[Old and New Regional Anesthesia Procedures Under Review - Abdomen to Toe]. / Alte und neue Regionalanästhesieverfahren unter Review ­ Bauch bis Fußzehe.

Ultrasound (US) technology has significantly expanded the spectrum of regional anesthesiological procedures in recent years. Abdominal wall blocks are becoming an increasingly integral part of a multimodal postoperative pain concept after abdominal surgery, gynecological or urological interventions. Thoracic epidural analgesia remains the gold standard for extensive surgery. The requirement for rapid postoperative mobilization and discharge after lower extremity surgery has led to the abandonment of neuroaxial or plexus blocks in favor of selective, peripheral blocks such as the PENG block or adductor canal block. The following article is intended to show the reader the change in the use of regional anesthesiological procedures for abdominal wall and lower extremity blocks using selected blockages.

Severity of spinal degeneration does not affect the pain reduction under continuous epidural analgesia.

PURPOSE: To outline clinical effectiveness of continuous epidural analgesia (CEA) in patients with failed back surgery syndrome (FBSS) or lumbar spinal stenosis (LSS) depending on severity of spinal degeneration. METHODS: In this retrospective cohort study, all patients with FBSS or LSS who underwent CEA within an inpatient rehabilitation program were evaluated. The pain reduction was measured by VAS on an hourly basis. Substantial pain reduction was defined as a minimal clinically important difference (MCID) > 50%. Severity of spinal degeneration, side effects and patient-specific characteristics were documented. RESULT: We included a total of 148 patients with 105 patients suffering from FBSS and 48 with LSS. The average pain reduction was - 37.6 ± 19.2 in FBSS and - 38.1 ± 17.8 in LSS group (p < .001 and p < .001, respectively). In the FBSS group, sensory deficits (p = .047) and numbness (p = .002), and in the LSS group, a severe disability measured by ODI (38.2 ± 15.4 vs. 57.3 ± 11.3, p < .001) significantly contributed to a worse outcome. The severity of the spinal degeneration and psychological disorders did not affect the pain reduction in terms of MCID. CONCLUSIONS: This study provides new evidence about CEA in the treatment of FBSS and LSS. CEA provides a significant pain reduction even under intensified physiotherapeutic exercising in patients with severe spinal degeneration and a broad variety of secondary diagnoses. Neurologic deficits in case of FBSS and severe disability in case of LSS may be risk factors for less favorable outcome.

Phylogenomics and evolutionary history of Oreocnide (Urticaceae) shed light on recent geological and climatic events in SE Asia.

Climate change and geological events have long been known to shape biodiversity, implying that these can likewise be viewed from a biological perspective. To study whether plants can shed light on this, and how they responded to climate change there, we examined Oreocnide, a genus widely distributed in SE Asia. Based on broad geographic sampling with genomic data, we employed an integrative approach of phylogenomics, molecular dating, historical biogeography, and ecological analyses. We found that Oreocnide originated in mainland East Asia and began to diversify ∼6.06 Ma, probably in response to a distinct geographic and climatic transition in East Asia at around that time, implying that the last important geological change in mainland SE Asia might be 1 Ma older than previously suggested. Around six immigration events to the islands of Malesia followed, indicating that immigration from the mainland could be an underestimated factor in the assembly of biotic communities in the region. Two detected increases of diversification rate occurred 3.13 and 1.19 Ma, which strongly implicated climatic rather than geological changes as likely drivers of diversification, with candidates being the Pliocene intensification of the East Asian monsoons, and Pleistocene climate and sea level fluctuations. Distribution modelling indicated that Pleistocene sea level and climate fluctuations were inferred to enable inter-island dispersal followed by allopatric separation, underpinning radiation in the genus. Overall, our study, based on multiple lines of evidence, linked plant diversification to the most recent climatic and geological events in SE Asia. We highlight the importance of immigration in the assembly and diversification of the SE Asian flora, and underscore the utility of plant clades, as independent lines of evidence, for reconstructing recent climatic and geological events in the SE Asian region.

Feasibility of continuous epidural analgesia in patients with failed back surgery syndrome and spinal stenosis.

