病人自控硬膜外镇痛与静脉镇痛用于全髋置换术的比较

目的比较老年病人全髋置换术术后自控硬膜外镇痛（PCEA）与自控静脉镇痛（PCIA）的效果和不良反应。方法选择48例美国麻醉学会分级（ASA）I-Ⅲ级,择期硬膜外麻醉下行全髋置换术的老年病人,术后分别行PCEA（E组）和PCIA（I组）。PCEA药物用1.25mg／ml的罗哌卡因,镇痛泵参数设置为基础量3ml／h、自控给药量（PCA量）5ml、锁定时间30min。PCIA药物用10μg／ml的芬太尼,泵参数为基础量2ml／h、PCA量3ml、锁定时间15min。观察术后48h的镇痛效果和不良反应情况。结果两组术后视觉模拟评分法（VAS）均低于3,术毕初始12h内PCEA提供更低的VAS（P〈0.05）,24-48h两组VAS差异无显著性。术后PCEA病人的低血压、下肢麻木及硬膜外导管脱落的发生率显著高于I组（P〈0.05）。恶心、呕吐、谵妄、皮肤瘙瘁等发生率两组相似。结论老年病人全髋置换术术后病人自控硬膜外镇痛的效果优于自控静脉镇痛,但镇痛管理较为困难。     

Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study

A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks’ washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.     

Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized,blinded, placebo-controlled trial

This study evaluated the efficacy of transcutaneous electrical nerve stimulation (TENS) in reducing pain and hyperalgesia and increasing function after total knee arthroplasty (TKA). We hypothesized that participants using TENS during rehabilitation exercises would report significantly lower pain during range-of-motion (ROM) activity and fast walking but not at rest, would have less hyperalgesia, and would have better function than participants receiving placebo-TENS or standard care. We also hypothesized that change in ROM pain would differ based on psychological characteristics (trait anxiety, pain catastrophizing, and depression) and treatment group. This prospective, randomized study used intent-to-treat analyses in 317 participants after primary, unilateral TKA. Assessors, blinded to treatment allocation, measured pain, function (ROM and gait speed), and hyperalgesia (quantitative sensory tests) postoperatively and 6 weeks after surgery. Analgesic intake, anxiety, depression, and pain catastrophizing were also assessed. TENS participants used it 1 to 2 times per day at 42 mA (on average) and had less pain postoperatively during active knee extension (P = .019) and fast walking (P = .006) than standard care participants. TENS and placebo-TENS were not significantly different. TENS participants who scored low on anxiety and pain catastrophizing had a greater reduction in ROM pain at 6 weeks than those who scored high on these factors (P = .002 and P = .03). Both TENS and placebo-TENS participants had less postoperative mechanical hyperalgesia (P = .03–.01) than standard care participants. Supplementing pharmacologic analgesia with TENS during rehabilitation exercises reduces movement pain postoperatively, but a placebo influence exists and the effect is gone by 6 weeks. Patients with low anxiety and pain catastrophizing may benefit most from TENS.     

Effect of vitamin D on musculoskeletal pain and headache: A randomized,double-blind,placebo-controlled trial among adult ethnic minorities in Norway

Immigrants from South Asia, the Middle East, and Africa living in Northern Europe frequently have low vitamin D levels and more pain compared to the native Western population. The aim of this study was to examine whether daily vitamin D₃ (25 μg/d or 10 μg/d) supplementation for 16 weeks would improve musculoskeletal pain or headache compared to placebo. This randomized, double-blind, placebo-controlled, parallel-group trial recruited 251 participants aged 18 to 50 years, and 215 (86%) attended the follow-up visit. The pain measures were occurrence, anatomical localization, and degree of musculoskeletal pain, as measured by visual analogue scale (VAS) score during the past 2 weeks. Headache was measured with VAS and the Headache Impact Test (HIT-6) questionnaire. At baseline, females reported more pain sites (4.7) than males (3.4), and only 7% reported no pain in the past 2 weeks. During the past 4 weeks, 63% reported headache with a high mean HIT-6 score of 60 (SD 7). At follow-up, vitamin D level, measured as serum 25(OH)D₃, increased from 27 nmol/L to 52 nmol/L and from 27 nmol/L to 43 nmol/L in the 25-μg and 10-μg supplementation groups, respectively, whereas serum 25(OH)D₃ did not change in the placebo group. Pain scores and headache scores were improved at follow-up compared with baseline. The use of vitamin D supplements, however, showed no significant effect on the occurrence, anatomical localization, and degree of pain or headache compared to placebo.     

