Association of Perioperative Regional Analgesia with Postoperative Patient-Reported Pain Outcomes and Opioid Requirements: Comparing 22 Different Surgical Groups in 23,911 Patients from the QUIPS Registry.

(1) Background: In many surgical procedures, regional analgesia (RA) techniques are associated with improved postoperative analgesia compared to systemic pain treatment. As continuous RA requires time and experienced staff, it would be helpful to identify settings in which continuous RA has the largest benefit. (2) Methods: On the basis of 23,911 data sets from 179 German and Austrian hospitals, we analyzed the association of perioperative RA with patient-reported pain intensity, functional impairment of movement, nausea and opioid use for different surgeries. Regression analyses adjusted for age, sex and preoperative pain were performed for each surgery and the following groups: patients receiving continuous RA (surgery and ward; RA++), RA for surgery only (RA+-) and patients receiving no RA (RA--). (3) Results: Lower pain scores in the RA++ compared to the RA-- group were observed in 13 out of 22 surgeries. There was no surgery where pain scores for RA++ were higher than for RA--. If maximal pain, function and side effects were combined, the largest benefit of continuous RA (RA++) was observed in laparoscopic colon and sigmoid surgery, ankle joint arthrodesis, revision (but not primary) surgery of hip replacement, open nephrectomy and shoulder surgery. The benefit of RA+- was lower than that of RA++. (4) Discussion: The additional benefit of RA for the mentioned surgeries is larger than in many other surgeries in clinical routine. The decision to use RA in a given surgery should be based on the expected pain intensity without RA and its additional benefits.

Treatment of spinal anaesthesia-induced hypotension with cafedrine/theodrenaline versus ephedrine during caesarean section: Results from HYPOTENS, a national, multicentre, prospective, noninterventional study.

BACKGROUND: In Germany, hypotension induced by spinal anaesthesia is commonly treated with a combination of cafedrine hydrochloride (C, 200 mg) and theodrenaline hydrochloride (T, 10 mg) in 2 ml. We compared the effectiveness of C/T with ephedrine. OBJECTIVES: The primary objectives were to assess the speed of onset and the ability to restore blood pressure without an increase in heart rate. Secondary objectives were to evaluate maternal/foetal outcomes and the number of required additional boluses or other additional measures. DESIGN: HYPOTENS was a national, multicentre, prospective, open-label, two-armed, noninterventional study comparing C/T with ephedrine in two prospectively defined cohorts. This study relates to the cohort of patients receiving spinal anaesthesia for caesarean section. SETTING: German hospitals using either C/T or ephedrine in their routine clinical practice. PATIENTS: Women aged at least 18 years receiving spinal anaesthesia for caesarean section. INTERVENTIONS: Bolus administration of C/T or ephedrine at the discretion of the attending anaesthesiologist. MAIN OUTCOME MEASURES: Endpoints within 15 min after initial administration of C/T or ephedrine were area under the curve between the observed SBP and the minimum target SBP; and incidence of newly occurring heart rate of at least 100 beats min-1. RESULTS: Although effective blood pressure stabilisation was achieved with both treatments, this effect was faster and more pronounced with C/T (P < 0.0001). The incidence of tachycardia and changes in heart rate were higher with ephedrine (P < 0.01). Fewer additional boluses (P < 0.01) were required with C/T. Although favourable neonatal outcomes were reported in both groups, base deficit and lactate values were greater with ephedrine (P < 0.01). Physician satisfaction was higher with C/T. CONCLUSIONS: After C/T, tachycardia was not a problem, providing an advantage over ephedrine. Fewer additional boluses were required with C/T, suggesting greater effectiveness. An increased base deficit with ephedrine suggests reduced oxygen supply or increased demands in foetal circulation. TRIALS REGISTRATION: Clinicaltrials.gov: NCT02893241, German Clinical Trials Register: DRKS00010740.

[Contra: Is Postoperative Epidural Analgesia the Gold Standard?] / CONTRA: Postoperative Epiduralanalgesie ­ der Goldstandard?

