A prospective case series of sphenopalatine ganglion pulsed radiofrequency therapy for refractory chronic cluster headache.

BACKGROUND AND PURPOSE: The management options for chronic cluster headache (CCH) are limited and a significant proportion of patients become refractory to pharmacological treatments. Pulsed radiofrequency (PRF) of the sphenopalatine ganglion (SPG) may present an efficacious, minimally invasive treatment modality for patients with refractory CCH. We describe the clinical outcomes of 14 patients with refractory CCH treated with PRF of the SPG. METHODS: Patients with medically refractory CCH who underwent percutaneous SPG-PRF treatment between January 2016 and April 2019 were included in this report. Patients obtaining at least 30% reduction in weekly cluster attacks for at least 3 months were defined as responders. Treatment-related side effects were collected. RESULTS: A total of 14 patients were included in this report (nine males). At a median follow-up of 6.5 (range 6-13) months post-procedure, eight patients (57.1%) were defined as responders to the treatment. Six patients were non-responders and reported either a reduction in frequency and severity of attacks for <3 months (2/6), no improvement (2/6) or temporary worsening of symptoms (1/6). The majority of patients (63.6%, n = 7/11) treated with >45 V were responders compared with responders treated with 45 V (33.3%, n = 1/3). Five patients (35.7%) experienced post-procedural side effects. CONCLUSION: This case series suggests that PRF targeting the SPG might offer a safe, minimally invasive and effective treatment for medically refractory CCH. Given the small number of cases and the short follow-up, larger and more robust studies will be needed to confirm our findings.

Prospective real-world analysis of OnabotulinumtoxinA in chronic migraine post-National Institute for Health and Care Excellence UK technology appraisal.

BACKGROUND AND PURPOSE: The National Institute for Health and Care Excellence (NICE) in the UK recommends the use of OnabotulinumtoxinA (BoNTA, Botox® ) in the management of chronic migraine (CM) following specific guidelines within the National Health Service. In view of the lack of data on the efficacy of this therapy following implementation of these guidelines in clinical practice and on the evaluation of guidance compliance, we aimed to evaluate the effectiveness and safety of BoNTA in patients with CM following the NICE guidelines. METHODS: This was a prospective real-life audit study. RESULTS: After two treatments, 127 of 200 patients (63.5%) obtained at least a 30% reduction in headache days. Those who continued the treatment up to 3 years reported a stable beneficial effect compared with baseline. Amongst responders, 68 patients (53.5%) were reclassified as episodic migraineurs. A total of 57 of these patients (83.8%) converted to an episodic migraine pattern at 6-month follow-up. The majority of those whose migraine became episodic after BoNTA extended the treatment intervals beyond 3 months (range 4-8 months) before noticing any worsening of headache. We observed no significant differences in the efficacy measures in patients treated with 155 U BoNTA compared with those treated with >155 U BoNTA. CONCLUSIONS: When administered according to the NICE guidance, BoNTA produced a clinically meaningful effect in the long-term management of CM with and without medication overuse headache. Treatment discontinuation when CM becomes episodic may be useful in clinical practice to identify those who may benefit from extended treatment intervals. Our clinical experience indicates a lack of additional benefit from using the 'follow-the-pain' paradigm.

Changes in cerebrospinal fluid magnesium levels in patients undergoing spinal anaesthesia for hip arthroplasty: does intravenous infusion of magnesium sulphate make any difference? A prospective, randomized, controlled study.

BACKGROUND: Most investigators have attributed the reduced postoperative pain or anaesthetic drug requirements in patients receiving i.v. magnesium sulphate (MgSO(4)) infusion during spinal or general anaesthesia to central N-methyl-d-aspartate (NMDA) receptor magnesium (Mg) activity. In this study, we investigated how cerebrospinal fluid (CSF) Mg concentrations change after spinal anaesthesia, and whether peripherally infusing MgSO(4) influences central Mg levels. METHODS: Forty-five patients undergoing continuous spinal anaesthesia for hip arthroplasty were randomly assigned to receive either i.v. MgSO(4) at a dose of 50 mg kg(-1) diluted in 100 ml 0.9% saline solution followed by 15 mg kg(-1) h(-1) for 6 h or saline at the same volume [mean (sd) 64 (10) ml]. The changes in CSF and serum total and ionized Mg concentrations were assessed at six time points before and after spinal anaesthesia. Secondary outcome variables included serum and CSF electrolytes and proteins. RESULTS: Thirty-five patients completed the study. We found that spinal anaesthesia reduced total and ionized Mg concentrations in CSF by about 10%. Increasing serum Mg concentration over 80% of the baseline value left CSF Mg levels unchanged. CONCLUSIONS: Spinal anaesthesia unexpectedly reduced CSF total and ionized Mg concentrations in patients undergoing hip arthroplasty, although the mechanism is unclear. The dose used for peripheral MgSO(4) infusion in this study had no influence on central Mg concentrations in neurologically healthy patients undergoing spinal anaesthesia. If CSF Mg concentration is a reliable marker of Mg brain bioavailability, peripherally infused MgSO(4) during spinal anaesthesia is unlikely to influence central NMDA receptor activity.

