Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS.The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management (‘SQS arm’) versus optimized medical management alone (‘OMM arm’) in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline.The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014.NCT01711619ClinicalTrials.gov  Chronic back and leg pain (CBLP) is a diffusely defined group of pain conditions, ranging from chronic low back  pain to persisting hip, buttock and leg (‘radicular’) pain and often consists of a combination of both . It is eGreater success has been reported in the treatment of patients with CBLP and FBSS that present with radicular (or leg) pain rather than with axial (or low back) pain ,6. RandoPeripheral neuromodulation includes two distinct technical approaches: the lead can be placed percutaneously or via an open surgical technique. Peripheral nerve stimulation (PNS) utilizing an open surgical technique was first reported in 1967 . SubcutaThe remainder of this paper focuses on SQS.To the best of our knowledge, no previous systematic review of SQS for CBLP or FBSS has been published. We, therefore, undertook a comprehensive search of a number of electronic databases including MEDLINE, EMBASE and the Cochrane Library. Our search included a combination of Medical Subject Headings that included: ‘failed back surgery syndrome’, OR ‘back pain’ OR ‘chronic leg pain’ OR ‘post laminectomy’ AND ‘peripheral nerve stimulation’ OR ‘electric stimulation’ OR ‘subcutaneous stimulation’. Issues of ‘Neuromodulation’ were hand searched and the reference list checked from the Medtronic dossier of evidence of peripheral nerve stimulation that was submitted to the TuV in 2011 for purposes of obtaining Conformité Européenne (CE) Mark for percutaneous PNS [unpublished results].The study selection process is shown in Additional file All included studies employed a case series design  and included a total of 191 patients with CBLP implanted with SQS, of which a proportion of patients experienced CBLP following lumbar surgery, that is, FBSS. Although the precise location of pain was often not clearly stated, studies appear to recruit patients specifically with a back component of pain. Only one study explicitly stated that they included individuals with both back and leg pain . StudiesThe quality of included studies was assessed on the basis of the following five criteria: 1) prospective design, (2) consecutive or random sampling, (3) explicit statement of inclusion/exclusion criteria, (4) independent outcome assessment and (5) clear statement of loss to follow-up/withdrawals . Details prospectStudies consistently reported that patients experienced pain relief following SQS implantation  patients experienced 1 or more device-related complication ,18,19. R% patientIn summary, our systematic review identified a growing body of international prospective and retrospective case series data showing that CBLP and FBSS patients experience pain relief following SQS, a reduction in their analgesic therapy and an improvement in functional well-being over the short to medium term. The reduction in pain observed across studies compares favorably with the clinically important change of two or more units  cited by the IMMPACT  guidelines on outcome measures for pain trials . FurtherThe SubQStim study is a multicenter RCT comparing the clinical effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique plus optimized medical management (‘SQS arm’) versus optimal medical management alone (‘OMM arm’). Patients with back pain due to FBSS will be randomized to the SQS or OMM arms. Patients that fail to achieve the primary outcome  at 9 months post randomization will be allowed to switch treatments. All patients will be followed up for 36 months post randomization.The primary objective of SubQStim study is to compare the proportion of patients achieving the primary outcome at 9 months post randomization in SQS and OMM arms. Secondary objectives are to: (1) compare the primary outcome between SQS and OMM arms at 3 months and 6 months post randomization; (2) compare secondary outcomes  between SQS and OMM arms at 3, 6 and 9 months post randomization; (3) assess the value of trial stimulation in predicting 9-month post-randomization primary outcome response in the SQS arm; (4) assess the trend in device programming parameters up to 9 months post randomization; (5) assess within-patient changes  in primary and secondary outcomes from 9 to 36 months post randomization; (6) quantify the level of SQS-related and non-SQS related adverse events at all follow-up timings up to 36 months post randomization.Patients will be randomized 1:1 to peripheral nerve stimulation utilizing a subcutaneous lead implant technique plus optimized medical management (‘SQS arm’) or optimized medical management alone (‘OMM arm’) and followed for 9 months (period I: randomized comparative period). At 9 months after randomization, if patients in either arm fail to meet certain criteria (see below) they may switch treatment; that is, those in the OMM arm receive SQS or those in the SQS arm have their device turned off and/or explanted. Patients will be followed up until 36 months post randomization (period II: long-term follow-up period). The study design is summarized in Figure The SubQStim study will be conducted in specialized investigational centers. The principal investigator in each site will be experienced in implanting spinal cord stimulation systems and/or SQS systems or specializes in the diagnosis and ongoing treatment of back pain . It is anticipated that approximately 33 centers  will participate. No single center can exceed 15% of the total evaluable patients .The target population is patients experiencing intractable chronic back pain due to FBSS.At the screening visit, patients will be assessed to determine if they meet all of the inclusion criteria and are, therefore, eligible to participate in the study. Potential patients who meet any of the exclusion criteria will not be eligible to participate in the study.Inclusion criteria are: signed and dated the Patient Informed Consent/Patient Information Sheet prior to any study-related activities being conducted; ≥18 years of age at time of informed consent; minimum average back pain intensity of ≥50 mm assessed by VAS at screening visit; willing and available to attend visits as scheduled and to comply with the study protocol; willing and able to undergo assessments as part of the evaluation for eligibility and endpoints; willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol; diagnosed as having FBSS, that is, has had persistent pain for 6 months following most recent anatomically correct, successful surgery and there are no further therapeutic surgical options available as assessed by appropriate