Ultrasound-guided,direct suprainguinal injection for fascia iliaca block for total hip arthroplasty: A retrospective study

BACKGROUNDPeripheral regional block combined with general anesthesia might be a preferable anesthetic regimen for elderly patients undergoing total hip arthroplasty.AIMTo investigate whether ultrasound-guided, direct suprainguinal injection for fascia iliaca block accelerated recovery after general anesthesia and relieved postoperative pain after total hip arthroplasty.METHODSPatients who underwent total hip arthroplasty under general anesthesia in 2015 or 2019 at The Second Affiliated Hospital of Xuzhou Medical University were retrospectively analyzed. The patients were grouped based on whether preoperative suprainguinal fascia iliaca block was performed or not. The time to tracheal extubation and time spent in the post-anesthesia care unit (PACU), intraoperative remifentanil dosage, fentanyl consumption in the PACU, postoperative cumulative fentanyl consumption within 48 h after operation, visual analogue scale at rest and during movement on the first and second days after surgery, and adverse reactions were compared.RESULTSThirty-one elderly patients who underwent total hip arthroplasty were included in the study (block group, n = 16; no-block group, n = 15). The visual analog scale scores at rest and during movement on the first and second days were significantly lower in the block group than in the no-block group (all P < 0.05). Compared with the no-block group, the intraoperative remifentanil dosage was lower, the time to tracheal extubation and the time spent in the PACU were shorter in the block group (all P < 0.01). Fentanyl consumption in the PACU and postoperative cumulative fentanyl consumption in 48 h after operation were lower in the block group (all P < 0.01). The incidence of dizziness was higher in the no-block group than in the block group (P = 0.037).CONCLUSIONUltrasound-guided, direct suprainguinal injection for fascia iliaca block led to faster recovery after general anesthesia and early postoperative pain relief in elderly patients undergoing total hip arthroplasty.     

The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial

ObjectiveTo evaluate the efficacy of Mindfulness-Based Stress Reduction (MBSR) in improving pain and physical function following total joint arthroplasty (TJA).DesignTwo-group, parallel-group, randomised controlled trial, conducted between September 2012 and May 2017.SettingSingle centre study conducted at a University-affiliated, tertiary hospital.InterventionPeople with arthritis scheduled for TJA, with a well-being score <40 (Short Form-12 Survey) were randomly allocated to a pre-surgery eight-week MBSR program or treatment as usual (TAU).Outcome MeasuresSelf-reported joint pain and function at 12 months post-surgery, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes were knee stiffness and global improvement (WOMAC); physical and psychological well-being (Veterans RAND 12-item Health Survey); self-efficacy (Arthritis Self-Efficacy Scale); and mindfulness (5-Factor Mindfulness Questionnaire).Results127 participants were randomised; 65 to MBSR and 62 to TAU, of which 45 participants allocated to the intervention and 56 participants allocated to usual care proceeded to surgery and 100 (99%) completed primary outcome measures. Greater improvements in knee pain (mean difference, -10.3 points, 95% CI -19.0 to -1.6; P = 0.021) and function (mean difference, -10.2 points, 95% CI -19.2 to -1.3; P = 0.025) at 12 months post-surgery were observed in the MBSR group compared to the TAU group. A between group difference in global scores (-9.5 points, 95% CI -17.9 to -1.1; P = 0.027) was also observed. No other differences in secondary outcomes were observed.ConclusionMBSR improves post-surgery pain and function in people with psychological distress undergoing TJA. Further research is required to examine potential barriers to broader implementation and uptake.     

Screw penetration of the iliopsoas muscle causing late-onset pain after total hip arthroplasty: A case report

BACKGROUNDPostoperative pain following total hip arthroplasty (THA) may occur in a few patients but may pose a significant challenge to surgeons if the etiology is not identified. Herein, we report the case of a patient who developed late-onset pain following THA due to screw penetration of the iliopsoas tendon.CASE SUMMARYWe report the case of a 77-year-old man who developed inguinal pain 7 years after THA. While the symptoms resembled that of iliopsoas impingement by the acetabular cup, the pain resolved only when the supplementary acetabular screw protruding through the ilium was decompressed. Decompression was performed using the pararectus approach. The patient was able to ambulate pain-free immediately after surgery.CONCLUSIONA protruded screw through the ilium may penetrate the iliopsoas muscle, causing pain following THA. Pain may resolve with the decompression of the protruded screw.     