PURPOSE: The purpose of this study was to outline the feasibility of continuous epidural analgesia in the treatment of failed back surgery syndrome (FBSS) or spinal stenosis. METHODS: We queried our prospective collected institutional database to include all consecutive patients, who underwent continuous epidural analgesia with accompanying intensive physiotherapeutic exercise within a timeframe of 4 years. Patients suffered from FBSS or spinal stenosis; protocolled continuous epidural analgesia was planned for 4 days within the framework of an inpatient multimodal pain therapy concept. The instillation technique of the epidural catheter, the capability to attend in accompanying physiotherapy, and the peri-interventional complications were evaluated. RESULTS: 153 patients with an average age of 57.4 years (± 11.9) were enrolled in this study. 105 patients suffered from FBSS and 48 patients had spinal stenosis. Overall, 148 patients (96.7%) reported the pain reduction and were able to perform daily intensified physiotherapeutic exercise. There were no serious adverse events, neither infection nor bleeding, no cardiopulmonary complication or permanent neurological deficits. The most common side effect was neurological impairment, such as numbness, dysesthesia, or weakness of the lower limbs with complete regression after flow rate adjustment. Patients with FBSS were more likely to develop dysesthesia (p = 0.007). CONCLUSIONS: Continuous epidural analgesia is feasible in patients with FBSS or spinal stenosis. This treatment enables extensive physiotherapeutic treatment even in patients with severe pain conditions and can be considered as an alternative to epidural injections. An increased complication rate in comparison to short-term perioperative or perinatal application was not observed.

Implementation of an anaemia walk-in clinic: Feasibility and preliminary data from the Orthopedic University Hospital.

BACKGROUND: Approximately one in three patients suffers from preoperative anaemia. Even though haemoglobin is measured before surgery, anaemia management is not implemented in every hospital. OBJECTIVE: Here, we demonstrate the implementation of an anaemia walk-in clinic at an Orthopedic University Hospital. To improve the diagnosis of iron deficiency (ID), we examined whether reticulocyte haemoglobin (Ret-He) could be a useful additional parameter. MATERIAL AND METHODS: In August 2019, an anaemia walk-in clinic was established. Between September and December 2019, major orthopaedic surgical patients were screened for preoperative anaemia. The primary endpoint was the incidence of preoperative anaemia. Secondary endpoints included Ret-He level, red blood cell (RBC) transfusion rate, in-hospital length of stay and anaemia at hospital discharge. RESULTS: A total of 104 patients were screened for anaemia. Preoperative anaemia rate was 20.6%. Intravenous iron was supplemented in 23 patients. Transfusion of RBC units per patient (1.7 ± 1.2 vs. 0.2 ± 0.9; p = 0.004) and hospital length of stay (13.1 ± 4.8 days vs. 10.6 ± 5.1 days; p = 0.068) was increased in anaemic patients compared to non-anaemic patients. Ret-He values were significantly lower in patients with ID anaemia (33.3 pg [28.6-40.2 pg]) compared to patients with ID (35.3 pg [28.9-38.6 pg]; p = 0.015) or patients without anaemia (35.4 pg [30.2-39.4 pg]; p = 0.001). CONCLUSION: Preoperative anaemia is common in orthopaedic patients. Our results proved the feasibility of an anaemia walk-in clinic to manage preoperative anaemia. Furthermore, our analysis supports the use of Ret-He as an additional parameter for the diagnosis of ID in surgical patients.

Anaesthetic care of patients undergoing primary hip and knee arthroplasty: consensus recommendations from the International Consensus on Anaesthesia-Related Outcomes after Surgery group (ICAROS) based on a systematic review and meta-analysis.

