated by a target controlled effect site concentration of remifentanil set at 2.5 ng/mL. After endotracheal intubation, anesthesia was started with a target controlled infusion of propofol initially set at 6 microg/mL, then adjusted to maintain a BIS value between 40 and 50. The mean effect site concentration of remifentanil was recorded at different intervals time during surgery: skin incision-opening of peritoneum (T1), bowel resection (T2), cholecystojejunal anastomosis (T3), ileojejunal anastomosis (T4), closing of peritoneum (T5)., Results: The mean plasma concentrations of propofol required to maintain a BIS value between 40 and 50 were 4+/-0.55, 3.8+/-0.64, 3.8+/- 0.63, 3.8+/-0.65 and 3.8+/-0.63 microg/mL at T1, T2, T3, T4 and T5 interval time, respectively. The mean values of remifentanil target effect site concentration were 5.2+/-1.3, 7.7+/-1.7, 9.1+/-1.8, 9.7+/- 2.2 and 9.9+/-2.5 ng/mL at T1, T2, T3, T4 and T5 interval time., Conclusions: This study suggests that tolerance to remifentanil infusion is profound and develops very rapidly in morbidly obese patients submitted to open bariatric surgery during BIS guided propofol anesthesia. The administration of opiates during anesthesia based on target-controlled infusion should include corrections for the development of tolerance.

Aim: The institution of a postoperative Acute Pain Control Service is mandatory to improve the control of pain induced by surgical injury. Treatment of postoperative pain may be achieved using a combination of analgesic agents and techniques, reducing the incidence of side effects owing to the lower doses of the individual drugs. In 1997 we established an Acute Pain Service (APS) at the San Raffaele Hospital in Milan. The aim of this study was to assess the efficacy and safety of our APS both in terms of treatment protocols and organisational issues., Methods: In this prospective observational study we included 592 patients undergoing abdominal, gynecological, or orthopedic surgery with severe expected pain. According to general guidelines on pain treatment, the patients were assigned to different treatment protocols based on the kind of operation. All protocols were based on the multimodal therapy, with the association of nonsteroidal anti-inflammatory drugs (NSAIDS), opioids and regional anesthesia techniques. During the first 48 h of the postoperative period we recorded vital signs, level of pain and occurrence of any side effect., Results: Our analgesic protocols proved to be effective and safe (low incidence of side effects) for every surgery. The incidence of postoperative nausea and vomiting was higher in patients receiving patient-controlled morphine than that with continuous epidural or nerve block. After lower abdominal surgery, pain at movement at 24 h was significantly lower in the epidural group than in the Patient Control Analgesia group. Nausea and vomiting, numbness and paresthesias at the lower limbs were higher in gynecological patients. A larger percentage of orthopedic patients in the epidural group reported numbness and paresthesias at the lower limbs in comparison with patients receiving continuous peripheral nerve block., Conclusion: In agreement with previous literature, this study confirmed that a multimodal approach to pain treatment provides an adequate control of postoperative pain, minimizing side effects.

