Sufentanil Sublingual Tablet System: from rationale of use to clinical practice.

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; AcelRx 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.

The impact of phone calls on follow-up rates in an online depression prevention study.

BACKGROUND: Automated Internet intervention studies have generally had large dropout rates for follow-up assessments. Live phone follow-ups have been often used to increase follow-up completion rates. OBJECTIVE: To compare, via a randomized study, whether receiving phone calls improves follow-up rates beyond email reminders and financial incentives in a depression prevention study. METHOD: A sample of 95 participants (63 English-speakers and 32 Spanish-speakers) was recruited online to participate in a "Healthy Mood" study. Consented participants were randomized to either a Call or a No Call condition. All participants were sent up to three email reminders in one week at 1, 3, and 6 months after consent, and all participants received monetary incentives to complete the surveys. Those in the Call condition received up to ten follow-up phone calls if they did not complete the surveys in response to email reminders. RESULTS: The follow-up rates for Call vs. No Call conditions at 1, 3, and 6 months, respectively, were as follows: English speakers, 58.6% vs. 52.9%, 62.1% vs. 52.9%, and 68.9% vs. 47.1%; Spanish speakers, 50.0% vs. 35.7%, 33.3% vs. 21.4%, and 33.3% vs. 7.1%. The number of participants who completed follow-up assessments only after being called at 1-, 3- and 6 months was 2 (14.3%), 0 (0%), and 3 (25.0%) for English speakers, and 2 (18.9%), 0 (0%), and 1 (7.7%) for Spanish speakers. The number of phone calls made to achieve one completed follow-up was 58.8 in the English sample and 57.7 and Spanish-speaking sample. CONCLUSIONS: Adding phone call contacts to email reminders and monetary incentives did increase follow-up rates. However, the rate of response to follow-up was low and the number of phone calls required to achieve one completed follow-up raises concerns about the utility of adding phone calls. We also discuss difficulties with using financial incentives and their implications.

PAIN OUT: the making of an international acute pain registry.

BACKGROUND: About 240 million patients undergo surgery every year, worldwide. Roughly 50% of these patients report clinically significant pain. Numerous barriers impede provision of adequate management. Lack of evidence about appropriateness and effectiveness of interventions is one. A registry can provide such information, eventually facilitating better management. This paper reports the development and feasibility of PAIN OUT, the first international acute pain registry, established with funds from the European Commission, and presents preliminary analysis to illustrate the nature of investigations that registry data make possible. METHODS: On the first postoperative day, 6347 adult patients undergoing orthopaedic or general surgery, in 11 medical centres in Europe and Israel, provided Patient Reported Outcomes (PROs) using a validated questionnaire. Clinical data were abstracted from the patient's chart. RESULTS: Feasibility worked well. Over a period of 1 year, surveyors accrued targeted data sets and entered them into an online browser. Collaborators could receive online feedback comparing their findings about PROs against anonymized findings from other centres. Missing data for the majority of variables were low. Despite considerable variability between institutions, a large number of patients were treated according to the generic, evidence-based recommendations we assessed. However, this was not sufficient to result in acceptable outcomes for the majority of patients. CONCLUSION: The initial development of PAIN OUT has been achieved. From 2013, it continues as a not-for-profit academic project, open to clinicians and researchers worldwide. The International Association for Study of Pain and PAIN OUT will work together to maintain, disseminate and develop the registry.

Feasibility of international data collection and feedback on post-operative pain data: proof of concept.