investigation; based on the opinion of the Principal Investigator, patient’s back pain is considered intractable and has been adequately treated, as defined by: failed an appropriate trial of at least three different classes of back pain treatments ; based on the opinion of the implanting physician, an appropriate implant candidate for the SQS system.Exclusion criteria are: has been or is being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system; leg pain score >30 mm assessed by VAS at screening visit; evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator; pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator; evidence of a spinal instability or anatomic compression that requires further surgery; spinal fusion at more than three vertebral levels; currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study; allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body; history of coagulation disorder or lupus erythematosus; involved in current litigation regarding back pain.Patients meeting the inclusion/exclusion criteria will complete a baseline diary questionnaire for 7 days. During the baseline diary, the subject must: (1) report an average back pain score ≥50 mm, (2) report an average leg pain score ≤30 mm, and (3) complete the diary for at least 5 days.Patients randomized to both arms will have their medical management optimized during the 9-month treatment period, beginning at randomization. Optimized medical management for each subject will be defined by the investigator. Optimized medical management does not include back reoperation or the implantation of medical devices . For example, this may include physiotherapy, transcutaneous electrical nerve stimulation, pharmaceutical treatments or acupuncture.Patients randomized to the SQS arm will undergo a test stimulation implant and an at-home trialing period. During the trialing period, patients will be programmed according to their optimal programming parameters and will be able to adjust their stimulation via the patient programmer, within the settings programmed by the physician. Prior to the permanent implant, all implanted patients will discuss the trialing period with the principal physician and complete a VAS for both back and leg pain. A stimulation trial is only considered successful if the following occurs: the patient agrees to proceed with the permanent implant and finds the feeling of paresthesia comfortable and has a pain reduction of ≥30% as measured by VAS or some reduction in pain as measured by VAS, along with improved function, and/or improved health-related quality of life, and/or a reduction in pain medications as assessed by the principal investigator. Given the lack of evidence of the predictive value of a stimulation trial , we chooThe following SQS-related equipment will be used in this study: The RestoreAdvanced®, PrimeAdvanced®, RestoreUltra®, and RestoreSensor® neurostimulators, 1 × 8 Standard and Quad Plus® leads ., and all current commercially available internal and external accessories approved for use for Peripheral Nerve Stimulation, and all future commercially available Medtronic neurostimulation devices, leads and accessories approved for use for Peripheral Nerve Stimulation.The investigator criteria to inform patient treatment switch after 9 months post randomization or later are as follows: if <30% pain relief on VAS: switchover is normally allowed without any further justification; if 30% to 50% pain relief on VAS: switchover is normally allowed if the patient has another reason for not responding to randomized arm, such as: no perceived improvement in quality of life, disability or medication use and/or side effects from treatments; if >50% pain relief on VAS: switchover is normally not allowed.Patients will be assessed prior to randomization (baseline) and at follow-up visits at 3, 6, 9, 12, 18, 24, 30 and 36 months post randomization. Assessments will require that patients visit the local investigational center and have their data collected via an electronic case report form. Table 0-VASV)/VAS0, where VAS0 is the average VAS at baseline visit and VASv is the average VAS at subsequent visits.The proportion of subjects with a ≥50% reduction in back pain intensity (VAS) from baseline to the 9 months post randomization. Patients will complete a pain diary, comprising a VAS scale, three times daily during the 7 days prior to their visit. The average VAS during that period will be calculated as the ratio between the sum of recorded VAS and the number of VAS measured. The percentage pain reduction will be calculated as 100* version 2  at all tAt the screening and baseline visits, the following additional information will be collected: patient demographics , neuropathic pain severity (Douleur Neuropathique en 4 Questions (DN4)),  mood  to provide 80% power in order to detect a 30% difference, and 85% power to detect a 25% difference (respectively), at 2-sided 1% alpha level. In order to ensure an overall alpha of two-sided 5%, the final analysis will be performed at two-sided 3% alpha . In ordeComputer generated random allocation schedules will be preprepared for each investigational center. The randomization schedule will be centrally held and allocation concealment will be maintained by an online database system that automatically assigns the patient to one of the two arms on confirmation by research nurse at the end of the baseline visit. The randomization schedules will be stratified to maintain a 1:1 balance between the treatment and control arm within each center and in the study as a whole. Patients will be randomized sequentially based upon randomization date and time.Given the nature of both the intervention and control treatments, it is unfortunately not possible to blind either patients, or clinicians.If a patient misses a study visit, the center’s study staff will make three attempts (one in writing and sent via a traceable method) to bring them in for a study visit. The numbers and reasons for dropouts and losses to follow-up will be reported by each arm of the study.All study deviations  will be recorded and the reasons documented.vice versa, will be included in this patient set. They will be analyzed according to treatment actually received.The intent-to-treat patient set (ITT) consists of all patients as they were randomized into the study. The per-treatment patient set (PT) consists of all patients of the ITT patient set for whom no major protocol deviation was reported. Patients who underwent a treatment switch, that is, who had initially been randomized to the OMM arm and switched to the SQS arm, or The primary effectiveness analysis will be based on a between group comparison of primary and secondary outcomes up to, and including, the 9-month visit using the ITT patient data set . For