BACKGROUND: Evidence-based international expert consensus regarding anaesthetic practice in hip/knee arthroplasty surgery is needed for improved healthcare outcomes. METHODS: The International Consensus on Anaesthesia-Related Outcomes after Surgery group (ICAROS) systematic review, including randomised controlled and observational studies comparing neuraxial to general anaesthesia regarding major complications, including mortality, cardiac, pulmonary, gastrointestinal, renal, genitourinary, thromboembolic, neurological, infectious, and bleeding complications. Medline, PubMed, Embase, and Cochrane Library including Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, NHS Economic Evaluation Database, from 1946 to May 17, 2018 were queried. Meta-analysis and Grading of Recommendations Assessment, Development and Evaluation approach was utilised to assess evidence quality and to develop recommendations. RESULTS: The analysis of 94 studies revealed that neuraxial anaesthesia was associated with lower odds or no difference in virtually all reported complications, except for urinary retention. Excerpt of complications for neuraxial vs general anaesthesia in hip/knee arthroplasty, respectively: mortality odds ratio (OR): 0.67, 95% confidence interval (CI): 0.57-0.80/OR: 0.83, 95% CI: 0.60-1.15; pulmonary OR: 0.65, 95% CI: 0.52-0.80/OR: 0.69, 95% CI: 0.58-0.81; acute renal failure OR: 0.69, 95% CI: 0.59-0.81/OR: 0.73, 95% CI: 0.65-0.82; deep venous thrombosis OR: 0.52, 95% CI: 0.42-0.65/OR: 0.77, 95% CI: 0.64-0.93; infections OR: 0.73, 95% CI: 0.67-0.79/OR: 0.80, 95% CI: 0.76-0.85; and blood transfusion OR: 0.85, 95% CI: 0.82-0.89/OR: 0.84, 95% CI: 0.82-0.87. CONCLUSIONS: Recommendation: primary neuraxial anaesthesia is preferred for knee arthroplasty, given several positive postoperative outcome benefits; evidence level: low, weak recommendation. RECOMMENDATION: neuraxial anaesthesia is recommended for hip arthroplasty given associated outcome benefits; evidence level: moderate-low, strong recommendation. Based on current evidence, the consensus group recommends neuraxial over general anaesthesia for hip/knee arthroplasty. TRIAL REGISTRY NUMBER: PROSPERO CRD42018099935.

Needle tip tracking for ultrasound-guided peripheral nerve block procedures-An observer blinded, randomised, controlled, crossover study on a phantom model.

BACKGROUND: The Onvision needle tip tracking (NTT) is a new technology consisting of a needle with an ultrasound sensor close to the needle tip and a console for computerised signal processing. The aim of the study was to evaluate NTT technology during ultrasound-guided simulated peripheral nerve block procedures in a porcine phantom model. METHODS: Forty anaesthesiologists performed in-plane and out-of-plane simulated nerve blocks with and without NTT guidance. The primary outcome measure was procedure time. Secondary outcomes were hand movements and the path length travelled by the hands measured by motion analysis, precision of the needle tip related to the target structure, success rates and violations of the target structure, and the participants confidence whether their procedure would be successful or not. RESULTS: Procedure time was reduced from 66.7 (SD = 47.5) seconds to 43.8 (SD = 29.2) seconds when NTT was used for out-of-plane procedures (P = 0.002). The number of hand movements of the probe hand was 13.9 (SD = 30.2) with NTT and 22.8 (SD = 30.0) without NTT (P = 0.019). No significant differences were registered during the performance of in-plane procedures. The participants confidence in a presumed block success was increased with both in-plane procedures (8.50 (SD = 1.18) with NTT vs 7.65 (SD = 1.96), P = 0.004) and out-of-plane procedures (8.50 (SD = 1.09) vs 7.10 (SD = 1.89), P = 0.0001). CONCLUSIONS: The new NTT technology significantly reduced the procedure time and the number of hand movements for ultrasound-guided out-of-plane PNB procedures. No significant differences were found for the in-plane procedures.

[Ultrasound-Guided Regional Anaesthesia in Obesity]. / Ultraschallgesteuerte Regionalanästhesie bei Adipositas.

Obesity is associated with a number of anaesthesia-relevant risks. Regional anaesthesia procedures offer a number of advantages, but they also pose an anaesthetic challenge. For example, the identification of superficial landmarks according to the degree of obesity is difficult to impossible, which reduces the success rate compared to normal weight patients. The use of ultrasound (US) technology with the ability to visualize the target structures may be helpful in performing neuraxial and peripheral blockades. However, a lot of experience and training is required because the ultrasound imaging of very low-lying nerves in obese patients is limited due to the physical limitations of US technology.

