Assessing cognition and psychomotor function under long-term treatment with controlled release oxycodone in non-cancer pain patients

BACKGROUND: The therapeutic use of opioids can be associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but no data exist about the effect of long-term treatment with controlled release oxycodone (CRO) on driving ability. METHODS: Thirty patients suffering from chronic non-cancer pain who had been treated with stable doses of CRO where included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery that was developed to assess the driving ability of traffic delinquents in Germany was employed. Attention reaction, visual orientation, motor coordination and vigilance were evaluated. The data from a total of 11 parameters were assessed and for each test a relevant score was defined. As the primary endpoint the sum score of the three relevant scores was determined. A weaker statistical means to assess the patients' performance is to compare the test results with 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 legislation. RESULTS: Significant non-inferiority could not be demonstrated for the primary endpoint. However, driving ability as defined as a result above the 16th percentile did not differ significantly between the patients receiving CRO and the age-independent control group. CONCLUSION: The use of CRO does not prohibit driving, but individual assessment is necessary.     

Chronic opioid therapy in patients with chronic noncancer pain in Taiwan

Purpose

Our aim was to analyze the physiopsychosocial variables in patients with long-term opioid therapy for chronic noncancer pain (CNCP) in Taiwan.

Methods

Patients registered in the database of the National Bureau of Controlled Drugs (NBCD), Taiwan, were interviewed and completed questionnaires on pain assessment and interference in quality of life, using the Taiwanese version of the Brief Pain Inventory, and questionnaires on depressive status, using the Chinese version of the Beck Depression Inventory-II; in addition, they completed questionnaires on the adverse effects of the opioid therapy and the use of complementary and alternative medicine.

Results

Of 114 patients registered at the NBCD, Taiwan, in August 2001, 61 completed the interviewing procedures and questionnaires. The durations of pain and opioid administration were 93.6 ± 84.3 months (range, 10–480, median 72) and 54.2 ± 57.6 months (range, 6–240, median 30), respectively. Significantly reduced pain intensity (range, 8.8 ± 2.0 to 3.2 ± 2.5) and pain-induced interference with general activity (8.2 ± 2.6 to 3.5 ± 2.5), in addition to improvements in mood, walking ability, normal work, relationships with other people, sleep, and enjoyment of life, indicated remarkably improved quality of life after chronic opioid therapy. The major adverse effects of the opioids were constipation (48%), dry mouth (30%), and nausea and vomiting (21%). Almost half of the patients reported decreases in sexual desire and capability. Up to 60% of the patients received alternative medicine, including acupuncture and herbal drugs. Despite the improved quality of life, 31 of the 61 patients stated that they had moderate or severe depression.

Conclusions

The long-term use of opioids provided significant improvement of pain relief and quality of life in these patients with CNCP; this therapy is a good solution if other modalities are not effective or useful.     

吗啡病人自控镇痛滴定多瑞吉剂量控制慢性非癌性疼痛的临床研究

目的 探讨在慢性非癌性疼痛患者用吗啡病人自控镇痛(PCA)滴定芬太尼透皮贴剂(多瑞吉)剂量的可能性。方法 疼痛门诊中到重度慢性非癌性疼痛患者23例，采用开放非对照试验使用吗啡静脉PCA行多瑞吉剂量滴定治疗慢性非癌性疼痛。PCA负荷量为每隔5分钟静注吗啡1～2mg至患者视觉模拟评分(VAS)小于3分，背景量为0．5mg／h，冲击量为1～2mg，锁定时间10min，总量无限定。记录24h静脉吗啡用量，换算成多瑞吉贴剂。使用多瑞吉后，保留PCA的冲击量12h再停药。观察并记录吗啡静脉PCA前、PCA中、PCA-Bolus 多瑞吉(12h)和多瑞吉24～72h患者的疼痛强度和不良反应。结果本文所有患者均在10～30min获得良好镇痛(VAS小于3分)并能充分有效维持72h。观察期间常见不良反应为呕心、呕吐和头晕，转换为多瑞吉后不良反应逐渐下降减少。结论 采用吗啡静脉PCA滴定，可以快速有效镇痛，使多瑞吉应用剂量迅速个体化。     

