The experience of palliative work in a palliative consultancy service in Westfalen-Lippe / Das Erleben von Palliativarbeit in einem Palliativkonsiliardienst in Westfalen-Lippe.

THE EXPERIENCE OF PALLIATIVE WORK IN A PALLIATIVE CONSULTANCY SERVICE IN WESTFALEN-LIPPE: Background: In Westfalen-Lippe there has been a care concept for 8 years which does not insitutionalize general and specialized outpatient palliative care (AAPV and SAPV), which integrates the family doctor in a prominent position and orientates the service density to the changing needs of patients and their relatives (palliative medical consultancy service Iserlohn-Letmathe network, PKD NIL). The new Federal Framework Agreement (SAPV) emphasizes a nationwide, basically uniform structure in Germany. Existing regional structures are being put to the test. METHOD: Exploratory qualitative research was carried out. Using semi-structured, guided expert interviews, PKD NIL employees were asked how they experience their everyday work. Data from 17 people were evaluated. RESULTS: Teamwork and cooperation in the network are experienced positively by everyone working in the PKD NIL. The concept is based on the family doctor, holistic care is carried out. Cooperation with individual professional groups who are critical of the cooperation with the PKD NIL, cooperation with other PKDs, communication with relatives and those affected, the shortage of skilled workers, as well as the concern of upheaval due to the framework agreement on the SAPV in Germany are challenging. CONCLUSIONS: The research gives an insight into the experience of working in the PKD NIL. However, further studies are necessary in order to be able to make comparisons and to be able to assess whether improved palliative care can really be achieved in Germany.

[Fentanyl buccal tablets in the treatment of breakthrough cancer pain. German cohort of a pan-European multicentre study]. / Fentanyl-Buccaltabletten in der Behandlung von Durchbruchschmerzen : Deutsche Kohorte einer paneuropäischen multizentrischen Studie.

BACKGROUND: Patients with breakthrough cancer pain (BtCP) experience significant limitations in their physical, mental and social functions. Fentanyl buccal tablets (FBT), a rapid onset opioid, are specifically indicated for the treatment of BtCP. METHOD: The results of the German cohort of a pan-European study are presented. This included cancer pain patients from 32 German centers. Patients were on continuous opioid medication and had at least 4 BtCP episodes per day. After randomization to 2 groups, 66 patients started the titration of FBT with 100 µg (group A) and 200 µg (group B), respectively. All patients were titrated to their individual EAD, which could be a maximum of 800 µg FBT per episode, regardless of the initial dose. Subsequently, up to 8 BtCP episodes were treated with this EAD. At baseline and after treatment, patients assessed the effects of BtCP on their functional status using the modified BPI-7S and answered questions about the efficacy, simplicity, and ease-of-use of the treatment. RESULTS AND CONCLUSIONS: Successful titration was achieved by 49 patients (74.2%). There was no statistically significant difference between group A and group B. The global score of the modified BPI-7S increased by 8.5 (± 12.8) points (from 34.7 ± 13.6 at the beginning to 26.2 ± 15.8 at the end of treatment), from which a statistically significant improvement in the quality of life of patients can be derived. Global patient contentment improved, most notably the rapid onset of 2.4 points to 3.4 points at the end of the study. 76.9% of patients found taking FBT simple or very simple.

Postoperative Pain Trajectories and Pain Chronification-an Empirical Typology of Pain Patients.

Background: High intensity of acute postsurgical pain is one of the strongest predictors of chronic postsurgical pain (CPSP). We investigated if different types of patients with distinct combinations of initial pain intensity and rate of pain resolution exhibit different risks for increased pain intensity six months after surgery. Methods: Data from 174 patients were examined using growth mixture analysis by means of structural equation modeling. Results: Three types of patients were distinguished on the basis of acute pain trajectories. The majority of patients (57%) showed an unproblematic pattern of little initial pain on the first postoperative day, combined with further pain resolution over the four subsequent days. There also was a substantial group of patients (30%) who started out with severe pain but exhibited a high rate of pain resolution. Finally, we found a problematic group of patients (13%) who reported high pain intensities throughout all five postoperative measurements, with no signs of pain resolution. Even after controlling for preoperative pain intensity, these patients exhibited significantly higher pain intensities six months after surgery than the remaining patient groups. Conclusions: In this study, we demonstrated that there is substantial variation in postsurgical pain trajectories, not only with regard to postsurgical initial pain intensity, but also with regard to individual rates of pain resolution. Successful pain resolution appeared to be a better predictor of absence of increased pain intensities six months after surgery than initial pain immediately after surgery. Hence, attention should be given to appropriate pain treatment in order to minimize the risk of CPSP.

Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain.

CONTEXT: Prior Phase 2/3 studies found that cannabinoids might provide adjunctive analgesia in advanced cancer patients with uncontrolled pain. OBJECTIVES: To assess adjunctive nabiximols (Sativex®), an extract of Cannabis sativa containing two potentially therapeutic cannabinoids (Δ9-tetrahydrocannabinol [27 mg/mL] and cannabidiol [25 mg/mL]), in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. METHODS: Phase 3, double-blind, randomized, placebo-controlled trial in patients with advanced cancer and average pain Numerical Rating Scale scores ≥4 and ≤8 despite optimized opioid therapy. Patients randomized to nabiximols (n = 199) or placebo (n = 198) self-titrated study medications over a two-week period, followed by a three-week treatment period at the titrated dose. RESULTS: Median percent improvements in average pain Numerical Rating Scale score from baseline to end of treatment in the nabiximols and placebo groups were 10.7% vs. 4.5% (P = 0.0854) in the intention-to-treat population (primary variable) and 15.5% vs. 6.3% (P = 0.0378) in the per-protocol population. Nabiximols was statistically superior to placebo on two of three quality-of-life instruments at Week 3 and on all three at Week 5. In exploratory post hoc analyses, U.S. patients, but not patients from the rest of the world, experienced significant benefits from nabiximols on multiple secondary endpoints. Possible contributing factors to differences in nabiximols efficacy include: 1) the U.S. participants received lower doses of opioids at baseline than the rest of the world and 2) the subgroups had different distribution of cancer pain types, which may have been related to differences in pathophysiology of pain. The safety profile of nabiximols was consistent with earlier studies. CONCLUSIONS: Although not superior to placebo on the primary efficacy endpoint, nabiximols had benefits on multiple secondary endpoints, particularly in the U.S. PATIENTS: Nabiximols might have utility in patients with advanced cancer who receive a lower opioid dose, such as individuals with early intolerance to opioid therapy.

[Survey of family members, who's relatives were included in the palliative network Bielefeld e. V. and recently died]. / Befragung von Zugehörigen verstorbener Palliativpatienten in der ambulanten Versorgung des Palliativnetzes Bielefeld e. V.

BACKGROUND: The Palliative Network Bielefeld e. V. is a cooperation between family doctors and palliative care doctors based on the "agreement to implement palliative home care for terminally ill patients". The doctors are supported by coordinators, who regularly communicate with the patients resp. their family members and call in other co-operation partners (nursing services, ambulant hospice services, physiotherapists, psychologists or pastors) as required. METHOD: In order to collect data about the scope of services and the quality of work of the palliative network a questionnaire was sent to the family members 4 weeks after the patient had passed away. RESULTS: A total of 105 family members were asked, 94 completed questionnaires could be retrieved. 65% of the included patients died at home. Every other included patient had been taken care of for longer than a month. Of all professional groups who came into operation every day, nusring service and palliative nursing service were asked most frequently (52% resp. 41%), of those who came into operation several times a week, family doctors were asked most frequently (26%). 87% of the interviewees were "very content" or "content" with the coordinators, 73% resp. 74% with the family and palliative care doctors and 60% resp. with the nursing services and palliative nursing services. More than 90% of the interviewees stated that needs were realised and disorders were quickly acted on "at all times" or "predominantly". CONCLUSIONS: Correlations between the descriptive results could not be evaluated statistically because of sample size and incomplete frequency of answers. Nevertheless some trends can be shown. Overall contentment seems to increase as much as the percentage of patients who die at home and the duration of care in palliative network grow. The palliative network should be enhanced.