Prolonged Catheter Use and Infection in Regional Anesthesia: A Retrospective Registry Analysis.

BACKGROUND: Prolonged catheter use is controversial because of the risk of catheter-related infection, but the extent to which the risk increases over time remains unknown. We thus assessed the time-dependence of catheter-related infection risk up to 15 days. METHODS: Our analysis was based on the German Network for Regional Anesthesia, which includes 25 centers. We considered 44,555 patients who had surgery between 2007 and 2014 and had continuous regional anesthesia as well as complete covariable details. Cox regression analysis was performed and adjusted for confounding covariables to examine the relationship between catheter duration and probability of infection-free catheter use. RESULTS: After adjustment for confounding factors, the probability of infection-free catheter use decreases with each day of peripheral and epidural catheter use. In peripheral catheters, it was 99% at day 4 of catheter duration, 96% at day 7, and 73% at day 15. In epidural catheters, it was 99% at day 4 of catheter duration, 95% at day 7, and 73% at day 15. Only 31 patients (0.07%) had severe infections that prompted surgical intervention. Among these were five catheters that initially had only mild or moderate signs of infection and were left in situ; all progressed to severe infections. CONCLUSIONS: Infection risk in catheter use increases over time, especially after four days. Infected catheters should be removed as soon as practical. VISUAL ABSTRACT: An online visual overview is available for this article at http://links.lww.com/ALN/B683.

Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis.

BACKGROUND: Ultrasound, nerve stimulation, and their combination are all considered acceptable ways to guide peripheral nerve blocks. Which approach is most effective and associated with the fewest complications is unknown. We therefore used a large registry to analyze whether there are differences in vascular punctures, multiple skin punctures, and unintended paresthesia. METHODS: Twenty-six thousand seven hundred and thirty-three cases were extracted from the 25-center German Network for Regional Anesthesia registry between 2007 and 2016 and grouped into ultrasound-guided puncture (n = 10,380), ultrasound combined with nerve stimulation (n=8173), and nerve stimulation alone (n = 8180). The primary outcomes of vascular puncture, multiple skin punctures, and unintended paresthesia during insertion were compared with conditional logistic regression after 1:1:1 propensity score matching. Results are presented as odds ratios and 95% CIs. RESULTS: Propensity matching successfully paired 2508 patients with ultrasound alone (24% of 10,380 patients), 2508 patients with a combination of ultrasound/nerve stimulation (31% of 8173 patients), and 2508 patients with nerve stimulation alone (31% of 8180 patients). After matching, no variable was imbalanced (standardized differences <0.1). Compared with ultrasound guidance alone, the odds of multiple skin punctures (2.2 [1.7-2.8]; P < .001) and vascular puncture (2.7 [1.6-4.5]; P < .001) were higher with nerve stimulation alone, and the odds for unintended paresthesia were lower with nerve stimulation alone (0.3 [0.1-0.7]; P = .03). The combined use of ultrasound/nerve stimulation showed higher odds of multiple skin punctures (1.5 [1.2-1.9]; P = .001) and lower odds of unintended paresthesia (0.4 [0.2-0.8]; P = .007) compared with ultrasound alone. Comparing the combined use of ultrasound/nerve stimulation with ultrasound alone, the odds for vascular puncture (1.3 [0.7-2.2]; P = .4) did not differ significantly. Systemic toxicity of local anesthetics was not observed in any patient with ultrasound guidance alone, in 1 patient with the combined use of ultrasound and nerve stimulation, and in 1 patient with nerve stimulation alone. CONCLUSIONS: Use of ultrasound alone reduced the odds of vascular and multiple skin punctures. However, the sole use of ultrasound increases the odds of paresthesia.

Single-dose Antibiotic Prophylaxis in Regional Anesthesia: A Retrospective Registry Analysis.