As strategy for postoperative pain therapy, epidural analgesia (EDA) is superior to systemic opiate analgesia after abdominal and thoracic surgery. In addition, EDA may significantly reduce the incidence of complications in some large operations, such as, e.g. cardiac (myocardial infarction, atrial fibrillation) and pulmonary complications (pneumonia, atelectasis), and even reduce mortality. Intestinal motility can also be improved. However, these positive effects do not appear in all interventions and not to the same degree. Therefore, for benefit-risk assessment, it is important to know both the operation-specific benefits and disadvantages of EDA. In the meantime, the distinctly different complication rates of epidural bleeding and abscesses after EDA are also known for different surgical interventions. In large open abdominal interventions, open thorax operations, and especially open abdominal aortic surgeries, EDA reduces pain and complications. It should be noted that the positive effects of EDA have so far hardly been directly compared with those of intraoperative lidocaine administration.

The Influence of Type of Anesthesia, Perioperative Pain, and Preoperative Health Status on Chronic Pain Six Months After Thoracotomy-A Prospective Cohort Study.

BACKGROUND: Chronic post-thoracotomy pain (CPP) has a high incidence. However, less is known about risk factors and the influence of different analgesia therapies. METHODS: In this prospective cohort study, patients either received standardized epidural analgesia or began an oral analgesic protocol with controlled-release oxycodone immediately postoperatively. Patients answered a baseline questionnaire on the day before surgery and a follow-up questionnaire six months postoperatively. The questionnaire included Short-Form 12, the Neuropathic Pain Scale, and descriptive questions for CPP. Pain protocols of all patients were examined. Logistic regression was used to analyze the risk factors related to CPP. RESULTS: One hundred seventy-four patients were enrolled; data of 131 patients were available after the six-month follow-up period. Fifty-one patients (39%) had CPP six months postoperatively. Of these, more than 80% had impaired daily activity or ability to work, or reported sleeping disturbance due to CPP. The strongest predictive factors for the development of CPP were: thoracic pain for three months preoperatively (odds ratio [OR] = 3.54, 95% confidence interval [CI] = 1.69-7.40, P = 0.001), thoracic pain for 12 months preoperatively (OR = 2.73, 95% CI = 1.28-5.83, P = 0.009), and higher pain scores at rest in the first five postoperative days compared with patients without CPP (OR = 1.79, 95% CI = 1.24-2.57, P = 0.002). Neuropathic pain was present in 4.8% of patients. Patients with CPP had a reduced physical (P = 0.005) and mental health status (P = 0.03) six months after surgery compared with patients without CPP. CONCLUSIONS: Preoperative thoracic pain and higher pain scores in the first five postoperative days seem to be the strongest risk factors for the development of CPP. CPP patients reported poorer mental and physical health before and six months after surgery.

Assessing Cognitive and Psychomotor Performance in Patients with Fibromyalgia Syndrome.

INTRODUCTION: Patients with fibromyalgia syndrome (FMS) generally present with chronic widespread pain, accompanied by a range of additional and non-specific symptoms, such as fatigue, disturbed sleep, and cognitive dysfunction, which tend to increase with overall severity. Previous studies have shown moderate cognitive impairment in patients with FMS, but there are few valid data explicitly assessing the relevance of these findings to everyday functions, such as driving ability. Therefore, we studied patients with FMS to assess the impact of FMS on tests that predict driving ability. METHODS: Female patients with FMS were prospectively compared to a historical control group of healthy volunteers. The test battery comprised assessments of visual orientation, concentration, attention, vigilance, motor coordination, performance under stress, and reaction time. RESULTS: A total of 43 patients were matched to 129 controls. The results indicated that the patients' psychomotor and cognitive performances were significantly non-inferior when compared to healthy controls (with 0.05% alcohol), with the exception of motor coordination. Patients and healthy controls showed an age-related decline in test performance. Correlations were smaller in patients and reversed for vigilance which was linked to a greater FMS symptom load in younger patients. CONCLUSION: The results of the present study demonstrate that, in general, the driving ability of patients with FMS was not inferior to that of healthy volunteers based on a standardized computer-based test battery. However, variables, such as younger age, depression, anxiety, fatigue, pain, and poor motor coordination, likely contribute to the subjective perception of cognitive dysfunction in FMS.

Correlates of satisfaction with pain treatment in the acute postoperative period: results from the international PAIN OUT registry.