conSensitivity analyses will be undertaken using the same analytic models used in the primary analysis and based on the PT data set. In case of a discrepancy between the two analyses, a closer analysis of the data, of those patients from which the discrepancies result, will be performed. An additional sensitivity ‘modified ITT’ analysis will be performed for the primary outcome, considering patients randomized to the SQS arm but not definitively implanted as ‘failures’.In phase II of the study (beyond 9-month visit) the analytic focus will be a within-person approach, that is, comparison of primary and secondary outcomes at follow-up, relative to baseline. In addition, the percentage of subjects who switched treatments after the 9-month follow-up visit, and the time to switchover, will be compared between OMM and SQS arms.The study will seek to minimize missing data by conducting completeness checks on study data and patient questionnaires, with follow-up on any missing data. It is not possible to predict which will be the most effective method, therefore, we will undertake sensitivity analyses to examine different methods of missing data imputation, such as mean of nearby points (moving average), last value carried forward, doubly robust estimators or the best or the worst values that are not in favor of the SQS arm ,34.The ‘safety patient set’ consists of all patients of the ITT dataset, who started any of the study procedures independent of the treatment they had been randomized to. Complications and adverse events will be reported descriptively.All statistical tests will be interpreted at the two-sided α = 5% level and results reported as means and 95% confidence intervals. A more detailed exposition of study statistical analyses will be presented in a Statistical Analysis Plan to be completed prior to any data analysis.Economic analysis alongside the RCT will estimate the cost effectiveness of SQS plus OMM versus OMM alone. The primary economic endpoints will be the cost per quality-adjusted life-years (QALYs) gained, and cost per additional unit of change in the primary outcome . Primary economic analyses will be at 9-month follow-up, with secondary analyses comparing costs over longer-term follow-up. Cost-effectiveness analyses will be undertaken using the perspective of a third party payer, for example, health service provider/payer perspective.Within-trial data collection will inform estimates of intervention related resource, and resource use data will be combined with appropriate unit costs to estimate SQS intervention costs, in addition to OMM. Estimates of costs associated with other resource use will be informed by the HCU data collected within trial. Participant self-report data on EQ-5D-5 L  and SF-3Where analyses are conducted over a 12 month or longer time horizon, future costs and outcomes will be discounted at rates appropriate for country level analyses. Analyses of costs and outcomes will consider uncertainty in parameter estimates, assumptions , and limitations with the data, using extensive sensitivity analyses. The net benefit statistic will be used to present cost-effectiveness acceptability curves and confidence intervals on cost effectiveness against a range of estimates of willingness to pay per additional unit of outcome  ,37.Prior to enrolling subjects in this study, each investigation center’s Medical Ethical Committee will be required to approve the current study Clinical Investigation Plan and the Patient Information and Informed Consent Form. Any other written information to be provided to the subjects and, if applicable, any materials used to recruit subjects will also require ethical approval. Furthermore, such approval must be received in the form of a letter and provided to the study Sponsor (Medtronic Inc.) before commencement of the study at an investigation center.At each center, investigators must obtain written informed consent prior to subjecting patients to any study related activity.An independent Adverse Event Committee will review all adverse events. This Committee will consist of a minimum of three physicians independent of the Sponsor. The responsibilities of the Adverse Event Committee include, but are not limited to, the following: review all reported adverse events and their classification on a periodic basis; upon request, advise the Sponsor about the potential clinical impact of an observed, unintended device performance and cases of serious adverse device events.Finally, clinical monitors, as a representative of the Sponsor, will visit the principal investigators and/or subinvestigators and study centers at periodic intervals to ensure compliance to the investigational plan and study agreements, adherence to current International Organization for Standardization, Declaration of Helsinki regulations and standard operational procedures, and check accuracy of study data.RCTs have provided evidence to indicate spinal cord stimulation to be a clinically effective adjunct to medical management, and an alternative to a further operation for patients experiencing FBSS ,8. GivenNevertheless, while chronic leg (or radicular) pain can be effectively treated with SCS, this therapy is not always sufficient for chronic back pain. The existing trials of spinal cord stimulation in patients with FBSS, recruited individuals who presented with predominant leg pain and excluded those with predominant back pain ,8.Our systematic review identified 9 cases series studies of SQS in a total of 191 patients with chronic back pain. Importantly, these studies show that SQS implantation can result in clinically significant levels of pain relief in predominant back pain that is due to FBSS. The SubQStim study is the first RCT to assess the effectiveness and cost effectiveness of SQS in this patient population.The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014. It is anticipated that primary endpoint findings will be available in approximately 2016.CBLP: Chronic back and leg pain; CE: Conformité Européenne (European Conformity); DN4: Douleur Neuropathique en 4 Questions; FBSS: Failed back surgery syndrome; HADS: Hospital Anxiety and Depression Scale; HCU: Healthcare utilization; ITT: Intention to treat; LBP: Low back pain; MR: Magnetic resonance; ODI: Oswestry Disability Index; OMM: Optimal medical management; NSAIDs: Non-steroidal anti-inflammatory drugs; PGIC: Patient Global Impression of Change; PT: Per treatment; RCT: Randomized controlled trial; SF-36: Short-Form 36; SQS: Subcutaneous nerve stimulation; VAS: Visual analog scale; WHO: World Health Organization.SE, CG, MK, WP and RST have received consultancy fees from Medtronic. KW is a full-time employee of Medtronic.SE is the overall study principal investigator. All authors are member of the SubQStim Trial Steering Committee and have participated in the study conception and design. All authors contributed to the writing of the study protocol and the drafting and editing of this manuscript. All authors read and approved the final manuscript.Figure S1. Systematic review: summary of study selection. Table S1. Systematic review: quality assessment.Click here for file


