Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience.

Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming (i.e., combination therapy) at 16 in Europe. Following implantation, patients were provided with an array of advanced supra-perception programs (e.g., paresthesia-based SCS using multiple independent current sources), and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months (n = 117) and at 12 months post-implant (n = 90), respectively (p < 0.0001). Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed (n = 60). These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain.

Intrathecal pain management with ziconotide: Time for consensus?

This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence-based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the European marketing authorization for ziconotide, hosted the meeting. The group agreed that ITA is under-used in Europe, adding that ziconotide ITA has potential to be a first-line alternative to morphine; both are already first-line options in the USA. Ziconotide ITA (initiated using a low-dose, slow-titration approach) is suitable for many patients with noncancer- or cancer-related chronic refractory pain and no history of psychosis. Adopting ziconotide as first-line ITA could reduce opioid usage in these patient populations. The group advocated a risk-reduction strategy for all candidate patients, including compulsory prescreening for neuropsychosis, and requested US-European alignment of the licensed starting dose for ziconotide: the low-and-slow approach practiced in the USA has a better tolerability profile than the fixed high starting dose licensed in Europe. Of note, an update to the European Summary of Product Characteristics is anticipated in early 2021. The group acknowledged that the Polyanalgesic Consensus Conference (PACC) treatment algorithms for ziconotide ITA provide useful guidance, but recommendations tailored specifically for European settings are required. Before a consensus process can formally begin, the group called for additional European prospective studies to investigate ziconotide in low-and-slow dosing strategies, in different patient settings. Such data would enable European guidance to have the most appropriate evidence at its core.

Airway management in anesthesia for thoracic surgery: a "real life" observational study.

BACKGROUND: One-lung ventilation (OLV) in thoracic anesthesia is required to provide good surgical exposure. OLV is commonly achieved through a double lumen tube (DLT) or a bronchial blocker (BB). Malposition is a relevant issue related to these devices use. No prospective studies with adequately large sample size have been performed to evaluate the malposition rate of DLTs and BBs. METHODS: A total of 2,127 patients requiring OLV during thoracic surgery were enrolled. The aim of this multicenter prospective observational study performed across 26 academic and community hospitals is to evaluate intraoperative malposition rate of DLTs and BBs. We also aim to assess: which device is the most used to achieve OLV, the frequency of bronchoscope (BRO) use, the incidence rate of desaturation during OLV and the role of other factors that can correlate to this event, and incidence of difficult airway. RESULTS: Malposition rate for DLTs was 14%, for BBs 33%. DLTs were used in 95% of patients and BBs in 5%. Mean positioning time was shorter for DLT than BB (156±230 vs. 321±290 s). BRO was used in 54% of patients to check the correct positioning of the DLT. Desaturation occurred in 20% of all cases during OLV achieved through a DLT. Predicting factors of desaturation were dislocation (OR 2.03) and big size of DLT (OR 1.15). BRO use (OR 0.69) and left surgical side (OR 0.41) proved to be protective factors. Difficult airway prevalence was 16%; 10.8% predicted and 5.2% unpredicted. CONCLUSIONS: DLT has a low malpositioning rate and is the preferred device to achieve OLV. BRO use recorded was unexpectedly low. The possibility of encountering a difficult airway is frequent, with an overall prevalence of 16%. Risk factors of desaturation are malposition and increased size of DLT. Left procedures and BRO use could lead to fewer episodes of desaturation.

Treatment of painful osteoporotic or traumatic vertebral compression fractures by percutaneous vertebral augmentation procedures: a nonrandomized comparison between vertebroplasty and kyphoplasty.

OBJECTIVE: Vertebroplasty (PV) and balloon kyphoplasty (KP) are minimally invasive vertebral augmentation procedures involving injection of polymethyl methacrylate cement under radiologic control into a fractured vertebral body. They strengthen the bone and improve the intense pain caused by fracture secondary to osteoporosis, metastasis, or trauma and refractory to conservative therapies such as analgesic use, bed rest, and bracing. Aim of the study is to investigate and compare safety and efficacy of KP and PV on pain and mobility in patients with vertebral fractures due to osteoporosis or trauma. METHODS: Twenty-one patients have been enrolled in a prospective nonrandomized controlled study with painful vertebral compression fractures resistant to common therapies. Patients underwent KP or PV. A Visual Analog Scale has been used to measure pain status at different time up to 6 months; the Oswestry Disability Index (ODI) was chosen to evaluate functional activity before procedure and 6 months later. RESULTS: Mean pain scores decreased significantly from pretreatment to posttreatment with KP and PV as did the ODI scores. No significant differences could be found between both groups for the mean VAS and ODI scores preprocedure and postprocedure. Cement extravasation occurred only during PV. No other adverse events correlated to both techniques have been reported. DISCUSSION: Our results suggest that both PV and KP offer therapeutic benefit significantly reducing pain and improving mobility in patients with vertebral fracture without significant differences between groups in term of quality. The leakage of cement has been observed only during PV.