Patient ratings of satisfaction with their postoperative pain treatment tend to be high even in those with substantial pain. Determinants are poorly understood and have not previously been studied in large-scale, international datasets. PAIN OUT, a European Union-funded acute pain registry and research project, collects patient-reported outcome data on postoperative day 1 using the self-reported International Pain Outcome Questionnaire (IPO), and patient, clinical, and treatment characteristics. We investigated correlates of satisfaction and consistency of effects across centres and countries using multilevel regression modelling. Our sample comprised 16,868 patients (median age 55 years; 55% female) from 42 centres in 11 European countries plus Israel, USA, and Malaysia, who underwent a wide range of surgical procedures, for example, joint, limb, and digestive tract surgeries. Median satisfaction was 9 (interquartile range 7-10) on a 0-10 scale. Three IPO items showed strong associations and explained 35% of the variability present in the satisfaction variable: more pain relief received, higher allowed participation in pain treatment decisions, and no desire to have received more pain treatment. Patient factors and additional IPO items reflecting pain experience (eg, worst pain intensity), pain-related impairment, and information on pain treatment added little explanatory value, partially due to covariate correlations. Effects were highly consistent across centres and countries. We conclude that satisfaction with postoperative pain treatment is associated with the patients' actual pain experience, but more strongly with impressions of improvement and appropriateness of care. To the degree they desire, patients should be provided with information and involved in pain treatment decisions.

Procedure-specific risk factor analysis for the development of severe postoperative pain.

BACKGROUND: Many studies have analyzed risk factors for the development of severe postoperative pain with contradictory results. To date, the association of risk factors with postoperative pain intensity among different surgical procedures has not been studied and compared. METHODS: The authors selected precisely defined surgical groups (at least 150 patients each) from prospectively collected perioperative data from 105 German hospitals (2004-2010). The association of age, sex, and preoperative chronic pain intensity with worst postoperative pain intensity was studied with multiple linear and logistic regression analyses. Pooled data of the selected surgeries were studied with random-effect analysis. RESULTS: Thirty surgical procedures with a total number of 22,963 patients were compared. In each surgical procedure, preoperative chronic pain intensity and younger age were associated with higher postoperative pain intensity. A linear decline of postoperative pain with age was found. Females reported more severe pain in 21 of 23 surgeries. Analysis of pooled surgical groups indicated that postoperative pain decreased by 0.28 points (95% CI, 0.26 to 0.31) on the numeric rating scale (0 to 10) per decade age increase and postoperative pain increased by 0.14 points (95% CI, 0.13 to 0.15) for each higher score on the preoperative chronic pain scale. Females reported 0.29 points (95% CI, 0.22 to 0.37) higher pain intensity. CONCLUSIONS: Independent of the type and extent of surgery, preoperative chronic pain and younger age were associated with higher postoperative pain. Females consistently reported slightly higher pain scores regardless of the type of surgery. The clinical significance of this small sex difference has to be analyzed in future studies.

Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

UNLABELLED: PAIN OUT is a European Commission-funded project aiming at improving postoperative pain management. It combines a registry that can be useful for quality improvement and research using treatment and patient-reported outcome measures. The core of the project is a patient questionnaire-the International Pain Outcomes questionnaire-that comprises key patient-level outcomes of postoperative pain management, including pain intensity, physical and emotional functional interference, side effects, and perceptions of care. Its psychometric quality after translation and adaptation to European patients is the subject of this validation study. The questionnaire was administered to 9,727 patients in 10 languages in 8 European countries and Israel. Construct validity was assessed using factor analysis. Discriminant validity assessment used Mann-Whitney U tests to detect mean group differences between 2 surgical disciplines. Internal consistency reliability was calculated as Cronbach's alpha. Factor analysis resulted in a 3-factor structure explaining 53.6% of variance. Cronbach's alpha at overall scale level was high (.86), and for the 3 subscales was low, moderate, or high (range, .53-.89). Significant mean group differences between general and orthopedic surgery patients confirmed discriminant validity. The psychometric quality of the International Pain Outcomes questionnaire can be regarded as satisfactory. PERSPECTIVE: The International Pain Outcomes questionnaire provides an instrument for postoperative pain assessment and improvement of quality of care, which demonstrated good psychometric quality when translated into a variety of languages in a large European and Israeli patient population. This measure provides the basis for the first comprehensive postoperative pain registry in Europe and other countries.

Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures.