Molluscum contagiosum is a common superficial skin infection caused by the poxvirus, Molluscum Contagiosum virus. The study objective is to obtain a better understanding of physician practices and experiences with molluscum contagiosum in order to focus informational and guidance material.A cross-sectional survey to assess medical practitioners’ knowledge and practices with molluscum contagiosum was conducted using the 2009 DocStyles survey. Questions regarding category and number of molluscum contagiosum patients seen, treatments used and advice given to patients were included in the survey.Dermatologists saw the most cases, with the majority seeing 51–100 molluscum contagiosum cases/year. The most common cases seen were children with multiple lesions and adults with genital lesions. Respondents were most likely to recommend treatment to immunocompromised individuals, HIV patients, adults with genital lesions and children with multiple lesions. Cryotherapy was the top choice for all specialties with the exception of OB/GYNs, whose top choice was curettage. “Avoid intimate contact until lesions resolve”, “Avoid touching lesions to reduce further spread”, and “Don’t be concerned, this will go away” were the top advice choices.Most survey respondents have dealt with molluscum contagiosum in their practice during the previous year. Overall, respondents picked appropriate choices for treatment and advice given; however some ineffective or unnecessary treatments were chosen and recommendations to prevent spread were chosen infrequently. Knowledge gaps for appropriate transmission precaution advice might cause unnecessary spread or autoinoculation. This survey has demonstrated that molluscum contagiosum is a common infection seen by many types of practitioners and therefore guidance on treatment considerations and infection control is valuable. Molluscum contagiosum (MC) is a common superficial skin infection caused by the poxvirus, Molluscum Contagiosum virus (MCV). MC is characterized by painless white or skin-colored papular skin-lesions that are generally 2 to 5 mm in size, though early lesions can be smaller. MC patients typically have 1–20 lesions, although even healthy patients may have a hundred or more lesions. MC, in normal hosts, is benign, limited to the skin, but lesions can take as long as 6–12 months to resolve MCV is spread via direct human-to-human contact and via fomites Treatment is not necessary for most cases of MC as lesions are generally self-limiting and resolve without scarring In an effort to obtain a better understanding of physician practices and experiences regarding MC, a cross-sectional survey was conducted using DocStyles, a web-based survey of primary care physicians and other specialties. Little research has been done on the types of MC patients physicians are likely to treat, the advice given, and treatment used. If appropriate transmission precaution advice were available to health care providers and their patients, additional spread and the costs associated with excess medical visits could be avoided. In addition, practical advice given to the families and schools of children with MC can help prevent needless exclusion from school or daycare. Restricting attendance can cause numerous problems for patients’ families as parents struggle to stay home from work or find alternative child care. Achieving a reduction in the use of unnecessary or ineffective treatments can help prevent avoidable pain and scarring in MC patients. Understanding physicians’ knowledge and familiarity with MC will help us focus informational materials, such as websites and pamphlets.www.porternovelli.com). The physician sample was drawn from Epocrates Honors Panel; an opt-in, verified panel of over 156,000 medical practitioners. Survey quotas were set to reach 1,000 primary care physicians, 250 pediatricians, 250 OB/GYNs, 250 dermatologists, 250 nurse practitioners, and 150 registered dietitians. Verification was achieved by checking each physician’s first name, last name, date of birth, medical school, and graduation date against the American Medical Association’s master file at the time of panel registration. Epocrates randomly selected a sample of eligible physicians from their main database to load into their invitation database. This sample was drawn to match AMA master file proportions for age, gender, and region. The registered dietitian and nurse practitioner samples were drawn from Epocrates’ Allied Health Panel of 473,000 health professionals, which includes 44,523 nurse practitioners and 1,587 dietitians. Responses from registered dietitians were not used for this study. All invitations included a link to the Web-based survey, which was hosted by ResearchNow. Respondents were paid an honorarium of $55–$95 for completing the survey.A cross-sectional design was used to survey physicians and other medical practitioners on current knowledge and practices regarding MC. The 2009 DocStyles survey was used for this study. DocStyles is a yearly survey of physicians and other specialties conducted by the public relations firm, Porter Novelli , etc.). All questions were in a multiple-choice format with no option for free-text answers. In addition, personal characteristics such as sex, age, race/ethnicity, and professional characteristics, including type of practice and number of patients seen per week, were provided.Basic frequencies were calculated for the types of MC cases seen during the last one year. Frequencies for the number of MC cases seen in the last one year and for the types of MC cases recommended for treatment were stratified by health care provider specialty. Logistic regression modeling was used to estimate the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for the types of treatment used and the advice given to MC patients adjusting for several variables. Physician characteristic variables adjusted for in this analysis include age (<40 (reference), 40–49, >50), sex, race (categorized into White (reference), African American, Asian, Other), specialty , Internist, Pediatrician, OB/GYN, Dermatologist, Nurse Practitioner), number of patients seen per week (≤50 (reference),51–100,101–150, >150), and type of practice , Group Practice, Hospital or Clinic). Data analysis was performed using SAS v9.3.A total of 2000 respondents were included in the survey, excluding registered dieticians. Those who answered “Not applicable to my practice” when asked about advice given to MC patients