A randomized,placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster

Although acute pain in patients with herpes zoster can be severe and has a substantial impact on health-related quality of life, there have been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects ?50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24 h ? 3 on a 0–10 rating scale initiated 7 days of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo. Subjects were evaluated for adverse effects of treatment, acute pain, and health-related quality of life. The results showed that CR-oxycodone and gabapentin were generally safe and were associated with adverse events that reflect well-known effects of these medications. Discontinuing participation in the trial, primarily associated with constipation, occurred more frequently in subjects randomized to CR-oxycodone (27.6%) compared with placebo (6.9%). Treatment with CR-oxycodone reduced the mean worst pain over days 1–8 (p = 0.01) and days 1–14 (p = 0.02) relative to placebo but not throughout the entire 28-day treatment period as pain resolved in most subjects. Gabapentin did not provide significantly greater pain relief than placebo, although the data for the first week were consistent with a modest benefit. By demonstrating that CR-oxycodone is safe, generally adequately tolerated, and appears to have efficacy for relieving acute pain, the results of this clinical trial provide a foundation for evidence-based treatment for acute pain in herpes zoster.     

A randomized,double-blind,placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy

The objective of these studies was to assess the efficacy and safety of pregabalin in the treatment of human immunodeficiency virus (HIV)–associated neuropathic pain. Patients with HIV-associated distal sensory polyneuropathy (DSP) were randomized to treatment with flexible-dose pregabalin (150–600 mg/day) or placebo for 17 weeks in a single-blind, placebo lead-in, randomized, double-blind, parallel-group, placebo-controlled multinational trial. The primary efficacy outcome was the change in mean pain score on an 11-point numeric rating scale (NRS) from baseline to study endpoint. Participants who completed this trial were invited to participate in a 6-month open-label extension study with pregabalin. Of the 377 patients enrolled in the randomized controlled trial (pregabalin, n = 183; placebo, n = 194), 68.4% completed treatment. In the open-label extension, 217 patients were treated and 59.4% completed treatment. Both studies were terminated by the sponsor after a preplanned interim analysis indicated trial futility. At endpoint, the change from baseline in least-squares mean NRS pain scores in the intent-to-treat population was −2.04 for pregabalin versus −2.11 for placebo (P = .709). There were no significant differences between the pregabalin and placebo groups in the secondary efficacy measures. Incidence of adverse events was lower than seen in previous pregabalin studies. Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. Studies such as these, which fail to support their primary hypotheses, may be important in informing the methodology of future trials, especially when novel approaches to limit variability in the control group are included.     

Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: a randomized, controlled, double-blind multicenter study

Evidence of an effect by botulinum toxins is still lacking for most pain conditions. In the present randomized, placebo-controlled, crossover multicenter study, the efficacy of botulinum toxin type A (BTX-A) was investigated in patients with persistent myofascial temporomandibular disorders (TMD). Twenty-one patients with myofascial TMD without adequate pain relief after conventional treatment participated. A total of 50 U of BTX-A or isotonic saline (control) was randomly injected into 3 standardized sites of the painful masseter muscles. Follow-up was performed after 1 and 3 months, followed by a 1-month washout period, after which crossover occurred. Pain intensity at rest was the primary outcome measure, while physical and emotional function, global improvement, side effects, and clinical measures were additional outcome measures. There was no main difference between drugs (ANOVA; P = .163), but there was a significant time effect (P < .001), so BTX-A reduced mean (SD) percent change of pain intensity by 30 (33%) after 1 month and by 23 (30%) after 3 months compared to 11 (40%) and 4 (33%) for saline. The number of patients who received a 30% pain reduction was not significantly larger for BTX-A than after saline at any follow-up visit. The number needed to treat was 11 after 1 month and 7 after 3 months. There were no significant changes after treatment in any other outcome measures, with the exception of pain on palpation, which decreased 3 months after saline injection (P < .05). These results do not indicate a clinical relevant effect of BTX-A in patients with persistent myofascial TMD pain.     