Post-operative pain exacts a high toll from patients, families, healthcare professionals and healthcare systems worldwide. PAIN-OUT is a research project funded by the European Union's 7th Framework Program designed to develop effective, evidence-based approaches to improve pain management after surgery, including creating a registry for feedback, benchmarking and decision support. In preparation for PAIN-OUT, we conducted a pilot study to evaluate the feasibility of international data collection with feedback to participating sites. Adult orthopaedic or general surgery patients consented to participate between May and October 2008 at 14 collaborating hospitals in 13 countries. Project staff collected patient-reported outcomes and process data from 688 patients and entered the data into an online database. Project staff in 10 institutions met the enrolment criteria of collecting data from at least 50 patients. The completeness and quality of the data, as assessed by rate of missing data, were acceptable; only 2% of process data and 0.06% of patient-reported outcome data were missing. Participating institutions received access to select items as Web-based feedback comparing their outcomes to those of the other sites, presented anonymously. We achieved proof of concept because staff and patients in all 14 sites cooperated well despite marked differences in cultures, nationalities and languages, and a central database management team was able to provide valuable feedback to all.

A prospective, randomized, double-blind comparison between parecoxib and ketorolac for early postoperative analgesia following nasal surgery.

BACKGROUND: The aim of this prospective, randomized, double-blind study was to compare the efficacy of parecoxibfor postoperative analgesia after endoscopic turbinate and sinus surgery, with the non-selective non-steroid anti-inflammatory drug (NSAID), ketorolac. METHODS: A total of 50 patients with an ASA physical status I-II, receiving functional endoscopic sinus surgery (FESS) and endoscopic turbinectomy after local infiltration with 1% mepivacaine, were randomly assigned to receive intravenous administration of either 40 mg parecoxib (N.=25) or 30 mg ketorolac (N.=25), 15 min before the discontinuation of anaesthesia and then every 8 h postoperatively. A blinded observer recorded the incidence and severity of pain upon admission to the postanesthesia care unit (PACU), as well as 10, 20, and 30 min after PACU admission. Thereafter, observations continued every 1 h for the first 6 h, and then 12 h and 24 h after surgery. RESULTS: The area under the curve of the visual analogue scale (AUCVAS) calculated during the study period was 635 (26-1 413) in the Parecoxib group and 669 (28-1 901) in the Ketorolac group (P=0.54). Rescue morphine analgesia was required by 12 patients (48%) in the Parecoxib group and 11 patients (44%) in the Ketorolac group (P<0.05); while mean morphine consumption was 5 +/- 2.5 mg and 5 +/- 2.0 mg in Ketorolac and Parecoxib groups, respectively (P<0.05). No differences in the incidence of side effects were recorded between the two groups. Patient satisfaction was similarly high in both groups, and all patients were discharged uneventfully 24 h after surgery. CONCLUSION: In patients undergoing endoscopic nasal surgery and local infiltration with 1% mepivacaine, parecoxib administered before discontinuing general anesthesia is as effective in treating early postoperative pain as ketorolac.

A recovery room-based acute pain service.

AIM: Despite routine postoperative pain management improves recovery and reduces postoperative morbidity and overall costs, and the availability of a large armamentarium of analgesic techniques and drugs, a significant portion of patients do not receive adequate postoperative pain control. We describe a recovery room (RR) based acute pain service model. METHODS: Guidelines on postoperative pain and therapeutic protocols were instituted in January 1999. The analgesic endpoint was a visual analogic scale (VAS) below 4 for all surgical patients for the first 48-72 h. The RR, run by one anesthesiologist and 2 nurses and one assistant, acted as a coordination centre. Discharge from the RR was subject to achieving effective analgesia. Nurses of each ward monitored VAS along with vital signs, administered rescue doses if necessary, and reported to the RR nurse when needed. RR nurses monitored the patient at least twice daily and reported to the anesthesiologist. We have distributed an anonymous questionnaire, within surgical wards, to both surgeons and nurses to evaluate their perception of pain management and of this acute pain service (APS) model. RESULTS: VAS was maintained significantly <4. Analgesic drug consumption increased between 1997, 2000 (first year of APS) and 2004. The auditing process confirmed the desire of all professional figures to be informed and involved in acute pain management as part of a coordinated and systematic approach to the surgical patient. CONCLUSION: A RR-based APS can effectively act as coordinating centre for acute pain treatment without adjunctive personnel.