were also excluded (n = 308). The majority of respondents were family/general practitioners (30.45%), white (76.9%), male (61%), and work in a group practice (63.55%) . Of thesOverall, respondents were most likely to recommend treatment for molluscum cases in immunocompromised and HIV patients followed by adults with genital lesions and children with multiple lesions in one area . RespondDermatologists were over 3 times more likely to discourage over-the-counter medications or homeopathic remedies  and pediatricians were almost 5 times more likely to refer patients to a dermatologist  compared to family/general practitioners . Nurse pCryotherapy was the top treatment choice for all physician specialties with the exception of OB/GYNs, whose top choice was curettage . InterniWhen asked about the advice they would give to a molluscum patient, “Avoid intimate contact until lesions resolve”, “Avoid touching lesions to reduce further spread” and “Don’t be concerned, this will go away” were the overall top picks . Only 11.8% of all respondents selected “Cover lesion with bandage”. Pediatricians were more likely to choose “Don’t be concerned, this will go away” and less likely to choose “Avoid school until the lesions resolve”, “Wash hands frequently”, “Disinfect household surfaces”, and “Don’t let others touch patient’s towels and sheets” when compared to general practitioners . Older pMolluscum contagiosum is a common skin infection. Most of the practitioners who participated in the survey had dealt with the condition in their practice during the previous year. The bulk of respondents in the survey reported having seen between 1 and 10 cases in the last year. Pediatricians and dermatologists in this survey reported the most experience with MC cases, having seen an average of 11–50 and 51–100 cases, respectively, during the year prior to the survey. The considerable number of cases seen by pediatricians in this survey is consistent with prior reports of elevated MC incidence rates in young children Overall, health care providers were most likely to recommend treatment for immunocompromised patients, patients with HIV, adults with genital molluscum, and children with multiple lesions in one area. They were less likely to treat children with one or widely scattered lesions, which coincides with current recommendations (16). In contrast, dermatologists reported a greater readiness to treat MC regardless of the age of the patient or concurrent medical disorders such as HIV or other immunocompromising conditions. A possible explanation for this finding could be that cases are usually referred to a dermatologist by their primary physician specifically for the purpose of treatment. It is also possible that patients who seek care from a dermatologist may be experiencing a less benign manifestation of infection that might require treatment, or they may have lesions that are visible or cause embarrassment. Another explanation might be that dermatologists see so many patients with extensive MC that many believe treatment is worthwhile, even when the patient has minimal lesions. Dermatologists are equipped to routinely remove these types of lesions and therefore may be more inclined to do so.Cryotherapy and curettage are the top choices for treatment for all health care providers and have been shown to be somewhat effective. However, these techniques can cause scarring, hypo or hyper pigmentation, and can be painful, especially for children Most health care providers picked appropriate choices for advice given to MC patients. The top advice from family/general practitioners and pediatricians of “Don’t be concerned, this will go away” is helpful to ease the patient and the patient’s family’s concern about this infection and possibly prevent unnecessary treatment. The top choice for internists, OB/GYNs and dermatologists is “Avoid intimate contact until lesions resolve”. This advice and another top pick, “Avoid touching lesion to reduce further spread”, are effective for preventing spread to others and autoinoculation. Some of the Centers for Diseases Control and Prevention’s (CDC) recommendations  to prevePhysicians over the age of 50 were less likely to recommend effective advice such as “Cover lesion with a bandage or dressing”, “Wash hands frequently”, “Avoid touching lesion to reduce further spread”. They were also more likely to offer advice that may be considered ineffective or detrimental, such as “Scratch lesion to promote inflammation and healing”. While there have been claims of scratching as a potential for helping lesions resolve, it is not recommended as it can cause autoinoculation and spread to others. A common query to the CDC hotline made by patients’ families and schools is whether a child with MC should attend school (unpublished data). MC is benign and can take months to resolve, therefore excluding children from school is considered excessive and unnecessary. Very few health care providers picked “Avoid school until the lesions resolve (children)” for advice offered.Knowledge gaps for appropriate transmission precaution advice might cause unnecessary further spread or autoinoculation. In addition, unnecessary exclusion of children with MC from school or daycare can cause many problems for families. If appropriate transmission advice was provided to these children’s families and schools, the stresses of parents taking off work and losing income or finding alternative child care could be prevented. While the appropriate advice was chosen more often than inappropriate advice, the percent respondents was low for most of the survey choices, including those which CDC recommends for transmission precautions .Overall, survey respondents were able to choose appropriate treatments and advice for MC patients. The survey revealed some potentially unnecessary or ineffective treatment choices for MC patients. MC, in a normal host, is benign and treatment is often unnecessary and can cause unwanted side effects. However the persistence of lesions may influence practitioners’ treatment plans. Respondents were generally able to provide appropriate hygiene advice to MC patients. Increased educational materials would be helpful to reinforce the recommendations to prevent spread to others and prevent autoinoculation. A better understanding of why non-standard advice is given will help to focus educational materials. Prevention of MC spread and autoinoculation can decrease anxiety and relieve burden of patients and physicians. Uniformity of recommendations and emphasis on low-cost, low-risk therapies and interventions would be beneficial as well. This survey has demonstrated that MC is a common skin infection seen by many types of health care providers and therefore guidance on treatment considerations and infection control is valuable.