Is there a difference in postdural puncture headache after continuous spinal anesthesia with 28G microcatheters compared with punctures with 22G Quincke or Sprotte spinal needles?

In this retrospective study, the question was raised and answered whether the rate of postdural puncture headache (PDPH) after continuous spinal anesthesia with a 28G microcatheter varies using a Quincke or a Sprotte needle. The medical records of all patients with allogenic joint replacement of the knee or hip or arthroscopic surgery of the knee joint undergoing continuous spinal anesthesia with a 22G Quincke (n=1,212) or 22G Sprotte needle (n=377) and a 28G microcatheter during the past 6 years were reviewed. We obtained the approval of the ethical committee. The rates of PDPH were statistically not different between both groups: 1.5% of patients developed PDPH after dura puncture with a Quincke needle and 2.1% with a Sprotte needle in women and men.

Fixed ratio (2:1) prolonged-release oxycodone/naloxone combination improves bowel function in patients with moderate-to-severe pain and opioid-induced constipation refractory to at least two classes of laxatives.

OBJECTIVE: The effects of combined oxycodone/naloxone prolonged release tablets (OXN PR) were investigated in patients with moderate-to-severe chronic cancer-related or non-cancer pain. All patients had opioid-induced constipation (OIC) which persisted despite substantial laxative therapy. RESEARCH DESIGN AND METHODS: This pooled analysis included 75 patients with OIC at study entry that was refractory to at least two laxatives with different modes of action. Patients completed randomized, double-blind treatment with OXN PR 20-120 mg/day for either 12 weeks (OXN 9001: non-cancer pain study) or 4 weeks (OXN 2001: cancer-related pain study). Analgesia and bowel function were assessed using the Brief Pain Inventory Short Form and Bowel Function Index (BFI), respectively. Use of laxative medication and safety were assessed throughout the studies. CLINICAL TRIAL REGISTRATION: NCT00513656, EudraCT 2005-002398-57, EudraCT 2005-003510-15. RESULTS: Statistically and clinically significant improvements in bowel function were observed following double-blind treatment with OXN PR. Mean (SD) reduction in BFI score was 21.2 (28.8) and comparable in patients with cancer-related (19.0 [28.9]) and non-cancer pain (23.3.[29.0]; P ≤ 0.0002). Furthermore, the proportion of patients with a BFI score within normal range (≤28.8) increased from 9.5% at screening to 43.1% at Day 15 of OXN PR. While all patients used ≥2 laxatives of different classes at screening, during study treatment 36% stopped using laxatives (P < 0.001). OXN PR provided effective analgesia, evidenced by stable pain scores during study treatment, and there were no unanticipated adverse events. CONCLUSIONS: OXN PR significantly improved bowel function and reduced the use of laxatives in patients with OIC, previously unresponsive to at least two different classes of laxatives. OXN also provided effective analgesia for patients with moderate-to-severe cancer-related pain and non-cancer-related pain.

Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an established oxycodone twice daily prolonged release tablet.

OBJECTIVE: The first oxycodone once daily (OOD) has been developed and after successful pharmacokinetic characterization, therapeutic efficacy and safety were compared to an established oxycodone twice daily (OTD: Oxygesic/OxyContin, Mundipharma). DESIGN AND METHODS: A randomized, double-blind, multicenter, cross-over, non-inferiority study was conducted in patients (n = 68) with chronic malignant or non-malignant pain. The new OOD was compared to OTD at identical total daily doses (TDD: 40-120 mg/day) employing intensive, five times daily current pain (0-100 mm visual analog scale, VAS) and twice daily 12 h recalled pain assessments as well as safety parameters such as nausea and sedation (VAS) over 5 days for each treatment (after a 5 day run-in phase). RESULTS: There was no significant difference in analgesic potency detected between the two treatments based on 95% CI for difference in the daily mean current pain (-2.09 mm VAS) over 5 days, determined as -5.09 to 0.91 mm VAS. A difference ≤12 mm VAS indicated non-inferiority of OOD, i.e. lack of clinically relevant difference in analgesia. Intake of rescue medication had no effect on study results as evaluated by ANCOVA. The difference in adverse events (AEs) between the two treatments did not reach significance, as 19.1% and 23.5% of patients experienced treatment-related AEs while on OOD and OTD, respectively. Advantages for OOD regarding consistency of analgesia (i.e. use of rescue medication, current and recalled pain) and sedation did not reach statistical significance in this limited study population. CONCLUSION: Despite the small number of patients and short study duration, the results support the conclusion that new OOD is (at least) equivalent to established OTD regarding safety and efficacy.