BACKGROUND: Severe pain after surgery remains a major problem, occurring in 20-40% of patients. Despite numerous published studies, the degree of pain following many types of surgery in everyday clinical practice is unknown. To improve postoperative pain therapy and develop procedure-specific, optimized pain-treatment protocols, types of surgery that may result in severe postoperative pain in everyday practice must first be identified. METHODS: This study considered 115,775 patients from 578 surgical wards in 105 German hospitals. A total of 70,764 patients met the inclusion criteria. On the first postoperative day, patients were asked to rate their worst pain intensity since surgery (numeric rating scale, 0-10). All surgical procedures were assigned to 529 well-defined groups. When a group contained fewer than 20 patients, the data were excluded from analysis. Finally, 50,523 patients from 179 surgical groups were compared. RESULTS: The 40 procedures with the highest pain scores (median numeric rating scale, 6-7) included 22 orthopedic/trauma procedures on the extremities. Patients reported high pain scores after many "minor" surgical procedures, including appendectomy, cholecystectomy, hemorrhoidectomy, and tonsillectomy, which ranked among the 25 procedures with highest pain intensities. A number of "major" abdominal surgeries resulted in comparatively low pain scores, often because of sufficient epidural analgesia. CONCLUSIONS: Several common minor- to medium-level surgical procedures, including some with laparoscopic approaches, resulted in unexpectedly high levels of postoperative pain. To reduce the number of patients suffering from severe pain, patients undergoing so-called minor surgery should be monitored more closely, and postsurgical pain treatment needs to comply with existing procedure-specific pain-treatment recommendations.

Effects of hydroxyethyl starch, gelatin and dextran on endothelium-derived relaxation in porcine coronary arteries.

BACKGROUND: In a pilot study we could show that hydroxyethyl starch (HES) induced a significant reduction of endothelium-dependent relaxation (EDR) and the endothelium-derived hyperpolarizing factor (EDHF). In this follow-up study we investigated whether this effect of HES was dose-dependent and whether it could be replicated with other colloids like dextran (DX) and gelatin (GL). METHODS: Rings of fresh porcine coronary arteries were consecutively tested with or without HES, DX or GL (5, 10, or 20 mg/ml). Indomethacin was added in all measurements to eliminate prostacyclin effects. Prostaglandin F2α was used for contraction and bradykinin (BK, 10⁻¹° to 10⁻5 M) for inducing EDR. After blocking nitric oxide (NO) by N-nitro-L-arginine (L-NNA), the experiments were repeated to assess the EDHF-mediated relaxation response to BK. RESULTS: HES induced a reduction in EDR for the BK concentrations of 10⁻8 and 10⁻7 M (n = 10; p < 0.05). After NO blockage with L-NNA, the relaxation response was reduced especially for the BK concentrations of 10⁻6 and 10⁻5 M (p < 0.05). GL showed a reduction in EDR with or without NO blockage with L-NNA especially for the BK concentrations of 10⁻6 and 10⁻5 M (n = 14; p < 0.05). DX induced a significant reduction in EDR for the BK concentrations of 10⁻7 and 10⁻6 M (n = 12; p < 0.05). After NO blockage with L-NNA, the relaxation response was reduced especially for the BK concentrations of 10⁻6 and 10⁻5 M (p < 0.05). CONCLUSION: For clinically relevant concentrations of HES, DX and GL a significant reduction in both NO-induced and NO-/prostacyclin-independent EDR can be found in epicardial coronary arteries of the pig.

Preoperative chronic pain in radical prostatectomy patients: preliminary evidence for enhanced susceptibility to surgically induced pain.

BACKGROUND AND OBJECTIVE: The aim of the study was to examine a possible relationship between the extent of preoperative chronic pain and the development of moderate-to-severe acute postoperative pain. METHODS: Eighty-four patients scheduled for radical prostatectomy were studied. Pain intensities after mobilization during the first 3 postoperative days were added to yield a total pain score (total pain score after mobilization, range 0-30). Pain was considered as moderate to severe at a total pain score after mobilization of 12 or higher. The preoperative severity of chronic pain disorders was measured using the Mainz Pain Staging System (I-III). Further possible preoperative risk factors for the development of intense postoperative pain that were examined included pain intensity, pain in the urological site, psychological distress (Hospital Anxiety and Depression Scale) and health-related quality of life (Short Form-12). RESULTS: Patients with moderate-to-severe preoperative chronic pain and those with higher Mainz Pain Staging System stages were significantly (P < 0.001) more likely to develop moderate-to-severe postoperative pain. Anxiety and depression scores as well as physical health (Short Form-12) were significantly associated with a total pain score after mobilization of at least 12. The development of postoperative pain was independent of the presence of preoperative pain in the urological site. CONCLUSION: This study demonstrated that higher degrees of preoperative chronic pain were associated with the development of more intense pain after radical prostatectomy. Preoperative psychological distress and reduced physical health were associated with a marked increase in postoperative pain intensity.