BACKGROUND: Catheter-related infection is a serious complication of continuous regional anesthesia. The authors tested the hypothesis that single-dose antibiotic prophylaxis is associated with a lower incidence of catheter-related infections. METHODS: Our analysis was based on cases in the 25-center German Network for Regional Anesthesia database recorded between 2007 and 2014. Forty thousand three hundred sixty-two surgical patients who had continuous regional anesthesia were grouped into no antibiotic prophylaxis (n = 15,965) and single-dose antibiotic prophylaxis (n = 24,397). Catheter-related infections in each group were compared with chi-square test after 1:1 propensity-score matching. Odds ratios (ORs [95% CI]) were calculated with logistic regression and adjusted for imbalanced variables (standardized difference more than 0.1). RESULTS: Propensity matching successfully paired 11,307 patients with single-dose antibiotic prophylaxis (46% of 24,397 patients) and with 11,307 controls (71% of 15,965 patients). For peripheral catheters, the incidence without antibiotics (2.4%) was greater than with antibiotic prophylaxis (1.1%, P < 0.001; adjusted OR, 2.02; 95% CI, 1.49 to 2.75, P < 0.001). Infections of epidural catheters were also more common without antibiotics (5.2%) than with antibiotics (3.1%, P < 0.001; adjusted OR, 1.94; 95% CI, 1.55 to 2.43, P < 0.001). CONCLUSIONS: Single-dose antibiotic prophylaxis was associated with fewer peripheral and epidural catheter infections.

Awake, sedated or anaesthetised for regional anaesthesia block placements?: A retrospective registry analysis of acute complications and patient satisfaction in adults.

BACKGROUND: Whether adults should be awake, sedated or anaesthetised during establishment of regional anaesthesia is still debated and there is little information on the relative safety of each. In paediatric practice, there is often little choice but to use sedation or anaesthesia as otherwise the procedures would be too distressing and patient movement would be hazardous. OBJECTIVE(S): The objective of this study was to evaluate complications related to central and peripheral regional block and patient satisfaction in awake, sedated and anaesthetised adult patients. DESIGN: A retrospective registry analysis. SETTING: The German Network of Regional Anaesthesia database was analysed between 2007 and 2012. PATIENTS: We included data of 42 654 patients and defined three groups: group I awake (n = 25 004), group II sedated (n = 15 121) and group III anaesthetised (n = 2529) for block placement. MAIN OUTCOME MEASURES: Odds ratios [OR; 95% confidence interval (CI)] were calculated with logistic regression analysis and adjusted for relevant confounders to determine the risk of block-related complications in sedated or anaesthetised patients compared with awake patients. RESULTS: Rates of local anaesthetic systemic toxicity were comparable between the groups [awake 0.02% (95% CI: 0.002 to 0.0375), sedated 0.02% (0.003 to 0.042) and anaesthetised 0% (0 to 0.12%)], as were the rates of pneumothorax [awake 0.035% (0 to 0.074), sedated 0% (0 to 0.002) and anaesthetised 0.2% (0 to 0.56)]. Considering peripheral nerve blocks, sedated patients had a decreased risk for multiple skin puncture [adjusted OR: 0.78 (95% CI: 0.71 to 0.85), premature termination [0.45 (0.22 to 0.91)], primary failure [0.58 (0.40 to 0.83)] and postoperative paraesthesia [0.35 (0.28 to 0.45)], but an increased risk for a bloody tap [1.82 (1.50 to 2.21)]. General anaesthesia increased the risk of a bloody tap [adjusted OR: 1.33 (95% CI: 1.01 to 1.78)] and multiple skin puncture [1.28 (1.12 to 1.46)], but decreased the risk for postoperative paraesthesia [0.16 (0.06 to 0.38)]. In neuraxial sites, sedation increased the risk for multiple skin puncture [adjusted OR: 1.18 (95% CI: 1.09 to 1.29)], whereas block placement under general anaesthesia decreased the risk for multiple skin puncture [0.53 (0.39 to 0.72)] and bloody tap but significantly increased the risk for postoperative paraesthesia related to a catheter [2.45 (1.19 to 5.02)]. Sedation was associated with a significant improvement in patient satisfaction. CONCLUSION: Sedation may improve safety and success of peripheral nerve block placement. Block placement under general anaesthesia in adults should be reserved for experienced anaesthesiologists and special situations.

[Selected medical closed claims in the field of regional anaesthesia]. / Gutachtenfälle - Gutachtenbeispiele aus der Regionalanästhesie.