Tetraplegia following parathyroidectomy in two long-term haemodialysis patients.

We report two cases of postoperative iatrogenic tetraparesis, which occurred in different hospitals after surgery for parathyroidectomy. Both patients were on long-term haemodialysis. The prolonged neck extension usually required by this procedure was probably the main factor involved in the genesis of the spinal cord injury. Spinal abnormalities associated with chronic renal failure may have made these patients more vulnerable. In our opinion, it is advisable to investigate thoroughly any sign of spinal stenosis in patients who undergo any procedure requiring significant neck extension, particularly if on long-term haemodialysis.

Effects of remifentanil-based general anaesthesia with propofol or sevoflurane on muscle microcirculation as assessed by near-infrared spectroscopy.

BACKGROUND: Although anaesthetics are known to alter microcirculation no study has, to our knowledge, documented changes in human skeletal microcirculatory function during general anaesthesia. METHODS: Forty-four patients undergoing maxillofacial surgery at a university hospital were prospectively randomized to receive general anaesthesia with remifentanil combined with propofol or sevoflurane. Muscle microcirculation was investigated with near-infrared spectroscopy (NIRS) before general anaesthesia was induced and 30 min later. An NIRS device (NIMO, Nirox) was used to quantify calf deoxyhaemoglobin [HHb], oxyhaemoglobin [HbO2], and total haemoglobin [HbT] concentrations, coupled to a series of venous and arterial occlusions to measure calf blood flow, muscle oxygen consumption, calf vascular resistance, microvascular compliance, and haemoglobin resaturation rate (RR). RESULTS: In both the groups, general anaesthesia induced marked changes in muscle microcirculation: the tissue blood volume increased (+33% in remifentanil-sevoflurane and +45% with remifentanil-propofol groups), microvascular resistance decreased (-31% and -38%, respectively), and the post-ischaemic haemoglobin RR decreased (-48% and -36%, respectively). In the remifentanil-propofol group, the muscle blood flow increased (P<0.001), whereas in the remifentanil-sevoflurane group microvascular compliance and muscle oxygen consumption decreased (P<0.01). CONCLUSIONS: Remifentanil-based general anaesthesia with propofol or sevoflurane altered the muscle microcirculation in different ways. Quantitative NIRS, a technique that takes into account the optical tissue properties of the individual subject, can effectively measure these changes non-invasively.

Ropivacaine and levobupivacaine for bilateral selective ankle block in patients undergoing hallux valgus repair.

BACKGROUND: A selective ankle block, blocking the tibial, deep and superficial peroneal nerves, can be used successfully for great toe surgery. No comparative information is available on selective ankle block using ropivacaine and levobupivacaine. METHODS: We compared the onset time and success rate of a selective ankle block using low volumes (12 ml) of ropivacaine 10 mg/ml and levobupivacaine 7.5 mg/ml in 40 patients undergoing elective repair of bilateral hallux valgus. Each patient received an ankle block induced in one foot with ropivacaine and in the contralateral foot with levobupivacaine. RESULTS: The success rate was higher [90% vs. 75%, hazard ratio (95% CI) 0.39 (0.23-0.64)] and anesthesia onset time was shorter (median, 10 vs. 20 min) after ropivacaine than after levobupivacaine. In successful ankle blocks, post-operative pain was similar in the two groups. CONCLUSION: In this study, ropivacaine 10 mg/ml had a shorter anesthesia onset time and a higher success rate than levobupivacaine 7.5 mg/ml for selective ankle block.

Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: A prospective, open-label, exploratory study.