Chronic pain and disability after pelvic and acetabular fractures--assessment with the Mainz Pain Staging System.

BACKGROUND: Chronic posttraumatic pelvic pain (PPP) after pelvic ring fractures impacts negatively on quality of life issues. This study aimed to more clearly identify and quantify the problem. METHODS: For this cross-sectional study, patients were examined 52 (median) months after pelvic fractures. The following parameters were measured: pain chronicity (Mainz Pain Staging System [MPSS]), pain intensity (Numeric Rating Scale, 0-10), pelvic fracture outcome scores (Majeed, Pohlemann, and Bürk), pain severity (Chronic Pain Grading Questionnaire), pain-related interference with activities of daily living (Chronic Pain Grading Questionnaire), low back pain-related disability (Oswestry score), neuropathic pain (painDETECT), physical functioning (Short Form-12), and medical comorbidities (Weighted Illness Check List-20). Psychological distress was evaluated for anxiety and depression (Hospital Anxiety and Depression Scale) and mental quality of life (Short Form-12). RESULTS: Sixty-nine patients had a total of 49 pelvic and 41 acetabular fractures; 70% underwent osteosynthesis. The prevalence of PPP was 64%. Prevalence weighted with the dysfunctional pain chronicity stages MPSS II and III was 48%. Patients with pelvic fracture types (AO classification) A, B, and C had PPP prevalences of 38%, 67%, and 90%, respectively. Pain chronicity stages (MPSS) were moderately to strongly correlated with pelvic pain intensity (r = 0.57), the three pelvic fracture outcome scores (r = -0.78 to -0.90), pain-related interference (r = 0.72), Oswestry score (r = 0.68), nerve injury and neuropathic pain (r = 0.52), reduced physical (r = -0.72) and mental functioning (r = -0.58), trauma-related comorbidity (r = 0.53), anxiety (r = 0.51), and depression (r = 0.67). CONCLUSION: This study demonstrated that the intensity and prevalence of PPP are high even some 4 years after injury. The validated instruments MPSS (measuring pain chronicity) and Oswestry disability score proved to be appropriate for classifying outcome after pelvic ring fractures.

Pain prevalence and risk distribution among inpatients in a German teaching hospital.

OBJECTIVES: This study was designed to provide a cross-sectional analysis of pain prevalence, chronicity, and severity as well as the impact of pain on psychological and social variables in inpatients in various departments of a German teaching hospital. METHODS: Patients were asked to complete a questionnaire including sections on sociodemographic and socioeconomic data, pain variables, recent and past health care utilization, and screening questionnaires for depression, anxiety, and health-related quality of life. RESULTS: Of the 438 patients, 386 (88.1%) had experienced pain in the past 12 months; 367 (83.8%) reported having pain in the previous 3 months. Sixty-four percent of the pain patients stated that pain was the main reason for hospital admission; 48% reported having three or more pain sites. The most common location of pain was the back (26.9%). Pain patients showed significantly higher depression and anxiety scores and markedly reduced physical health when compared to non-pain patients. DISCUSSION: The results of this study indicate that in most medical disciplines pain is more than merely a symptom of disease. In many instances pain should be considered a serious comorbidity that can influence the outcome of medical and surgical treatment. Recent research has shown that prevention of the pain chronification process is the most promising strategy for avoiding the development of intractable pain. Acceptance, recognition, and assessment of pain as a risk factor at an early stage are essential factors. A first step might involve routine screening for pain on admission to any hospital facility, and subsequently evaluating the impact of pain on biopsychosocial functions.

Preoperative pain as a risk factor for chronic post-surgical pain - six month follow-up after radical prostatectomy.