Legal malpractice cases in regional anaesthesia comprise a significant number of all cases before the expert commissions and arbitration boards of the state medical associations. One reason for this is the increasing use of neuraxial and peripheral regional blocks in orthopaedics and traumatology. Only in about one fourth of the reviewed cases could either a causal relationship between substandard performance and patient injury or an inadequate obtaining of informed consent be established. In the great majority of cases patients' claims were unfounded, since the patients' injuries were adjudged to be unavoidable and adequate consent had been abtained prior to performance of the blocks.

[The Management of the Vertiginous Patient]. / Das Management des Schwindelpatienten.

In neuro-otology, history taking still represents the most important instrument. It comprises type, direction, duration, intensity and influencing factors of dizziness, vertigo and balance problems as well as accompanying symptoms of the otologic and neurologic systems. A distinction in a) acute persisting, b) episodic with or without positioning dependence and c) chronic vertigo can provide a first diagnostic differentiation. The clinical exam contains an otolaryngologic and neurologic assessment with focus on ocular motor function, nystagmus, head impulse testing, balance function tests, cerebellar signs and positioning tests. Helpful laboratory tests are tests of orthostatic function, pure tone audiometry, bithermal calorics, video head impulse test and in specific situations nystagmography and the recording of vestibular-evoked myogenic potentials. Often a brain magnetic resonance tomography needs to be added. In several cases a multi-disciplinary approach is recommended. Therapeutical options are physical therapy as vestibular rehabilitation or repositioning procedures, drugs or surgery, albeit the level of evidence of some therapies currently being applied is far from satisfactory.

Impact of vasodilators on diuretic response in patients with congestive heart failure: A mechanistic trial of cimlanod (BMS-986231).

AIM: To investigate the effects of Cimlanod, a nitroxyl donor with vasodilator properties, on water and salt excretion after an administration of an intravenos bolus of furosemide. METHODS AND RESULTS: In this randomized, double-blind, mechanistic, crossover trial, 21 patients with left ventricular ejection fraction <45%, increased plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and receiving loop diuretics were given, on separate study days, either an 8 h intravenous (IV) infusion of cimlanod (12 µg/kg/min) or placebo. Furosemide was given as a 40 mg IV bolus four hours after the start of infusion. The primary endpoint was urine volume in the 4 h after the bolus of furosemide during infusion of cimlanod compared with placebo. Median NT-proBNP at baseline was 1487 (interquartile range: 847-2665) ng/L. Infusion of cimlanod increased cardiac output and reduced blood pressure without affecting cardiac power index consistent with its vasodilator effects. Urine volume in the 4 h post-furosemide was lower with cimlanod (1032 ± 393 ml) versus placebo (1481 ± 560 ml) (p = 0.002), as were total sodium excretion (p = 0.004), fractional sodium excretion (p = 0.016), systolic blood pressure (p < 0.001), estimated glomerular filtration rate (p = 0.012), and haemoglobin (p = 0.010), an index of plasma volume expansion. CONCLUSIONS: For patients with heart failure and congestion, vasodilatation with agents such as cimlanod reduces the response to diuretic agents, which may offset any benefit from acute reductions in cardiac preload and afterload.

Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of upper and lower limb nerve blocks.

BACKGROUND: Inconsistent nomenclature and anatomical descriptions of regional anesthetic techniques hinder scientific communication and engender confusion; this in turn has implications for research, education and clinical implementation of regional anesthesia. Having produced standardized nomenclature for abdominal wall, paraspinal and chest wall regional anesthetic techniques, we aimed to similarly do so for upper and lower limb peripheral nerve blocks. METHODS: We performed a three-round Delphi international consensus study to generate standardized names and anatomical descriptions of upper and lower limb regional anesthetic techniques. A long list of names and anatomical description of blocks of upper and lower extremities was produced by the members of the steering committee. Subsequently, two rounds of anonymized voting and commenting were followed by a third virtual round table to secure consensus for items that remained outstanding after the first and second rounds. As with previous methodology, strong consensus was defined as ≥75% agreement and weak consensus as 50%-74% agreement. RESULTS: A total of 94, 91 and 65 collaborators participated in the first, second and third rounds, respectively. We achieved strong consensus for 38 names and 33 anatomical descriptions, and weak consensus for five anatomical descriptions. We agreed on a template for naming peripheral nerve blocks based on the name of the nerve and the anatomical location of the blockade and identified several areas for future research. CONCLUSIONS: We achieved consensus on nomenclature and anatomical descriptions of regional anesthetic techniques for upper and lower limb nerve blocks, and recommend using this framework in clinical and academic practice. This should improve research, teaching and learning of regional anesthesia to eventually improve patient care.