Thiopental--ketamine association and low dose priming with rocuronium for rapid sequence in duction of anaesthesia for elective cesareum section.

Obstetric patients undergoing caesarean section under general anaesthesia require rapid induction due to high risk of aspiration. Rocuronium provides the shortest onset of action of nondepolarizing blocking agents. Onset time can be shortened by the priming principle. Ketamine has been shown to improve intubating conditions when used in association with rocuronium. Even if ketamine crosses the placenta rapidly, it does not produce neonatal depression unless used in doses above 1-1.5 mg x kg(-1). We present a case of elective caesarean section due to pelvic disproportion managed in general anaesthesia. Following 5 min of preoxygenation, a priming dose of 0.04 mg x kg(-1) of rocuronium was administered. The patient was maintained on spontaneous breathing with 100% oxygen by face mask for 3 min and then induced in rapid sequence with thiopental 2 mg x kg(-1), ketamine 1 mg x kg(-1) and 0.4 mg x kg(-1) or rocuronium. Intubation was performed 30 s after induction (twitch tension 17%) with an excellent clinical intubating score. No adverse events such as muscle weakness or patient discomfort were observed or reported by the patient. Time from injection of the intubating does of rocuronium to recovery of 25% of single twitch was 26 min. Recovery index (T25-75) was, instead, of 3 min and 25 s. The combination of the induction agents thiopental and ketamine, associated with low dose priming with rocuronium, have guaranteed excellent intubating conditions in this clinical context.

Intubation conditions following rocuronium: influence of induction agent and priming.

A small priming dose of rocuronium can shorten the onset time of neuromuscular blockade. Induction agents with less cardiovascular depression also reduce the onset time. We hypothesized that ketamine, compared to thiopentone, would reduce onset time and improve intubating conditions following priming. Sixty patients ASA I to II, randomized by computer-generated sequence to four groups were investigated in a double-blind controlled trial. In the two groups with priming, 0.04 mg/kg of rocuronium was followed by three minutes of priming interval. Induction was followed by an intubation dose of 0.4 mg/kg of rocuronium. After 30 seconds, intubation was attempted within a further 20 seconds. In the two control groups, the same sequence was repeated except sham priming (saline) was given. For induction, S-ketamine (1 mg/kg) or thiopentone (4 mg/kg) were administered. Intubating conditions were graded as excellent, good, poor, or not possible. Neuromuscular transmission was monitored by acceleromyography of the thumb. There were no measured differences in onset time of neuromuscular block or in haemodynamics between the groups. The proportion of good to excellent intubating conditions was higher when ketamine was preceded by priming compared to ketamine without priming (87% vs 20%; P<0.05). In both priming and control groups intubating conditions were improved when using ketamine compared to thiopentone (P<0.05). The mechanism of this effect was not clear from this study.

Effects of ephedrine on intubating conditions following priming with rocuronium.

BACKGROUND: Onset of action of muscle relaxants is influenced by cardiac output and muscle blood flow. Ephedrine reduces the onset time of rocuronium. Onset is also shortened by priming. Accordingly, we hypothesized that priming combined with ephedrine is superior to either technique used separately. METHODS: Four groups of randomly allocated patients (n = 31), ASA I - II, were induced with propofol 2.5 mg kg(-1). In groups I and II, 0.04 mg kg(-1) of rocuronium was followed by a 3-min priming interval. Induction was followed by an intubation dose of 0.04 mg kg(-1). Then a 30-s intubation was attempted. In groups III and IV the same sequence was repeated except for sham priming and an intubation dose of 0.44 mg kg(-1). In groups I and II, ephedrine (210 microg kg(-1)) was injected before propofol. In groups II and V, an equivalent volume of normal saline was injected. Jaw relaxation, vocal cord position, and diaphragmatic response were used to assess intubating conditions. RESULTS: All patients of group I were intubated 30 s after the intubating dose and within a 20-s interval compared with 74% of patients in groups II and III, and 84% of patients in group IV. Intubating conditions were graded good to excellent in all patients in group I compared with 42% of those in group II, 35% in group III and 52% in group IV (P < 0.01 vs. group I). During the priming interval, no adverse effects were observed or reported. CONCLUSIONS: Ephedrine in combination with propofol significantly improved clinical intubating conditions at 30 s following priming with rocuronium compared with priming with ephedrine without priming.