Unlabelled: We compared the effects of a laparoscopic (n = 23) versus laparotomic (n = 21) technique for major abdominal surgery on temperature control in 44 patients undergoing colorectal surgery during a combined epidural/general anesthesia. A thoracic epidural block up to T4 was induced with 6-10 mL of 0.75% ropivacaine; general anesthesia was induced with thiopental, fentanyl, and atracurium IV and maintained with isoflurane. Core temperature was measured with a bladder probe and recorded every 15 min after the induction. In both groups, core temperature decreased to 35.2 degrees C (range, 34 degrees C-36 degrees C) at the end of surgery. After surgery, normothermia returned after 75 min (60-120 min) in the Laparoscopy group and 60 min (45-180 min) in the Laparotomy group (P = 0.56). No differences in postanesthesia care unit discharge time were reported between the two groups. The degree of pain during coughing was smaller after laparoscopy than laparotomy from the 24th to the 72nd observation times (P < 0.01). Morphine consumption was 22 mg (2-65 mg) in the Laparotomy group and 5 mg (0-45 mg) in the Laparoscopy group (P = 0.02). The time to first flatus was shorter after laparoscopy (24 h [16-72 h]) than laparotomy (72 h [26-96 h]) (P = 0.0005), and the first intake of clear liquid occurred after 48 h (24-72 h) in the Laparoscopy group and after 96 h (90-96 h) in the Laparotomy group (P = 0.0005). Although laparoscopic surgery provides positive effects on the degree of postoperative pain and recovery of bowel function, the reduction in heat loss produced by minimizing bowel exposure with laparoscopic surgery does not compensate for the anesthesia-related effects on temperature control, and active patient warming must also be used with laparoscopic techniques., Implications: This prospective, randomized, controlled study demonstrates that laparoscopic colorectal surgery results in less postoperative pain and earlier recovery of bowel function than conventional laparotomy but does not reduce the risk for perioperative hypothermia. Accordingly, active warming must be provided to patients also during laparoscopic procedures.

Over the past few years, increasing emphasis has been placed on the need to improve the management of acute pain. Despite a growing trend in acute pain management, many difficulties are still present for the treatment of postoperative pain. Loco-regional techniques together with an effective pain management should accelerate rehabilitation, decrease risk of postoperative complications and speed return to normal activities. A multimodal approach should be used for a reduction of pharmacological side effects, improving pain reduction. The association between NSAIDs and opioids permits reduction of full dose opioids with better pain relief and less side effects. If NSAIDs are contraindicated, acetaminophen is an alternative, though considered by someone to be an NSAID It's action is believed to result from inhibition of prostaglandin synthesis within the central nervous system. It doesn't cause gastrointestinal ulceration or bleeding, but we have to note that large amounts may lead to hepatic necrosis. Newer NSAIDs (COX-2 inhibitors), affect mainly COX-2, and appear to be associated with less adverse effect. Rofecoxib showed a reduction of morphine consuming after spinal fusion and has been admitted by FDA for the treatment of post operative pain. Newer methods of pain relief, as patient controlled analgesia (PCA), can provide excellent and safe pain relief. When high-tech options such as PCA are used, patients need a management by an anesthesiologist-based acute pain service (APS), allowing a better pain relief with less side effects compared to patients supervised by less experienced medical staff.

Background: The aim of this prospective, randomized study was to compare the effects on intraoperative cardiovascular homeostasis, recovery profile and postoperative oxygen saturation after sevoflurane anesthesia with small doses of either remifentanil or fentanyl in combination with postoperative epidural analgesia., Methods: With Ethical Committee approval and written patient consent, 30 ASA physical status I-II patients scheduled for elective upper abdominal surgery were randomly allocated to receive sevoflurane general anesthesia implemented with small doses of either remifentanil (n = 15) or fentanyl (n = 15), followed by postoperative epidural analgesia. Remifentanil group patients received a 1 mg kg-1 bolus infused during a 60 sec period followed by a 0.15 mg kg-1 min-1 infusion; while patients of Fentanyl group were given a 3 mg kg-1 initial dose followed by 50 mg boluses as requested (according to the time to peak effect of the two drugs, the initial dose was given 5 min before induction in Fentanyl group, and 1 min before induction in Remifentanil group). Postoperatively, oxygen saturation was continuously recorded and stored on a computer during the first 12 h after surgery. SpO2 decrease < 90% for more than one minute was considered as a minor respiratory complication., Results: The median sevoflurane's MAC-hour was 2.7 (1.4 - 4.9) in patients receiving remifentanil infusion and 4.1 (2.2 - 5.7) in those patients receiving fentanyl during surgery (P = 0.005). However, no differences in the recovery times were observed between the two groups. Similar pain relief was reported during coughing in the two studied groups at discharge from the recovery area and during the following study period. No major respiratory complication was observed throughout the study. Oxygen therapy was required in three patients of Fentanyl group only 20% (P = 0.22); however, 11 patients in the same group (73%) showed at least one minor respiratory complication (SpO2 < 90% for more than 1 min), with a median of 1 (range 0 - 12) episode per patient, compared with no episode in Remifentanil group (P = 0.0005)., Conclusions: Implementing sevoflurane anesthesia with very small remifentanil infusion provides a safe and effective hemodynamic control reducing sevoflurane consumption during the procedure, and produces less respiratory effects postoperatively as compared with intermittent bolus administration of fentanyl.