BACKGROUND: A significant minority of chronic migraine (CM) subjects fail conventional medical treatment (rCM), becoming highly disabled. Implantation of an occipital nerve stimulator is a therapeutic option for these subjects. Paresthesia-free cervical 10 kHz spinal cord stimulation (HF10 SCS) may provide an alternative. We report the results of a prospective, open-label, exploratory study assessing the long-term safety, tolerability and efficacy of cervical HF10 SCS in cohort of rCM subjects. METHODS: Included subjects were diagnosed with CM by an experienced headache specialist with the aid of an hourly headache diary. They were refractory to conventional medical treatments including onabotulinumtoxin-A injections. Medication overuse headache was not an exclusion criteria. Enrolled subjects underwent a 2- to 4-week tunnelled cervical HF10 SCS trial followed by a permanent system implant if a significant, subjective reduction in headache intensity/episodes was reported during the trial. Subjects were evaluated at baseline and 6 months after implantation with the aid of monthly diaries and headache-specific questionnaires. RESULTS: Seventeen subjects underwent a trial of cervical HF10 SCS; 14 were still implanted at 6 months (one trial failure, one trial infection, one implant site infection). Seven of the 14 subjects had >30% reduction in headache days. The average reduction in headache days was 6.9 for the overall population and 12.9 among the responders. Three subjects reported tenderness over the IPG/connection site, and one had a lead migration that required surgical revision. CONCLUSION: Paresthesia-free cervical HF10 SCS may be a safe and effective therapeutic option for chronic migraineurs refractory to conventional treatments.

Effects of sternotomy on heart-lung interaction in patients undergoing cardiac surgery receiving pressure-controlled mechanical ventilation.

BACKGROUND: The key concept underlying the dynamic indexes of preload dependence is the physiological heart-lung interaction. During sternotomy this interaction undergoes various changes, some of which remain unclear. Our primary aim was to investigate how the interaction changes during sternotomy by evaluating pulse pressure variations (PPV) with the chest closed and after sternotomy in patients ventilated using the pressure-controlled mode. METHODS: We prospectively studied 25 patients undergoing coronary artery bypass grafting (CABG) receiving pressure-controlled ventilation. Standard hemodynamic data, PPV and tidal volume delivered were recorded before and after sternotomy, and, with the chest open, before and after positive end-expiratory pressure (PEEP) was applied and inspiratory pressure was increased. RESULTS: Sternotomy left all variables statistically unchanged from values before thoracotomy although in the subgroup of patients with a PPV > 8% (56%) sternotomy significantly reduced PPV (from 14.4 +/- 5.2% to 8.9 +/- 4.5%). With the chest open, when PEEP was applied at 5 cm H(2)O, tidal volume decreased (from 643 +/- 83 to 587 +/- 104 ml) and stroke volume decreased (from 77 +/- 17 to 72 +/- 15 ml) but PPV remained unchanged. When PEEP was discontinued and inspiratory pressure was increased by 5 cm H(2)O, tidal volume increased (from 643 +/- 83 to 814 +/- 89 ml) and PPV increased (from 8.2 +/- 3.9% to 12.3 +/- 6.8%) but stroke volume remained unchanged. CONCLUSIONS: In patients ventilated in the pressure-controlled mode, except those with a pre-sternotomy PPV > 8% (fluid responders), sternotomy leaves standard hemodynamic data and PPV unchanged. When the chest wall is open, cyclic changes (tidal volume) but not continuous changes (PEEP) in intrathoracic pressure directly influence PPV.

Combined intrathecal and epidural magnesium sulfate supplementation of spinal anesthesia to reduce post-operative analgesic requirements: a prospective, randomized, double-blind, controlled trial in patients undergoing major orthopedic surgery.