Epidural anaesthesia for endovascular stent graft repair of a ruptured thoracic aneurysm.

We present a case report of the anaesthetic management of a 77-year-old man requiring endovascular thoracic stent graft repair. The patient had a history of poorly controlled type II diabetes mellitus and chronic renal failure. Chest X-ray and CT scan showed a right pleural effusion, generalized emphysema and an enlarged thyroid extending into the upper mediastinum, compromising the tracheal lumen. Endovascular stent graft repair was successfully performed under epidural anaesthesia and intravenous sedation.

[Analysis and comparison of the guidelines regarding recovery-room management]. / Analisi e confronto delle linee guida riguardanti la gestione della recovery-room.

The purpose of this study was to analyse and compare the guidelines regarding Recovery-Room (RR) management at international level, pointing out the main differences and common aspects. The guidelines on the RR management in various countries have been compared in particular the Italian, French, German, Australian, Canadian and American guidelines. In addition, the management of postoperative patients in some of these countries where guidelines on the subject have not yet been published have been analysed. In some countries, France for instance, the guidelines have been published as a ministerial decree (Décret n degrees 94-1050 du Décembre 1994) and are therefore a law with proper articles, in others (Italy for instance), they are mere recommendations, which do not have immediate effect and are regarded as a target to be achieved. SIAARTI considers that this is due to the dishomogeneity of the Italian hospital situation as far as medical and nursing staff as well as buildings and applied technology are concerned. The comparison between guidelines of different countries has shown that RR is a reality which has now existed for many years at international level and it has demonstrated that all guidelines agree on the fact that postoperative patients must be observed in a protected and safe environment. The following rules are common to all guidelines: the anaesthetist is responsible for the RR and for discharging the patient; there must be a clinical record and a written report which are considered to be essential (not in Italy); RR must be next to the surgical rooms; the patient must be escorted to RR by the anesthetist; monitoring must be guaranteed during transfer; monitoring continuity in RR (at regular and a appropriate intervals) is essential. The following rules are not common to all guidelines: numbers of beds in RR; the proportion between the number of nurses and the number of patients; regulation for day-surgery; specific regulations for obstetrical patients. Guidelines are subject, as any regulation, to continuous revision, and this is a very important requirement which helps keeping them always update and in line with scientific research.

[Recovery Room. Organization and clinical aspects]. / Recovery Room. Aspetti clinici e organizzativi.