Daily repetitive transcranial magnetic stimulation of primary motor cortex for neuropathic pain: A randomized,multicenter, double-blind,crossover, sham-controlled trial

There is little evidence for multisession repetitive transcranial magnetic stimulation (rTMS) on pain relief in patients with neuropathic pain (NP), although single-session rTMS was suggested to provide transient pain relief in NP patients. We aimed to assess the efficacy and safety of 10 daily rTMS in NP patients. We conducted a randomized, double-blind, sham-controlled, crossover study at 7 centers. Seventy NP patients were randomly assigned to 2 groups. A series of 10 daily 5-Hz rTMS (500 pulses/session) of primary motor cortex (M1) or sham stimulation was applied to each patient with a follow-up of 17 days. The primary outcome was short-term pain relief assessed using a visual analogue scale (VAS). The secondary outcomes were short-term change in the short form of the McGill pain questionnaire (SF-MPQ), cumulative changes in the following scores (VAS, SF-MPQ, the Patient Global Impression of Change scale [PGIC], and the Beck Depression Inventory [BDI]), and the incidence of adverse events. Analysis was by intention to treat. This trial is registered with the University hospital Medical Information Network Clinical Trials Registry. Sixty-four NP patients were included in the intention-to-treat analysis. The real rTMS, compared with the sham, showed significant short-term improvements in VAS and SF-MPQ scores without a carry-over effect. PGIC scores were significantly better in real rTMS compared with sham during the period with daily rTMS. There were no significant cumulative improvements in VAS, SF-MPQ, and BDI. No serious adverse events were observed. Our findings demonstrate that daily high-frequency rTMS of M1 is tolerable and transiently provides modest pain relief in NP patients.     

Efficacy and safety of morphine-6-glucuronide (M6G) for postoperative pain relief: A randomized,double-blind study

AimsThe aim of the study was to assess analgesia and safety effects of a range of intravenous doses of M6G (10, 20 and 30 mg/70 kg), compared to placebo, in postoperative patients.MethodsIn a randomized, multicentre, double-blind study, patients undergoing knee replacement surgery under spinal anaesthesia were administered one of three doses of M6G, or placebo, 150 min after spinal nerve block. Morphine rescue medication was available via a PCA pump. The key index of analgesic activity was determined as the amount of morphine consumed by the patient over 12 and 24 h after M6G administration. Time to first use of rescue medication, VAS and global pain assessment scales were also recorded. Safety was assessed by monitoring supine blood pressure, heart rate, respiratory rate and body temperature and typical opioid side-effects of PONV and sedation.ResultsA total of 170 patients were dosed with study medication. M6G induced a dose-related reduction in morphine use over 24-h that reached statistical significance compared to placebo at M6G 30 mg/70 kg. There was no clear relationship between M6G dose and time to first use of PCA morphine. Pain relief was similar in all groups. M6G showed small, but inconsistent effects on the cardiovascular system and on sedation and no effects were observed on respiration or PONV.ConclusionM6G induced long-lasting dose-related analgesic effects in postoperative patients with limited effects on cardiorespiratory systems or of opioid-like side-effects. M6G is an effective opioid for the treatment of moderate to severe postoperative pain.     

Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain

Our objective was to investigate the efficacy and safety of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, in subjects with non-cancer pain and opioid-induced bowel dysfunction (OBD), and to identify at least one treatment regimen that improves OBD. Following a 2-week baseline period, 522 subjects reporting <3 spontaneous bowel movements (SBMs)/week (with >or=25% accompanied by a sensation of incomplete evacuation, straining, or lumpy hard stools), requiring analgesia equivalent to >or=30 mg oral morphine/day were randomized to alvimopan 0.5mg twice daily (BID), 1mg once daily (QD), 1mg BID, or placebo for 6 weeks. Compared with placebo, there was a statistically and clinically significant increase in mean weekly SBM frequency over the initial 3 weeks of treatment (primary endpoint) with alvimopan 0.5mg BID (+1.71 mean SBMs/week), alvimopan 1mg QD (+1.64) and alvimopan 1mg BID (+2.52); P<0.001 for all comparisons. Increased SBM frequency and additional treatment effects, including improvements in symptoms such as straining, stool consistency, incomplete evacuation, abdominal bloating/discomfort, and decreased appetite, were sustained over 6 weeks. The most frequently reported adverse events were abdominal pain, nausea, and diarrhea, occurring more frequently in the higher dosage groups. The alvimopan 0.5mg BID regimen demonstrated the best benefit-to-risk profile for managing OBD with alvimopan in this study population, with a side effect profile similar to that of placebo. There was no evidence of opioid analgesia antagonism. Competitive peripheral antagonism of opioids with alvimopan can restore GI function and relieve OBD without compromising analgesia.     