A long-term open, clinical and pharmacokinetic assessment of sublingual buprenorphine in patients suffering from chronic pain

Buprenorphine was administered as sublingual tablets to 70 patients suffering from chronic pain of malignant or non-malignant origin. Daily doses ranging from 0.4 mg to 3.2 mg were administered and good analgesia was reported by the majority of patients. The most common unwanted effects were drowsiness/sleepiness, nausea and/or vomiting and sweating which appeared to be dose related but the incidence of dizziness was not related to daily dose. The incidence of all these unwanted effects except drowsiness/sleepiness decreased after the first week's treatment. No buprenorphine related changes in vital signs or laboratory values were observed and no signs of tolerance or physical dependence were seen in the short term period after discontinuation of treatment. A significant positive correlation between buprenorphine plasma concentration and daily dose was observed but there was no correlation between plasma levels and pain relief.     

芬太尼透皮贴剂治疗慢性非癌性疼痛的可行性

目的 观察芬太尼透皮贴剂(多瑞吉)对中度到重度慢性非癌性痛的镇痛效果及不良反应。方法 选取本院疼痛门诊中度到重度慢性非癌痛患者46例,采用开放非对照试验设计使用多瑞吉,剂量从25μg/g,h开始,疗程15 d。观察患者的疼痛程度、生活质量、不良反应及停药反应。结果46例患者中有38例完成试验,8例因不良反应退出。多瑞吉治疗后患者的疼痛程度明显降低(P<0.01),治疗有效率达94.74％;患者的生活质量显著改善(P<0.01)。其不良反应主要有恶心、头晕、呕吐、多汗、嗜睡、厌食等,但大部分可在发生后1周内自行消失。停药后均未出现戒断症状。结论多瑞吉治疗中度以上慢性非癌性疼痛,镇痛效果好、使用方便、安全,在严格选择患者和严密监控的条件下可用于临床。     

Spinal cord stimulation--a long-term evaluation in patients with chronic pain

Spinal cord stimulation (SCS) is an established treatment modality for chronic pain, angina pectoris, and peripheral vascular disease. This study evaluates experience with SCS over a 13-year period with emphasis on surgical complications, revisions and pain relief. It took the form of a retrospective study of medical/surgical records coupled with a postal/telephone questionnaire. The subjects consisted of seventy patients, aged from 21 to 76 years (mean 47; median 46), with severe, chronic pain refractory to conventional treatment, who underwent SCS implantation between 1984 and 1997. It investigated surgical revisions, complications and pain relief. There were 72 surgical revisions comprising electrode replacement/repositioning (32), generator replacement (22), cable failure (6) and implant removal (12). Half the devices were revised within 3 years (95% confidence interval: 2-5 years) of implantation. Six (8.6%) implants became infected. Sixty per cent of patients reported substantial relief of pain. This study shows that the majority of patients undergoing SCS derive significant benefit in terms of pain relief, but commonly require surgical revisions due to both technical and biological factors. These devices require systematic evaluation to determine optimal usage, clinical effectiveness and cost-benefit analysis.     

认知行为训练对慢性腰痛患者疼痛自我效能的影响

目的 探讨认知行为训练对慢性腰痛(chronic back pain,CBP)患者疼痛自我效能的影响.方法 选择2018年2月～2019年12月在本院就诊的94例CBP患者作为研究对象,采用随机数字表法分为对照组和观察组各47例.对照组给予推拿按摩治疗,观察组在对照组的基础上给予认知行为训练.观察两组患者干预前后疼痛强...     