Object. We arranged a mini-invasive surgical approach for implantation of paddle electrodes for SCS under spinal anesthesia obtaining the best paddle electrode placement and minimizing patients' discomfort. We describe our technique supported by neurophysiological intraoperative monitoring and clinical results. Methods. 16 patients, affected by neuropathic pain underwent the implantation of paddle electrodes for spinal cord stimulation in lateral decubitus under spinal anesthesia. The paddle was introduced after flavectomy and each patient confirmed the correct distribution of paresthesias induced by intraoperative test stimulation. VAS and patients' satisfaction rate were recorded during the followup and compared to preoperative values. Results. No patients reported discomfort during the procedure. In all cases, paresthesias coverage of the total painful region was achieved, allowing the best final electrode positioning. At the last followup (mean 36.7 months), 87.5% of the implanted patients had a good rate of satisfaction with a mean VAS score improvement of 70.5%. Conclusions. Spinal cord stimulation under spinal anesthesia allows an optimal positioning of the paddle electrodes without any discomfort for patients or neurosurgeons. The best intraoperative positioning allows a better postoperative control of pain, avoiding the risk of blind placements of the paddle or further surgery for their replacement. Spinal cord stimulation (SCS) is a widely established therapy for chronic neuropathic pain , 2. ThisAt the beginning, the stimulation was delivered using paddle electrodes inserted by means of a surgical operation, but in the early '70s percutaneous spinal catheter leads were developed. These two techniques are both still used, but with different indications. The percutaneous leads are less invasive and they are implantable under local anesthesia. The possibility to keep the patient awake enables the surgeon to verify the coverage of the painful areas “online”, asking directly the patient about the paresthesias distribution and thus achieving the optimal placement of the electrodes.Anyway, paddle electrodes are, from several points of view, considered the best choice for patients who are responders to percutaneous SCS and for those who experimented catheter-leads displacement and/or misplacement. The shape of paddle electrodes offers a greater stability, decreasing the risk of migration , 7. MoreThe paddle electrode placement process is commonly performed under local anesthesia in order to obtain the best positioning. Unfortunately, this procedure often results very stressful and painful for patients . AlternaOther authors proposed spinal anesthesia to decrease the discomfort associated to the implantation under local anesthesia thus avoiding the risks of incorrect positioning of the paddle electrodes . They obWe adopted this technique, improving the minimal invasive spine approach. Clinical outcome over a long-term followup, surgical results, and details of our technique are here provided in order to suggest an original, reliable, and effective approach.From January 2005 to February 2010, we selected 16 paddle electrode implantations under spinal anesthesia. All the patients have a history of neuropathic pain due to different causes, which irradiate to one or both inferior limbs, nonresponsive to the conventional therapies   7, 10]., 10.7, 1For each patient the Visual Analogue Scale (VAS) score was recorded before surgery. Further assessment of VAS was obtained during the followup. Scores at the last followup were compared to preoperative results . For each patient, the satisfaction rate was recorded during the follow-up period asking them to choose among little (0–50% pain relief), rather good (51–75%), good (76–90%), or total (91–100%). Finally, the rate of pain area coverage  was recorded during all the follow-up period to recognize possible displacement of the leads or malfunction of the implant.All the patients subscribed a detailed informed consent, according to the procedure evaluated and accepted by the S. Anna University-Hospital Institutional Accreditation Committee and conformed to the standards set by the 1964 Declaration of Helsinki.Intrathecal injection of hyperbaric Bupivacaine (15–20 mg) at the L2-L3 level was administrated for spinal anesthesia. The site of incision was deeply infiltrated with 10 cc of Mepivacaine (2% solution) in order to avoid postsurgical pain due to the scar tissue. The level of anesthetization of the region was careful assessed using traditional methods, such as pinch and pinprick.After spinal anesthesia administration, the patients were positioned on the operating table in lateral decubitus. The intervertebral space chosen for the electrode paddle insertion was evidenced under fluoroscopic guide  .We performed a median incision followed by bilateral skeletonization of the intervertebral space selected. After the resection of the supraspinous and interspinous ligaments, the upper spinous process was only partially resected. We did not provide any laminectomy, but we reached the epidural space by means of flavectomy. We introduced the paddle electrode into the epidural space and gently pushed it in a cephalad direction, by means of the guide.Once the paddle electrode was positioned into the epidural space, we connected the extremity of the external lead to the external test stimulator, by means of a screening cable. The test stimulation started and patients were asked to confirm the complete paresthesias coverage of the painful areas. The paddle position was eventually modified, according to the patients' sensations. Stimulation usually started with a gradual increasing of amplitude. We never needed amplitudes over 4 V to evoke paresthesias.In one case we also used intraoperative monitoring to evaluate the neurophysiological effects of spinal anesthesia and test stimulation.Cortical-somatosensory-evoked potentials (SEPs) were obtained by stimulation of both tibial nerves of the ankle, alternately, via bipolar surface electrodes, and by bipolar stimulation from a spinal epidural grid . The cortical signals were continuously recorded by subcutaneous needle electrodes at the scalp in position Cz′ and at Fpz as reference (10–20 system). The potentials were filtered (bandpass 3 Hz–5 KHz), averaged (200 stimulus responses), and recorded for 100 msec after stimulus onset. Peripheral motor-evoked potentials (MEPs) and epidural-motor-evoked potentials (D-Wave) were obtained by magnetic motor cortex stimulation via eight coils positioned at the vertex of the scalp in the hot spot position and with adequate intensity for maximal responses of the tibial muscles. The epidural responses were collected by means of bipolar recordings via SCS grid. The peripheral signals were recorded by means of bipolar surface electrodes at the tibial muscle, bilaterally and continuously. The potentials were filtered (bandpass 3 Hz–5 KHz) and recorded for 50–100 msec after stimulus onset. All neurophysiologic data were performed with an electrodiagnostic system .In our Institution, all the paddle electrodes were anchored perforating the spinous process of the inferior vertebra and securing the lead bodies to the spinous process, by means of 2-0 nonreabsorbable wires.Further 5 cc of local anesthesia (Mepivacaine solution at 2%) was administrated along the tunneling route of the temporary extensions, approximately 3 cm below the surgical incision, also in this case to avoid postsurgical pain. The skin incision was then irrigated with Betadine-soaked gauzes and closed by layers, using absorbable sutures (Vicryl) for the subcutaneous