New local anesthetics for pediatric anesthesia.

PURPOSE OF REVIEW: To evaluate the relevance of new local anesthetics in pediatric regional anesthesia. RECENT FINDINGS: Several studies evaluate the pharmacokinetics of new local anesthetics, like ropivacaine and levobupivacaine, and compare their safety and efficacy with the old but widely used bupivacaine. SUMMARY: The goal of anesthetists using regional anesthesia is to use local anesthestics that are as safe and effective as possible, with a rapid onset and a long duration. Even though adequate dose guidelines are available, several toxic effects are reported with the use of bupivacaine in children due to inadvertent intravenous injection, long-term infusion (> 48 h) or administration in newborn babies and infants with reduced metabolism. Ropivacaine and levobupivacaine are new local anesthetics with a wider safety margin that have similar characteristics: both of them are pure S-(-)-enantiomers whose main pharmacological features are less cardio- and neuro-affinity and -toxicity in comparison with the racemic formulae and R-isomers, and a differential neural blockade with less motor than sensory block. Several clinical studies in children compare ropivacaine and levobupivacaine with bupivacaine.

A comparison of epidural bupivacaine, levobupivacaine, and ropivacaine on postoperative analgesia and motor blockade.

In this prospective, randomized, observer-blinded clinical trial, we compared the incidence of unwanted lower extremity motor blockade and the analgesic efficacy between small-dose (0.125%; 0.2 mg x kg(-1) x h(-1)) postoperative epidural infusions of bupivacaine (Group B; n = 28), levobupivacaine (Group L; n = 27), and ropivacaine (Group R; n = 26) in children after hypospadias repair. Motor blockade and pain were assessed at predetermined time points during 48 h by using a modified Bromage scale and the Children's and Infant's Postoperative Pain Scale (CHIPPS). Postoperative analgesia was almost identical in all three study groups (CHIPPS range, 0-3), with no need for the administration of supplemental analgesia in any patient. However, significantly more patients in Group B (n = 6; P = 0.03) displayed signs of unwanted motor blockade during the observation period compared with Group L (n = 0) and Group R (n = 0). In conclusion, significantly less unwanted motor blockade was associated with postoperative epidural infusions of 0.125% levobupivacaine or ropivacaine in children after hypospadias repair as compared with a similar infusion of bupivacaine. However, no difference with regard to postoperative analgesia could be detected among the three different local anesthetics studied.

A comparison of three different concentrations of levobupivacaine for caudal block in children.

UNLABELLED: We investigated three different concentrations of levobupivacaine (0.125%, 0.20%, and 0.25%; n = 20 in each group) for caudal blockade in a prospective, randomized, observer-blinded fashion in children (1-7 yr) undergoing subumbilical surgery. The duration of postoperative analgesia was assessed as the time to first administration of supplemental analgesia (based on a Childrens and Infants Postoperative Pain Scale score of >or=4), and the degree of immediate postoperative motor blockade was determined by use of a 3-point scale. A dose-response relationship was observed both with regard to median duration of postoperative analgesia (0.125%, 60 min; 0.20%, 118 min; 0.25%, 158 min) and the number of patients with evidence of early postoperative motor blockade (0.125%, 0; 0.20%, 4; 0.25%, 8). The 0.125% concentration was associated with significantly less early motor blockade (P = 0.003) but was found to result in a significantly shorter duration of postoperative analgesia (P < 0.05). Based on these results, the use of 0.20% levobupivacaine might represent the best clinical option if a plain levobupivacaine solution is to be used for caudal blockade in children. IMPLICATIONS: The use of 0.125% levobupivacaine for caudal blockade (1 mL/kg) in children (1-7 yr) was associated with less early postoperative motor blockade but a shorter duration of postoperative analgesia compared with 0.20% and 0.25% solutions.

Management of postoperative nausea and vomiting in children.

In spite of improvements in anesthesia techniques, the 'big little problem' of postoperative nausea and vomiting (PONV) still exists. PONV can prolong recovery room stay and hospitalization, and is one of the most common causes of hospital readmission after day surgery. While there is little evidence to support prophylactic administration of antiemetics in patients at low risk of PONV, the higher risk population could benefit from the use of adequate antiemetic drugs. A wide variety of pharmacological approaches have been reported to be effective, as well as some nonpharmacological approaches. Antiemetic drugs available to treat or prevent PONV include phenothiazines, antihistamines, anticholinergics, benzamides, butyrophenones and 5-HT(3) antagonists. Since available drugs still present undesired adverse effects and are not completely able to control PONV, clinical investigations are ongoing for more effective and better tolerated agents; indeed, the ideal antiemetic drug might be cost-effective for routine use.