The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial.

BACKGROUND: A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood-brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention. METHODS/DESIGN: Two centers will include a total of 600 smokers who are motivated to quit smoking. At week -2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate. DISCUSSION: This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline) to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention. TRIAL REGISTRATION: ClinicalTrials.gov: (NCT00995033).

Vestibulo-ocular reflex gain improvements at peak head acceleration and velocity following onset of unilateral vestibular neuritis: Insights into neural compensation mechanisms.

BACKGROUND AND AIMS: An acute unilateral peripheral vestibular deficit (aUPVD) due to vestibular neuritis causes deficient yaw axis vestibular ocular reflex (VOR) gains. Using video head impulse tests (vHITs), we examined phasic and tonic velocity gains of the VOR over time to determine if these differed at onset and during subsequent improvement. METHODS: The VOR responses of 61 patients were examined within 5 days of aUPVD onset, and 3 and 7 weeks later using vHIT with mean peak yaw angular velocities of 177°/s (sd 45°/s) and mean peak accelerations of 3660°/s2 (sd 1300°/s2). The phasic velocity or acceleration gain (aG) was computed as the ratio of eye to head velocity around peak head acceleration, and the tonic velocity gain (vG) was calculated as the same ratio around peak head velocity. RESULTS: aG increased ipsi-deficit from 0.45 at onset to 0.67 at 3 weeks and 7 weeks later, and vG increased ipsi-deficit from 0.29 to 0.51 and 0.53, respectively, yielding a significant time effect (p < 0.001). Deficit side aG was significantly greater (p < 0.001) than vG at all time points. Deficit side gain improvements in aG and vG were similar. Contra-deficit aG increased from 0.86 to 0.95 and 0.94 at 3 weeks and 7 weeks, and vG contra-deficit increased from 0.84, to 0.89 and 0.87, respectively, also yielding a significant time effect (p = 0.004). Contra-deficit aG and vG were normal at 3 weeks. Mean canal paresis values improved from 91% to 67% over the 7 weeks. CONCLUSIONS: Acceleration and velocity VOR gains on the deficit side are reduced by aUPVD and improve most in the first 3 weeks after aUPVD onset. Deficit side aG is consistently higher than deficit side vG following an aUPVD, suggesting that acceleration rather than velocity sensitive compensatory neural mechanisms are predominant during the compensation process for aUPVD.

A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease.

BACKGROUND: Hyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. METHODS: In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR < 30 mL/min/1.73 m² and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH) levels. RESULTS: At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04). The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p < 0.001) and iPTH was significantly lower in the calcium acetate group compared to placebo (150 ± 157 vs. 351 ± 292 pg/mL respectively; p < 0.001). At 12 weeks, the proportions of subjects who had hypocalcemia were 5.4% and 19.5% for the calcium acetate and the placebo groups, respectively, while the proportions of those with hypercalcemia were 13.5% and 0%, respectively. Adverse events did not differ between the treatment groups. CONCLUSIONS: In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. TRIAL REGISTRATION: www.clinicaltrials.gov NCT00211978.

[The DGAI training module 3 in anaesthetic focussed sonography: neurosonography]. / DGAI-zertifizierte Seminarreihe Anästhesie Fokussierte Sonografie - Modul 3: Neurosonografie.

Identification of the right puncture site and the target structures are mandatory in performing nerve blocks. Ultrasound is a new method, that visualizes target structures as well as the injection and spread of local anaesthetic solution. The presented module 3 neurosonography is part of the didactic concept "anaesthesiology focussed sonography" developed by the german society of anaesthesiology and intensive care. It contains all essential nerve blocks of the upper and lower limb. Additionally the structural requirements to provide the course are included.