BACKGROUND: Chronic post-surgical pain (CPSP) by definition develops for the first time after surgery and is not related to any preoperative pain. Preoperative pain is assumed to be a major risk factor for CPSP. Prospective studies to endorse this assumption are missing. METHODS: In order to assess the incidence and the risk factors for CPSP multidimensional pain and health characteristics and psychological aspects were studied in patients prior to radical prostatectomy. Follow-up questionnaires were completed three and six months after surgery. RESULTS: CPSP incidences in 84 patients after three and six months were 14.3% and 1.2%. Preoperatively, CPSP patients were assigned to higher pain chronicity stages measured with the Mainz Pain Staging System (MPSS) (p=0.003) and higher pain severity grades (Chronic Pain Grading Questionnaire) (p=0.016) than non-CPSP patients. CPSP patients reported more pain sites (p=0.001), frequent pain in urological body areas (p=0.047), previous occurrence of CPSP (p=0.008), more psychosomatic symptoms (Symptom Check List) (p=0.031), and worse mental functioning (Short Form-12) (p=0.019). Three months after surgery all CPSP patients suffered from moderate to high-risk chronic pain (MPSS stages II and III) compared to 66.7% at baseline and 82.3% had high disability pain (CPGQ grades III and IV) compared to 41.7% before surgery. CPSP patients scored significantly less favorably in physical and mental health, habitual well-being, and psychosomatic dysfunction three months after surgery. CONCLUSIONS: All patients with CPSP reported on preoperative chronic pain. Patients with preoperative pain, related or not related to the surgical site were significantly at risk to develop CPSP. High preoperative pain chronicity stages and pain severity grades were associated with CPSP. CPSP patients reported poorer mental health related quality of life and more severe psychosomatic dysfunction before and 3 months after surgery.

Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy.

AIMS: This longitudinal study was performed in order to analyze the incidence of and perioperative risk factors for the development of chronic postsurgical pain (CPSP) in patients after nephrectomy. METHODS: For baseline data acquisition, valid instruments were used for scoring sociodemographic, psychological, psychosocial, pain, pain treatment, and comorbidity factors: the Mainz Pain Staging System (MPSS) for pain chronicity, the Chronic Pain Grading Questionnaire (CPGQ), the Neuropathic Pain Scale (NPS), the Hospital Anxiety and Depression Scale (HADS), the Short Form 12 (SF-12) for health-related quality of life, the Habitual Well-Being Questionnaire (HWBQ), the Symptom Check List (SCL-8) for detecting psychosomatic dysfunction, and the Weighted Illness Check List (WICL) for evaluation of comorbidities and their impact on activities of daily living. Pain intensities were recorded over the first 6 postoperative days after nephrectomy. A sample of 35 patients was followed up for 3 and 6 months. RESULTS: Patients with more intense postoperative pain during the first 6 days had significantly higher preoperative anxiety scores. The incidence of CPSP 3 and 6 months after nephrectomy was 28.6% and 8.6%, respectively. Preoperatively increased anxiety scores, reduced physical health-related quality of life (SF-12), multiple comorbid conditions, and increased comorbidity-related disability were significantly associated with the occurrence of CPSP after 3 months. These patients also reported more severe pain during the first week after surgery. Preoperative "current pain intensity" was significantly increased in CPSP patients. CONCLUSIONS: Our results demonstrate a multifactorial development of CPSP. This process may contribute not only to the occurrence of chronic postsurgical pain but also to the biopsychosocial impairment in these patients as often seen in other chronic pain populations.

Prevalence and impact of pain in neurological inpatients of a German teaching hospital.

OBJECTIVES: The authors sought to determine the prevalence of pain among neurological inpatients and the impact of pain on psychological and social variables depending on severity and chronicity of pain. PATIENTS AND METHODS: 400 consecutive newly referred inpatients to a neurological department who were 18 years and older and able to speak German were asked to complete a self-administered epidemiological questionnaire containing demographics and socioeconomics, pain variables, health care utilization, screening for depression and anxiety, habitual well-being, and health-related quality of life. RESULTS: 320 patients (80%) complained of pain in the past 3 months. 43% showed higher pain severity -- mirroring severely disabling pain with additionally moderate to high interferences with daily activities. Two-thirds of the neurological patients suffering from pain have to be considered "chronic pain patients". Pain patients had significantly higher depression scores, bodily complaints, more severe disabilities and lower well-being scores compared to patients without pain. CONCLUSION: This study documents a high prevalence of pain with high grades of pain severity and chronicity in neurological inpatients. Pain presents a major problem as a secondary comorbid condition among neurological inpatients.

Male hormonal contraception: a double-blind, placebo-controlled study.