Unlabelled: We compared the recovery profile and postoperative SpO(2) after the administration of general anesthesia with either sevoflurane-remifentanil or sevoflurane-sufentanil in 30 healthy patients undergoing upper abdominal surgery. They were randomly allocated to receive general anesthesia with sevoflurane and small doses of either remifentanil (n = 15) or sufentanil (n = 15), followed by postoperative epidural analgesia. The median sevoflurane minimum alveolar anesthetic concentration-hour was 2.3 (1.2-6.3) in group Remifentanil and 2.6 (1.4-5.2) in group Sufentanil (P: = 0.39), while the median consumption of remifentanil was 1.3 mg (0.7-3.4 mg) and sufentanil 0.09 mg (0.05-0.6 mg). Tracheal extubation required 10 min (6-18 min) with remifentanil and 14 min (8-24 min) with sufentanil (P: = 0.05); however, no differences in time to discharge from the recovery area were reported (24 min [12-75 min] with remifentanil and 30 min [12-135 min] with sufentanil; P: = 0. 35). From the first to seventh hour after surgery, SpO(2) was decreased more in the sufentanil than in the remifentanil group (P: = 0.001), and seven patients in the sufentanil group showed at least one episode with SpO(2) < or = 90% for more than 1 min (P: = 0.006) (median: 1 episode; range: 0-17 episodes; P: = 0.003). When added to sevoflurane, remifentanil is as effective as sufentanil during the intraoperative period, but provides shorter time to tracheal extubation and fewer effects on postoperative SpO(2) in the first 7 h after surgery., Implications: In this double-blinded study, we evaluated the effects of adding small infusions of either remifentanil or sufentanil to sevoflurane in combination with postoperative epidural analgesia for upper abdominal surgery. We demonstrated that remifentanil is as effective as sufentanil during the intraoperative period, but that it provides shorter time to extubation and fewer effects on postoperative SpO(2) in the first 7 h after surgery.

Background: To compare in a prospective, randomized study the effects on cardiovascular changes after tracheal intubation produced by small doses of either remifentanil or fentanyl., Methods: With Ethical Committee approval, after intravenous midazolam premedication (0.05 mg.kg-1), 30 normotensive, ASA physical status I-II patients, without cardiovascular or respiratory diseases, and with a Mallampati score < 2, were randomly allocated to receive an intravenous bolus of either 3 micrograms.kg-1 fentanyl (n = 15) or 1 microgram.kg-1 remifentanil (n = 15) infused over 60 sec and followed by a 0.15 microgram.kg-1.min-1 continuous intravenous infusion. General anesthesia was then induced with propofol (2 mg.kg-1), followed by atracurium besilate (0.5 mg.kg-1) to facilitate tracheal intubation. Following intubation, the lungs were ventilated mechanically using a 60% nitrous oxide in oxygen mixture with a 1% inspired fraction of sevoflurane. Arterial blood pressure and heart rate were recorded before anesthesia induction (baseline), one minute after induction of anesthesia, immediately after tracheal intubation and every minute for the first five minutes after intubation., Results: Systolic arterial blood pressure values were significantly higher in the Fentanyl than in the Remifentanil group patients from 2 to 5 min after tracheal intubation (p < 0.01), while no differences were observed between the two groups in either diastolic arterial blood pressure or heart rate values. Four patients in the Remifentanil group (26%) but only one patient in the Fentanyl group (7%) showed systolic blood pressure values < 90 mmHg during the study period (p = not significant); however, the observed decreases in systolic arterial blood pressure values were transient and did not require treatment for any subject., Conclusion: We conclude that in healthy normotensive patients, the control of cardiovascular responses to tracheal intubation obtained with a 1 microgram.kg-1 loading dose of remifentanil is more effective than that provided by a 3 micrograms.kg-1 bolus of fentanyl, with the advantage of no risks for postoperative respiratory depression.