Correct administration in the early postoperative phase is decisive in the final outcome of surgery and the presence of the Recovery Room (RR) contributes significantly to a reduction in the post-operative risk rate. The objectives of the RR are: removal of the pharmacological effect of general anaesthesia; stabilization of vital parameters (circulation and ventilation); stabilization of body temperature; control of the hydro-electrolytic balance; intensive intervention in the case of an acute complication; prescribing a suitable postoperative analgesia; recovering movement in the case of loco-regional anesthesia. Organization of RR must take into consideration: 1) aspect of environment and location; 2) transport of the patient from the operating room to the RR; 3) definition of the equipment necessary for the RR; 4) definition of the role and qualification of the medical and nursing staff; 5) definition of regulations of assistance and the clinical file; 6) definition of criteria for discharge and transfer; 7) definition of means of adjournment, improvement and comparison with other similar structures. RR is administered by an Anesthetist with clinical, therapeutic and decision-making responsibility for the discharge of patients, while the supervision and assistance patients is entrusted to specialised professional nurses. From a clinical point of view the following data are monitored and recorded: the vital signs (passage of air-ways, cardiac and respiratory frequency, arterial pressure, saturation of O2, EtCO2 (in patient with air-way support), body temperature and the state of consciousness, instrumental monitoring of the patient (at pre-established time intervals), control of the skin, the peripheral circulation, surgical wounds, drainage and catheters. The percentage of incidence of complications in RR varies from 6-7 to 30% depending on various studies, probably in relation to the diversity of criteria in defining the complication. The principal complications which can be found in RR, reported in several studies are: respiratory (obstruction of the air-way, hypoxemia, hypoventilation, inhalation), cardio-circulatory (hypotension, hypertension, arrhythmia, myocardial ischemia), postoperative nausea and vomiting, hypothermia and hyperthermia, delayed re-awakening, disorientation and hyper-excitability, postoperative shivering. As long as the patient can be discharged from the RR the following requisites must be satisfied: return of a state of consciousness, stable cardio-circulatory parameters, absence of respiratory depression, absence of bleeding, absence of nausea and vomiting, good analgesia and recovery of movement in the case of loco-regional anesthesia (on this last point not all authors agree). What has been said until now shows the function, usefulness and importance of RRs which must not replace the Intensive Therapy Units. In fact, they are places where the cure must be concluded, in which the Anesthetist is responsible for the whole process. This cure must begin in the preoperative period, continue in the intraoperative period and it is compulsory to proceed in the immediate postoperative period until such a time that, because of the anesthesia administered, the clinical situation of the patient ceases to be considered a potential medical-surgical urgency-emergency .

[Recovery Room. One-year experience]. / Recovery Room. Esperienza di un anno d'attivita.

BACKGROUND: The objective of our study is to present the analysis of the organizational and clinical work carried out in the first year of activity of the Recovery Room (RR) at the Azienda Ospedaliera Santa Maria degli Angeli of Pordenone and to compare personal experience with what is stated in the literature. METHODS: The RR is located at the center of the operating block (composed of 10 operating rooms), the number of bed is 6, 3 of which are equipped with ventilators. There is a central nursing station where it is possible to concentrate all data deriving from the single monitors on one single screen. The RR operates from Monday to Friday from 8.00 to 20.00. An Anesthetist is on duty for the 12 hours and has the clinical, therapeutic and decision-making responsibility regarding the discharge of patients, while nursing assistance is provided by 2 qualified professional nurses for shift, assisted by an auxiliary. In the first year of activity of the RR, a total of 11,626 surgical operations were carried out; of these 1,047 patients, equal to 9%, were assisted in the RR. The age of 51% of the patients was between 61 and 80 years; 53.3% belonged to the ASA 2 group and only 0.48% to the ASA 4 group. The operations were sub-divided as follows: 56.8% general, thoracic and vascular surgery, 15.3% urological, 10% orthopedic, 7.7% obstetrical and gynecological, 6.1% ENS, 3% stomatological, 1% others. 56.8% off the patients underwent general anesthesia, 30.5% combined anesthesia and 12.6% local-regional anesthesia. The time spent by the patients in RR was between 1 hour 30 minutes and 10 hours 45 minutes, with an average time of 3 hours 49 minutes. RESULTS: Of the 1,047 patients studied no case of cardio-respiratory arrest or death was recorded, while the complications encountered were: 13.15% cardio-circulatory, 3.62% respiratory, 3.62% PONV, 2.1% oliguria, 1.24% hypothermia, 0.48% disoriented patients, 0.38% hyperthermia and 0.38% shivering. In the area of cardio-circulatory complications encountered, the most important was arterial hypertension (5.6%), followed by cardiac arrhythmia, such as bradycardia (2.5%) and tachycardia (2.6%). CONCLUSIONS: The conclusion is drawn that correct administration in the early postoperative period is decisive for the final outcome of surgery and that the presence of RR contributes significantly to a reduction in the postoperative morbidity rate. Our case-series leads us, however, to reflect on an excellent organization of the opening hours of RR.