tissues and nylon sutures for the skin.The IPG position was chosen in agreement with the patients considering weight, fat distribution, and previous surgeries. However, we prefer to locate the pulse generator in an abdominal wound, especially in overweight patients.A 5 cm skin incision is made and a subcutaneous pocket is created, above the muscle fascia. The IPG should not be deeper than 2 cm from the skin surface, especially if rechargeable IPG is used. In slim patients, a subfascial placement of the pulse generator may be desired for better cosmetic results. The leads were connected to the IPG, which was tested by external remote checking of the electrode impedances. The wound was then irrigated with Betadine-soaked gauzes and closed by layers using absorbable sutures for the subcutaneous tissue and nylon sutures for the skin. Appropriate dressings covered all the wounds.In all the procedures, analgesia was complete and effective, without interfering with the intraoperative monitoring of the paresthesia coverage.As showed by neurophysiological monitoring , we observed the disappearance of short latency SEPs and cortical-evoked responses after tibial nerve stimulation, but we reported their preservation after intraoperative direct SCS somatosensory stimulation. This observation is also completed by the persistence of epidural D-waves after motor cortical stimulation and by the absence of peripheral motor responses after the same intraoperative motor cortex stimulation, as reported by other Authors, too .The comparison between the preoperative and the last followup, Visual Analogue Scale (VAS) demonstrated a very good control of neuropathic pain by SCS in long-term periods. In our population, the mean VAS improvement was 70,5%, passing from a mean preoperative VAS value of 8,3 (range 7–10) to a mean postoperative value of 2,5 (range 1–7). Only two patients . During the follow-up period, patient No. 10 experimented a subtotal coverage of the pain area although radiographic imaging excluded displacement or breakage of the paddle electrode and checking impedances of circuit were also verified.We had no complications in any but one patient, who developed a severe right leg paresis caused by an epidural hematoma that required an emergency intervention. After the hematoma evacuation, the patient recovered from all the symptoms and the paddle electrode was left in situ.At the last followup no, patients needed new surgical procedures for miss or displacement of the electrode.Chronic pain has an outstanding impact on a patient's quality of life. It interferes with his/her physical function and psychological well-being is often hindered. Moreover, chronic pain has been a well documented burden on our health care system, as well as on our social economy. Between 10 to 40% of patients who underwent lumbosacral spine surgery to alleviate pain, turned out to have persistent or recurrent chronic pain , 13, theIn selected patients with FBSS, treatment with SCS results in pain relief, sustained at a long-term followup and associated to patients' satisfaction and to important clinical improvements in their functional capacity and health-related quality of life , 14, 15.The implantation of paddle electrodes requires a laminotomy and in many centers this procedure is performed under local anesthesia, which allows paresthesias coverage monitoring. This approach, however, is stressful, often painful and not well tolerated by some patients. Alternatively, the placement of such electrode systems can be performed under general anesthesia, definitely precluding the use of intraoperative test stimulation. The use of peripheral responses, evoked by SCS and interpreted as antidromic nerve activity, has been suggested to assess the optimal location of the electrode .We experienced the use of spinal anesthesia for paddle electrode implantation with success, minimizing the discomfort for patients. The local anesthetic deposited into the subarachnoid space, in fact, produced complete motor block and anesthesia but did not seem to block all sensory transmission in the superficial layers of the spinal dorsal columns . Therefore, an intraoperative test of paresthesias distribution, guiding the lead positioning, is possible. Our data demonstrate that SCS can produce paresthesias for the intraoperative stimulation test even though spinal anesthesia coverage is completely effective in the control of pain. Our neurophysiological and clinical data seem to support a major involvement by anesthesia of the spinal roots and ganglia in respect to the coarse fibers of the dorsal columns . SomatosThe lateral position, turned out to be comfortable for awake patients and it does not increase the duration of surgery nor does it produce any kind of problems in gaining access to the spinal canal for surgeons. Furthermore, the minimal demolition we propose (strictly limited to flavectomy) allows the surgeon to avoid laminectomy, in order to minimize the risk of spinal instability also reducing the duration of surgery. This conservative surgical approach is reliable thanks to the flexibility of the plastic electrode. However, during flavectomy, much attention has to be paid to avoid the presence of bony splinters, so the paddle won't be damaged.We are also used to anchor the lead bodies to the inferior spinous process in order to avoid the dislocation of the paddles. The effectiveness of this procedure is not largely approved but resulted effective to avoid displacements in our case series. In our study, the stimulation intensity required to evoke paresthesias during spinal anesthesia was only moderately higher than the amplitude needed in normal conditions. However, this difference from other studies on SCS under spinal anesthesia does not necessarily reflect a difference in the depth of analgesia, but may be the result of better electric conduction properties of the much larger and unidirectional stimulating poles of the paddle electrodes compared to catheter leads .Our experience definitely suggests the safety and the effectiveness of the spinal anesthesia in providing the best positioning of electrodes for SCS. This kind of anesthesia provides a good analgesia without modifying the paresthesias perception, as showed in our case study. The opportunity to check the distribution of paresthesias in an intraoperative way allowed us the best positioning of the electrode; all our patients confirmed total pain area coverage during intraoperative stimulation. We have reached this goal, as confirmed by the good results in the control of pain carriers in our centre. The mean VAS improvement at long-term followup  remains remarkable  with 87,5% of our population (14/16) characterized by a good rate of satisfaction.Only two patients, in fact, did not reach a clinical success (defined as VAS improvement > 50%). One of them (No. 10, see Nevertheless, the patient selection definitely remains the most important prognostic factor for good outcome, especially when considering the real etiology of neuropathic pain, the psychological status, and patients' compliance to this kind of treatment.Our case series confirms the previous evidence about the safety and the effectiveness of spinal anesthesia for pain control, without creating any interference during intraoperative stimulation. The lateral position resulted comfortable for patients and feasible for surgeons. Flavectomy represents the most conservative surgical technique for the implantation of this kind of electrodes. Finally, we consider this procedure as the most effective in achieving a finer positioning of the paddle electrode, avoiding “blind placements”.