BACKGROUND: This study was performed to assess spermatogenesis suppression and safety of a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception. This is the first large placebo-controlled study for male hormonal contraception. DESIGN AND STUDY SUBJECTS: In this double-blind, multicenter study, we randomly assigned 354 healthy men to receive either a low- or high-release ENG implant sc combined with im TU injections (750 mg every 10 or 12 wk or 1000 mg every 12 wk) or placebo implant and injections. Treatment duration was 42 or 44 wk and posttreatment follow-up at least 24 wk. RESULTS: Overall, spermatogenesis was suppressed to 1 million/ml or less at wk 16 in 89% of men, with approximately 94% in two high-release ENG groups. Suppression was maintained up to the end of the treatment period in 91% of men. For all men who completed the treatment period, 3% never achieved 1 million/ml or less. Median recovery time to a sperm concentration above 20 million/ml was 15 wk (mean 17 wk, 95% confidence interval 16-18 wk). Treatment was well tolerated. As compared with the placebo group, more men in the active treatment groups reported adverse events such as weight gain, mood changes, acne, sweating, or libido change. For both spermatogenesis suppression and safety, differences were small between the active treatment groups. CONCLUSIONS: The combination of an ENG implant with TU injections is a well-tolerated male hormonal method, providing effective and reversible suppression of spermatogenesis. Although the results are good, there is still room for improvement, possibly by adjusting the dose regimen or changing the mode of application.

Prevalence, severity, and chronicity of pain and general health-related quality of life in patients with localized prostate cancer.

AIMS: To analyze the prevalence and the severity spectrum of pain and its relationships to health-related quality of life and the bio-psycho-social consequences of pain among patients scheduled for radical prostatectomy. METHODS: Urological inpatients completed an epidemiological pain questionnaire extensively exploring pre-operative acute and chronic pains in 21 body regions. The severity of pain was determined using von Korff's Pain Grading (CPGQ). Pain chronicity was estimated employing the Mainz Pain Staging System (MPSS). Anxiety and depressive symptoms were identified with the HADS and the Habitual Well-Being Questionnaire (FW-7). Health-related quality of life was measured using the SF-12. Comorbidities and comorbidity-related interferences with daily activities were ascertained with the Weighted Illness Checklist (WICL). RESULTS: Eighty of 115 patients (69.6%) reported about pain during the last 3 months pre-operatively. 28.7% of the pain patients had pain related to urological disease. Severe dysfunctional pain was identified by pain Grades 3 and 4 of the CPGQ in 20% and 13.8%, respectively. Advanced pain chronicity characterized by pain Stages II and III of the MPSS was present in 38.8% and 11.3%. Patients with localized prostate cancer without pain complaints had significantly better health-related quality of life and habitual well-being and lower anxiety and depression scores and fewer comorbidities. Patients with cancer-related and non-cancer pain did not differ in pain chronicity, pain severity, pain intensities, anxiety, comorbidities and physical health (SF12-PCS). CONCLUSIONS: The high prevalence of severe and chronic pain in cancer patients before scheduled radical prostatectomy--combined with considerable disability effects and markedly reduced quality of life necessitate a short routine screening-analysis of the severity spectrum of pain and psychopathology. Patient self-rated pain chronicity staging and psychological distress analysis will allow a disorder severity-guided treatment and the prevention of suffering and additional new chronic post-surgical pain.

Assessing cognitive and psychomotor performance under long-term treatment with transdermal buprenorphine in chronic noncancer pain patients.

BACKGROUND: The therapeutic use of opioids has been associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but there are no data about the effect of long-term treatment with transdermal buprenorphine on driving ability. METHODS: Thirty patients suffering from chronic noncancer pain, who had been treated with stable doses of transdermal buprenorphine, included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery, developed to assess the driving ability of traffic delinquents in Germany, was used. Attention reaction, visual orientation, motor coordination, and vigilance were evaluated. The data from 14 variables were assessed, and for each test, a relevant score was defined. As the primary end-point, the sum score of the three relevant scores was determined. A weaker statistical means to assess the patient's performance is to compare the test results to an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German law. RESULTS: According to tests that predict driving ability, patients receiving transdermal buprenorphine were shown to be noninferior to the control group. Driving ability, as defined as a result above the 16th percentile, did not differ significantly between the patients and the control group. CONCLUSION: Long-term use of transdermal buprenorphine for chronic noncancer pain does not impair driving ability, but because of the individual variability of test results, an individual assessment is recommended.