The efficacy of Tung’s acupuncture for sex hormones in polycystic ovary syndrome: A randomized controlled trial

BackgroundPolycystic ovary syndrome (PCOS) is a common and heterogeneous endocrine disorder in reproductive-age women. Tung's acupuncture, a Traditional Chinese Medicine (TCM) treatment, is widely used for PCOS in East Asia, but evidence on its efficacy is rare. The aim of this RCT study was to examine whether the Tung’s acupuncture could be a complementary treatment method for PCOS.MethodsA total of 60 PCOS patients were randomly assigned to a Tung's acupuncture group (n = 30) or a cyproterone acetate/ethinylestradiol (CPA/EE) group (n = 30). Each participant received treatments for 12 weeks to assess the short-term treatment efficacy and then followed up for another 12 weeks to assess the long-term treatment efficacy. The primary outcome examined was change in the ratio of luteinizing hormone (LH) to follicle-stimulating hormone (FSH); the secondary outcomes examined were changes in body mass index (BMI), LH, FSH, total testosterone (TT), ovarian volume, polycystic ovary number and menstrual frequency.ResultsBoth groups showed significant reductions in the LH/FSH ratio, LH and TT after 12-week treatment (p < 0.001) and 12-week follow-up (p < 0.05). No significant differences existed between the two groups (p > 0.05). Both groups showed significant improvement in BMI, menstrual frequency and polycystic ovary number after 12-week treatment (p < 0.05).ConclusionCompared with CPA/EE, Tung’s acupuncture showed no better improvement on LH/FSH ratio for PCOS although it could reduce the ratio. Tung's acupuncture might have some effect on long-term weight control and menstruation frequency. Further studies addressing this study’s limitations are recommended.     

Effects of motion style acupuncture treatment in acute low back pain patients with severe disability: A multicenter,randomized, controlled,comparative effectiveness trial

Reviews of the efficacy of acupuncture as a treatment for acute low back pain (aLBP) have shown that there is insufficient evidence for its effect and that more research is needed. Motion style acupuncture treatment (MSAT) is novel in that it requires a part of the patient’s body to move passively or actively while acupuncture needles are retained. A multicenter, randomized, comparative effectiveness trial was conducted to evaluate the effects of MSAT in aLBP with severe disability. A total of 58 aLBP patients with severe functional disability (defined per Oswestry Disability Index [ODI] ?60%) were recruited and assigned randomly to receive 1 session of either conventional diclofenac injection (n = 29) or MSAT (n = 29). The primary outcome measured improvement in LBP using the 10-point numerical rating scale of LBP, and the secondary outcome assessed disability using the Oswestry Disability Index at 30 minutes and at 2, 4, and 24 weeks after treatment. Analyses were by intention to treat. The numerical rating scale of the MSAT group decreased 3.12 (95% confidence interval = 2.26, 3.98; P < .0001) more than that of the injection group and the Oswestry Disability Index of the MSAT group decreased 32.95% (95% confidence interval = 26.88, 39.03; P < .0001) more than that of the injection group, respectively. The difference between the 2 groups maintained statistical significance at 2 and 4 weeks after treatment. These results suggest that MSAT has positive effects on immediate pain relief and the functional recovery of aLBP patients with severe disability.     

The efficacy of a glial inhibitor,minocycline, for preventing persistent pain after lumbar discectomy: A randomized,double-blind,controlled study

Minocycline strongly inhibits microglial activation, which contributes to central sensitization, a major mechanism underlying chronic pain development. We hypothesized that the perioperative administration of minocycline might decrease persistent pain after lumbar discectomy. We randomly assigned 100 patients undergoing scheduled lumbar discectomy to placebo and minocycline groups. The minocycline group received 100 mg minocycline orally, twice daily, beginning the evening before surgery and continuing for 8 days. The primary outcome was the change in lower limb pain intensity at rest between baseline and 3 months. Secondary outcomes were pain intensity on movement, the incidence of persistent pain and chronic neuropathic pain, back pain intensity at rest and on movement, and changes in Neuropathic Pain Symptom Inventory, Brief Pain Inventory, and Roland-Morris scores at 3 months. An intention-to-treat analysis was performed for patients assessed from the day before surgery to 3 months. The decrease in lower limb pain intensity was similar in the placebo and minocycline groups, both at rest −1.7 ± 1.6 vs −2.3 ± 2.4 and on movement −2.5 ± 2.1 vs −3.4 ± 2.9. The incidence and intensity of neuropathic pain and functional scores did not differ between the minocycline and placebo groups. Exploratory analysis suggested that minocycline might be effective in a subgroup of patients with predominantly deep spontaneous pain at baseline. Perioperative minocycline administration for 8 days does not improve persistent pain after lumbar discectomy.