长期接受慢性疼痛治疗患者的围术期疼痛管理进展

背景 慢性疼痛患者往往长期接受一系列的治疗措施来控制疼痛,如因某种疾病要接受手术治疗时,这类患者的围术期疼痛管理是非常棘手的. 目的 了解不同慢性疼痛治疗措施下患者的围术期疼痛管理进展. 内容 分别阐述口服阿片药物、抗抑郁药、抗惊厥药,应用脊髓刺激器及鞘内药物输注系统等慢性疼痛治疗措施下患者的围术期疼痛管理策略.趋向 对长期接受慢性疼痛治疗患者的围术期疼痛管理的研究,将有助于提高这类患者在围术期的舒适度及安全度,加快术后康复.     

Comparison of buprenorphine with morphine in the treatment of postoperative pain in children

The safety and efficacy of buprenorphine and morphine as postoperative analgesics for children were compared in 60 boys and girls 4 to 14 years old having elective orthopedic operations on upper or lower extremities. The drugs were given in a double-blind manner initially intravenously and thereafter by sublingual buprenorphine or intramuscular morphine administered as required to relieve pain until the third postoperative morning. The IV dose needed to achieve complete initial analgesia was 5.2 +/- 2.8 micrograms/kg buprenorphine and 166 +/- 100 micrograms/kg morphine. The duration of effect was significantly longer with buprenorphine than with morphine, 248 +/- 314 and 114 +/- 109 minutes, respectively (P = 0.03). The most common side effects were nausea and vomiting (28 and 16%) and urinary retention (21 and 19%) in the buprenorphine and morphine groups, respectively. Analgesia with sublingual buprenorphine was as effective and reliable as with intramuscular morphine but a longer duration of action could not be demonstrated.     

Perineural morphine in patients with chronic ischemic lower extremity pain: efficacy and long-term results

Purpose  To compare the efficacy, safety, and impact on daily activity of peripherally administered morphine plus a local anesthetic with that of a local anesthetic alone in patients with chronic ischemic lower extremity pain. Methods  Fifty patients with lower extremity ischemic pain due to peripheral vascular disease who had undergone surgical sympathectomy and who were not responding to systemic analgesics were included. Study treatments were bupivacaine plus morphine or bupivacaine alone administered via popliteal catheter. Each patient received both study treatments consecutively, with a washout period, in a double-blind fashion. The effects of treatments on pain severity (numerical rating scale), duration of analgesia, and daily activity were evaluated. Then, patients were asked to state which one of the treatments they preferred for the long term, during which catheter outcomes were evaluated. Results  Both treatments provided significant pain control compared to baseline at all time points, both at rest and during activity. However, the combination treatment provided superior pain control at 8 and 12 h, and longer analgesia duration (12 ± 2 h vs 9 ± 1 h; P < 0.001). During the long term, treatments were similar in terms of analgesia. The combination treatment had a higher incidence of side effects (30% vs 0%; P < 0.001). Conclusion  A peripherally administered bupivacaine plus morphine combination provided better and longer analgesia for ischemic pain compared to bupivacaine alone for the short term, but not for the long term. On the other hand, our results show that continuous popliteal treatment is an effective, safe, and comfortable modality for long-term use in the home setting for patients with intractable chronic pain.     

Transdermal buprenorphine combined with spinal morphine and naropine for pain relief in chronic peripheral vasculopathy