Background: To compare intra- and postoperative clinical properties of interscalene brachial plexus block performed with either 0.5% ropivacaine or 0.5% bupivacaine., Experimental Design: prospective, randomized, double-blind study., Setting: in patient at the University Hospital, Department of Orthopedic Surgery., Patients: 30 ASA physical status I-II patients scheduled for elective shoulder surgery., Interventions: interscalene brachial plexus block was performed using the multiple injection technique and a nerve stimulator by injecting 20 ml of either 0.5% ropivacaine (n = 15) or 0.5% bupivacaine (n = 15). Postoperative analgesia consisted of 100 mg intravenous ketoprofen, if required. A blind observer evaluated hemodynamic variables as well as sensory and motor blocks from the end of injection to achieve a surgical anesthesia (readiness for surgery: loss of pinprick sensation from C4 to C7 with the inability to elevate the operated limb against gravity). The time lasting from block placement to first requirement for postoperative pain medication was also recorded., Results: No differences in anthropometric parameters and hemodynamic variables were observed throughout the study, and no signs of central nervous system (CNS) and cardiovascular toxicity, or other untoward events were reported in any patients. Readiness for surgery was obtained after 28 +/- 15 min with 0.5% bupivacaine and 22 +/- 8 min after 0.5% ropivacaine (p = NS). No differences in postoperative pain relief was observed between the two groups (11.1 +/- 5 hrs after 0.5% ropivacaine and 10.9 +/- 3.9 hrs after 0.5% bupivacaine, respectively)., Conclusions: This study confirmed that 0.5% ropivacaine has clinical properties similar to those of 0.5% bupivacaine, when used for interscalene brachial plexus block, providing similarly long duration in postoperative pain relief. Compared with bupivacaine, ropivacaine has the further advantage of a lower potential for central nervous system and cardiovascular toxicity.

Purpose: To compare analgesic efficacy and occurrence of motor block and other side effects during patient supplemented epidural analgesia (PSEA) with either ropivacaine/fentanyl or bupivacaine/fentanyl mixtures., Methods: In a prospective, randomized, double-blind study, 32 ASAI-III patients undergoing major abdominal surgery received an epidural catheter at the T8- T10, followed by integrated general epidural anesthesia. Postoperative epidural analgesia was provided using a patient controlled pump with either ropivacaine 0.2%/2 microg x ml(-1) fentanyl (group Ropivacaine, n = 16) or bupivacaine 0.125%/2 microg x ml(-1) fentanyl (group Bupivacaine, n = 16) [background infusion 4-6 ml x hr(-1), 1.5 ml Incremental Doses and 20 min lock out]. Verbal pain rating score, number of incremental doses, consumption of epidural analgesic solution and rescue analgesics, sedation (four-point scale), and pulse oximetry were recorded by a blind observer for 48 hr after surgery., Results: No differences in pain relief, motor block, degree of sedation, pulse oximetry and other side effects were observed between the two groups. The number of incremental doses and the volume of analgesic solution infused epidurally were higher in patients receiving the bupivacaine/fentanyl mixture (10 [0-52] I.D. and 236 [204-340] ml) than in patients receiving the ropivacaine/fentanyl solution (5 [0-50] I.D. and 208 [148-260] ml) (P = 0.03 and P = 0.05, respectively)., Conclusion: Using a ropivacaine 0.2%/2 microg x ml(-1) fentanyl mixture for patient supplemented epidural analgesia after major abdominal surgery provided similar successful pain relief as bupivacaine 0.125%/2 microg x ml(-1) fentanyl, but patients receiving bupivacaine/fentanyl requested more supplemental.