BACKGROUND: New ways of decreasing post-operative analgesic drug requirements are of special interest after major surgery. Magnesium sulfate (MgSO(4)) alters pain processing and reduces the induction and maintenance of central sensitization by blocking the N-methyl-D-aspartate (NMDA) receptor in the spinal cord. We investigated whether supplementation of spinal anesthesia with combined intrathecally and epidurally infused MgSO(4) reduced patients' post-operative analgesia requirements. METHODS: In a randomized, prospective, double-blind, placebo-controlled trial, we enrolled 120 consecutive patients undergoing orthopedic surgery during spinal anesthesia (levobupivacaine and sufentanil). Patients were randomly assigned to receive intrathecal MgSO(4) (94.5 mg, 6.3%), epidural MgSO(4) (2%, 100 mg/h), intrathecal and epidural MgSO(4) combined or spinal anesthesia alone (controls). Post-operative morphine consumption was assessed in all groups by patient-controlled analgesia (PCA). RESULTS: Of the 120 patients enrolled, 103 (86%) completed the study. Morphine consumption at 36 h after surgery was 38% lower in patients receiving spinal anesthesia plus epidural MgSO(4) [- 14.963 mg; 95% confidence interval (CI), - 1.44 to - 28.49 mg], 49% lower in those receiving spinal anesthesia plus intrathecal MgSO(4) (- 18.963 mg; 95% CI, - 5.27 to - 32.65 mg) and 69% lower in the intrathecal-epidural combined group (- 26.963 mg; 95% CI, - 13.73 to - 40.19 mg) relative to control patients receiving spinal anesthesia alone. No complications developed during the post-operative course or at 1 month after surgery. CONCLUSION: In patients undergoing orthopedic surgery, supplementation of spinal anesthesia with combined intrathecal and epidural MgSO(4) significantly reduces patients' post-operative analgesic requirements.

Lateral popliteal sciatic nerve block: a single injection targeting the tibial branch of the sciatic nerve is as effective as a double-injection technique.

BACKGROUND: Evidence indicating that single- and double-injection techniques for inducing a sciatic nerve block via a posterior subgluteal approach yield a similar success rate prompted us to investigate whether the two anesthetic techniques yield a similar success rate via a lateral approach. We also hypothesized that, owing to the peculiar anatomic features of the sciatic nerve at the popliteal level, a single injection via the lateral approach might induce effective anesthesia by targeting the tibial nerve only. METHODS: Ninety-six patients undergoing popliteal sciatic nerve block via a lateral popliteal approach for foot surgery were randomized to receive a single 30-ml injection of ropivacaine 7.5 mg/ml to block the tibial nerve (TN group, n= 32) or the common peroneal nerve (CPN group, n= 32), or two separate 15-ml injections (TN + CPN group, n= 32), after stimulation to evoke motor responses from the target nerves. RESULTS: The mean time to obtain a complete sensory blockade (surgical anesthesia) was shorter in the TN group than in the CPN and TN + CPN groups (14 +/- 7 min vs. 23 +/- 17 and 21 +/- 14 min, respectively; P < 0.05). The success rate was similar in the TN and TN + CPN groups (94%) and, 25 min after the initial injection, was already better in these groups than in the CPN group (94% vs. 75%; P < 0.05). CONCLUSIONS: A lateral popliteal sciatic nerve block obtained with a single 30-ml injection of ropivacaine 7.5 mg/ml after electrostimulation to locate the tibial nerve is as effective as multiple TN + CPN stimulation and injection, and local anesthesia has a significantly shorter onset time.

The "To Err is Human" report and the patient safety literature.

BACKGROUND: The "To Err is Human" report published by the Institute of Medicine (IOM) in 1999 called for a national effort to make health care safer. Although the report has been widely credited with spawning efforts to study and improve safety in health care, there has been limited objective assessment of its impact. We evaluated the effects of the IOM report on patient safety publications and research awards. METHODS: We searched MEDLINE to identify English language articles on patient safety and medical errors published between 1 November 1994 and 1 November 2004. Using interrupted time series analyses, changes in the number, type, and subject matter of patient safety publications were measured. We also examined federal (US only) funding of patient safety research awards for the fiscal years 1995-2004. RESULTS: A total of 5514 articles on patient safety and medical errors were published during the 10 year study period. The rate of patient safety publications increased from 59 to 164 articles per 100,000 MEDLINE publications (p<0.001) following the release of the IOM report. Increased rates of publication were observed for all types of patient safety articles. Publications of original research increased from an average of 24 to 41 articles per 100,000 MEDLINE publications after the release of the report (p<0.001), while patient safety research awards increased from 5 to 141 awards per 100,000 federally funded biomedical research awards (p<0.001). The most frequent subject of patient safety publications before the IOM report was malpractice (6% v 2%, p<0.001) while organizational culture was the most frequent subject (1% v 5%, p<0.001) after publication of the report. CONCLUSIONS: Publication of the report "To Err is Human" was associated with an increased number of patient safety publications and research awards. The report appears to have stimulated research and discussion about patient safety issues, but whether this will translate into safer patient care remains unknown.