Continuous spinal anesthesia for lower limb surgery: a retrospective analysis of 1212 cases.

BACKGROUND: Continuous spinal anesthesia is a very reliable and versatile technique for providing effective anesthesia and analgesia. However, the incidence of possible complications, including postdural puncture headache or neurological impairment, remains controversial. Therefore, the aim of the present retrospective study was to analyze a large number of patients for the incidence of adverse events after continuous spinal anesthesia with a microcatheter. METHODS: This retrospective study was conducted on 1212 patients who underwent surgery of the lower extremities with continuous spinal anesthesia, which was administered with 22-gauge Quincke spinal needles and 28-gauge microcatheters. Sociodemographic and clinical data were available from the patient records, and data on headaches and patient satisfaction were drawn from a brief postoperative patient questionnaire. RESULTS: The patient population included 825 females (68%) and 387 males; the median age was 61 (56-76). The types of operations performed were 843 hip prostheses, 264 knee prostheses, and 105 other leg operations. No major complications were observed in any of these patients. Tension headaches were experienced by 190 (15.7%) patients, but postdural puncture headaches were reported by only 18 (1.5%) patients. Nearly all patients (98.4%) were satisfied with continuous spinal anesthesia and confirmed that they would choose this kind of anesthesia again. CONCLUSION: Based on the findings of this large data analysis, continuous spinal anesthesia using a 28-gauge microcatheter appears to be a safe and appropriate anesthetic technique in lower leg surgery for aged patients.

Case report: successful treatment of a patient with trigeminal neuropathy using ziconotide.

A 50-year-old female patient with chronic neuropathic pain in the distribution of the second branch of the trigeminal nerve was unsuccessfully treated over several years. Intrathecal therapy with ziconotide was administered at an initial dose of 0.33 microg/d, which was gradually increased by 0.7 microg/d. Subjective pain on the numeric rating scale was reduced from 9/10 to 3-4/10 at a dose of 6.3 microg/d. Long-term treatment was continued at a ziconotide concentration of 12.5 microg/mL and a daily dose of 3.9 microg/d by a SynchroMed Infusion System (Medtronic, Minneapolis, MN). Pain reduction was maintained in the follow-up observation period over 5 months.

[Therapy of pain in multiborbid elderly patients]. / Schmerztherapie bei multimorbiden und betagten Patienten.

All human organ systems are prone to age-related physiological changes. Functional impairment is especially found in the liver, the kidneys, the nervous system, the gastrointestinal tract and the blood vessels. Changes in metabolism cause, e.g., changes in the composition of blood, reduction in neurotransmitters and the respective receptors, changes in calcium homeostasis with consequences for the stability of bones. As with any pharmacotherapy, the treatment of pain must consider these age-related factors. Adequate pain treatment is especially important in elderly patients, because the number of morbidities increases together with the number of pain conditions of different origin. In Germany, most patients with severe pain are undertreated. Although tumor pain, e.g., can be relieved in up to 95% of patients, up to 40% of patients under medical treatment still have pain, the German Pain League states. The WHO's pain ladder, developed in the 1980ies, is still regarded as an appropriate guideline, albeit too often disregarded by physicians, reflecting the reserve of patients and doctors towards opioids. With progress in opioid therapy, however, experts tend to early prescription of step-III-analgesics without sticking to the steps of the WHO ladder. Constipation, the major side effect of opioids, can be overcome by co-medication with laxatives. The combination of slow-release oxycodone with naloxone, an orally given antagonist of intestinal micro-receptors is effective as analgesic and maintains the normal bowel function.