[Severe and prolonged EEG depression after induction of general anesthesia for carotid endarterectomy. Report of a clinical case]. / Grave e prolungata depressione elettroencelografica all'induzione di un'anestesia generale per TEA carotidea. Descrizione di un caso clinico.

A large number of methods are available for intraoperative neurologic monitoring during endarterectomy, although no single method is infallible. Debate over choice of regional or general anesthesia for this surgery persists because of differing conclusions of various studies of risks and benefits. The case of patient undergoing left carotid endarterectomy under general anesthesia is described, in whom after the induction of anesthesia with: midazolam 2 mg, fentanyl 50 g, propofol (fractionate dose of 180 mg) and cisatracurium 12 mg, a total EEG depression occurred persisting for over 10 minutes and was followed by slow recovery, during the awakening of the patient. No significant hemodynamic changes were noted during the induction. No neurologic deficit was observed in the patient after arousal. It is suggested that the probable reason for the EEG response is the particular sensitivity of the patient to some of the induction drugs or to their association. Two weeks later surgery was successfully performed using cervical plexus block, without any anesthetic support. Regional anesthesia allows continuous neurologic assessment of the awaken patient, it is the most sensitive method for detecting inadequate cerebral perfusion and function.

[Complications related to epidural catheter in caesarean delivery]. / Complicanze correlate al catetere epidurale in taglio cesareo.

A review of complications related to epidural catheters in caesarean delivery is presented. Catheters for prolongation of nerve blocks were first used in 1940s. Thereafter, there has been steady development in the design and plastic material technology of the different catheters. In the last decade the regional anaesthesia for caesarean section became very popular, as well as continuous increase in the use of epidural catheters. The anatomical changes of pregnancy like marked distension of the epidural veins resulted in increased risk of the complications due to the epidural catheter placement. It is likely that permanent neurologic sequelae due to regional anaesthesia in obstetrics almost never occur, while minor self-limiting complications do occur. The possible complications of epidural catheter techniques are: trauma, malposition and migration of the catheter, knotting and breaking, radiculopathy, dural puncture, subdural injection, abscess and infection, haematoma and wrong solution injection. Most of the malpositions of the epidural catheter can be avoided by a careful technique, advancing the catheter with no forceful movement and not more than 3 to 4 cm into epidural space. Broken parts of the catheters should be left as a rule within the spinal space. Test dose should be always done for continuous epidural anaesthesia. Early diagnosis and prompt appropriate treatment will usually lead to complete resolution of the neurological deficit even in cases of epidural haematoma or abscess.

[Complications of pediatric anesthesia. Survey carried out by the Study Group SIAARTI for anesthesia and intensive therapy in children]. / Le complicanze in anestesia pediatrica. A cura e per l'iniziativa del Gruppo di Studio SIAARTI per l'anestesia e la terapia intensiva in età infantile.

This study was designed to asses in a prospective survey the intra and post-operative adverse outcome of paediatric patients in Italy. The data was carried out in representative samples of anaesthetics performed in different Italian Institutions, which were chosen by the National Study Group for Paediatric Anaesthesia, and included: paediatric, general, specialistic hospitals and departments. A total of 9289 anaesthetics were collected and studied. The mean age of the patients was 62.5 months. In the 320 cases (3.4%) 299 minor (3.2%) and 21 major (0.2%) complications occurred during or within 24 hours of surgery and anaesthesia. Seven of the major complications resulted in the exitus of the patients (0.07%). Fifty percent of the accidents regarded respiratory and twenty percent cardiovascular systems. The major incidence (risk factors) of the minor complications was present in patients less than 6 months, ASA group 2-3-4, emergency surgery, patients with associated pathology, long duration of anaesthesia and high risk operations. The incidence of the major complications appears closely related to: patients age and clinical assessment, weight, ASA group, kind of the operation, indications and durations of the surgery, while in the exitus group the major risk factor is the preoperative pathology, surgical procedures, and then: age, weight, ASA and finally surgery.