The AIM: of this study was to evaluate the effectiveness and the safety of the association of buprenorphine transdermal delivery system (TDS) (Transtec TDS) and peridural infusion of morphine and naropine, for the control of ischemic pain in patients suffering from peripheral arteriopathy. The administration of an opioid, pure agonist, as morphine, with a partial agonist opioid, as the buprenorphine, was used. Buprenorphine has shown a higher liposolubility in supraspinal districts, while the morphine acts above all on the mu receptor subtype of the spinal cord. In this way it's possible a contemporary activation of spinal and supraspinal antinociceptive mechanisms. Furthermore, the incidence of side effects is reduced by buprenorphine, which antagonizes the central effect of morphine. In this study, 43 patients were recruited, suffering from chronic pain in Fontaine stage III-IV obstructive arteriopathy, scheduled for surgery. The patients have been divided into 2 equal groups for age, sex, pathology and intensity of pain. In the first group (TTDS), at first session, a buprenorphine patch 35 microg/h (Transtec TDS) has been applied, and after 24h, a peridural catheter with elastomeric system was positioned; 100 mL (2 mg/mL) of naropine and 2 mg of morphine, 4 mL/h in 24 h, were administered. In the second group (naropine morphine, NM), buprenorphine patch was not applied and analgesia was obtained only by using peridural catheter with elastomeric system at the same doses administered in the first group. At the daily control patients with visual analogical scale (VAS)=or>40 mm received an additional dose of morphine from 2 mg to 6+/-2 mg. VAS (0-100 mm) and the evaluation of the number of the hours of sleep were used to evaluate the analgesic effectiveness of the treatment. Side effects, opioid tolerance and abuse were always recorded. All parameters were evaluated daily for a period of 20+/-5 days. The results indicate that in group TTDS there was an improvement of pain symptomatology, also confirmed by the increased hours of sleep and the lower incidence of side effects. Instead in group NM, pain control was less effective, 18 patients needed a rescue dose of morphine, and the incidence of side effects increased.     

Assessing the benefits and harms of statin treatment in patients with chronic kidney disease

This Practice Point commentary discusses a meta-analysis by Strippoli et al. that included 50 randomized and quasi-randomized trials of statins in patients with different stages of kidney disease (predialysis, dialysis and transplantation; n = 30,144). The authors found that statins safely reduced lipid concentrations and the risk of cardiovascular events and cardiovascular mortality, but that the agents had no effect on all-cause mortality overall and had uncertain renoprotective effects. The analysis was comprehensive and well executed. A decreased risk of all-cause mortality with statins was found in studies of predialysis patients but not in studies of renal transplant recipients or patients on chronic dialysis. Statin doses used in the trials were well tolerated and safe in all subgroups of patients with chronic kidney disease; therefore, we feel that statin use to maintain LDL cholesterol below 100 mg/dl (2.6 mmol/l) should be initiated to potentially decrease cardiovascular risk in such patients. The benefits of statin therapy on all-cause mortality and the clinically significant benefits of this treatment on progression of kidney disease are still unclear, and additional trial evidence in patients with chronic kidney disease is needed.     

Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management

Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen’s d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes.     

A short, intensive cognitive behavioral pain management program reduces health-care use in patients with chronic low back pain

Purpose

Cognitive behavioral interventions are recommended as non-invasive treatment options for patients with chronic low back pain (CLBP). However, most treatment effects are small and short-lived. Although a 2-week intensive pain management program for patients with CLBP seems to be effective, the long-term results are not known. The purpose of this study is to evaluate the stability of the 2-year follow-up results and whether this is reflected in the use of health-care services.

Methods

A prospective cohort study was performed. Pre-treatment characteristics of patients and data of outcomes obtained at 1-year follow-up were used. At 2-year follow-up a structured interview was conducted following the principles of a post-marketing survey. Outcomes included daily functioning, quality of life, current intensity of pain, disturbance of pain during daily activities, and indicators of the use of pain medication and health-care services.

Results

Of the 90 eligible patients 85 (94%) participated in the post-marketing survey. The 1-year clinical relevant effects are maintained at 2-year follow-up. Effect sizes for functioning and quality of life were large. More than 65% reached preset minimal clinically important differences. At pre-treatment all patients consulted their general practitioner (GP) and medical specialist (MS). At 2-year follow-up 73% reported having consulted neither a GP nor an MS during the previous year. Most of the patients indicated not to use any pain medication (57%) and the percentage patients using opioids have decreased (14%). Moreover, 81% reported to be at work.

Conclusions

The gained results from selected and motivated patients with longstanding CLBP at 1-year follow-up are stable at 2-year follow-up. Above all, most of the participants are at work and results indicate that the use of both pain medication and health care have decreased substantially.