Thoracic surgeries including thoracotomy and VATS are some of the highest risk procedures that often lead to CPSP, with or without a neuropathic component. This retrospective study aims to determine retrospectively the prevalence of CPSP following thoracic surgery, its predicting risk factors, the incidence of neuropathic component, and its impact on quality of life.Patients who underwent thoracic surgeries including thoracotomy and VATS between 01/2010 and 12/2011 at the First Affiliated Hospital, School of Medicine, Zhejiang University were first contacted and screened for CPSP following thoracic surgery via phone interview. Patients who developed CPSP were then mailed with a battery of questionnaires, including a questionnaire referenced to Maguire's research, a validated Chinese version of the ID pain questionnaire, and a SF-36 Health Survey. Logistic regression analyses were subsequently performed to identify risk factors for CPSP following thoracic surgery and its neuropathic component.The point prevalence of CPSP following thoracic surgery was 24.9% (320/1284 patients), and the point prevalence of neuropathic component of CPSP was 32.5% (86/265 patients). CPSP following thoracic surgery did not improve significantly with time. Multiple predictive factors were identified for CPSP following thoracic surgery, including age<60 years old, female gender, prolonged duration of post-operative chest tube drainage (≥4 days), options of post-operative pain management, and pre-existing hypertension. Furthermore, patients who experienced CPSP following thoracic surgery were found to have significantly decreased physical function and worse quality of life, especially those with neuropathic component.Our study demonstrated that nearly 1 out of 4 patients underwent thoracic surgery might develop CPSP, and one third of them accompanied with a neuropathic component. Early prevention as well as aggressive treatment is important for patients with CPSP following thoracic surgery to achieve a high quality of life. A surgical incision produces tissue injury, inflammation, and subsequent acute post-operative pain. Subsequent modulation of the peripheral and central nervous system can lead to chronic pain. Acute pain management including multimodal analgesia techniques aspires to stop the transition from acute pain to chronic pain, yet a significant reduction in the occurrence rate and severity of chronic pain has not occurred Thoracic surgeries including thoracotomy and video-assisted thoracoscopic surgery (VATS) are some of the highest risk procedures that often lead to chronic post-surgery pain (CPSP) In spite of the devastating nature of CPSP, the current understanding of CPSP following thoracic surgery and its potential neuropathic component remains poor. Based on the diagnosis criteria from the International Association for the Study of Pain (IASP) This study aims to investigate the prevalence of CPSP following thoracic surgery and its neuropathic component, to identify risk factors, and to determine the effect of chronic pain on HRQOL following thoracic surgery. This information may be used to reduce the incidence of CPSP following thoracic surgery, guide the optimal post-operative pain management, and ultimately improve patients' qualify of life.The study was approved by the ethics committee of the First Affiliated Hospital, School of Medicine, Zhejiang University. All subjects in this study were given verbal informed consent for their participation and the oral informed consent process was approved by the research ethical committee of the Department of Anesthesiology at the First Affiliated Hospital, School of Medicine, Zhejiang University. All participants received written information about the survey prior to the obtained consent. Written consent was deemed impractical in this large low risk survey and verbal consent was obtained by the interviewers and audited by the Department of Anesthesiology at the First Affiliated Hospital, School of Medicine, Zhejiang University.A retrospective questionnaire survey was undertaken on patients who had undergone thoracotomy and VATS between 01/2010 and 12/2011 at the First Affiliated Hospital of School of Medicine, Zhejiang University, China. Criteria for exclusion include: age <18 years old, history of pre-operative chemotherapy, history of previous thoracic surgery, history of neurological disorders or thoracic trauma, emergent operation, and surgical site infection. The survey was conducted between 3/2012 and 6/2012, more than 3 months after the initial surgery. A total of 1624 patients were identified and contacted.According to the IASP The ID Pain questionnaire is a six-item, patient-completed screening tool designed to help differentiate nociceptive and neuropathic pain. Patients scoring greater than or equal to 2 on a Chinese version for ID pain questionnaire are considered to have neuropathic component The HRQOL was measured using a Chinese version of SF-36, which is a standardized and validated tool and has been widely used to evaluate patient's health. The SF-36 assesses eight scales: physical function (PF), role limitations due to physical problems , body pain (BP), general health (GH), vitality (VT), social function (SF), role limitations due to emotional problems , and mental health (MH). The raw scores of each subscale were converted to a range from 0 to 100, with higher scores indicating better levels of functioning or well-being.A total of 1624 patients were contacted. Patients with CPSP following thoracic surgery were identified if they answered yes to both of the following questions: 1) “Have you experienced any pain along the scar after surgery, different from what you had before the surgery?” 2) “Has the pain persisted for at least 3 months?”. Patients were then asked for permission to mail them a battery of questionnaires, including a questionnaire referenced to Maguire's research To identify potential risk factors for CPSP following thoracic surgery, patient demographics, past medical history, and clinical characteristics including anesthesia, surgery, and peri-operative pain management were collected from the electronic medical records system. Similar to a previous investigation Four different surgical teams were involved in this study, with both thoracotomy and VATS. The thoracotomy approach used a conventional protocol without rib resection during the operation. Skin incision was parallel to the ribs at the lateral or posterior-lateral part of the intercostal space. After placement of an intercostal chest tube , the intercostal space was closed by pericostal sutures with extreme precautions applied to avoid the injury of intercostal nerves. The VATS approach used a uniform anterior three-port technique with standardized port placements regardless of the lobe to be resected or not. The camera port was made in the 7th inter-costal space at the middle axillary line, while the main port was placed in the 4th inter-costal space at the anterior axillary line, and the third port was placed in the 9th inter-costal space at the posterior axillary line. At the end of surgery, a draining chest tube  was inserted in the Camera port. The draining chest tube was removed as soon as no air leakage was detected for more than 24 hours, total amount of pleural effusion was less than 200 ml per day, and no chylothorax was present.A total intravenous anesthesia (TIVA) technique composed of propofol, fentanyl or remifentanil, and intermittent rocuronium was used to maintain adequate anesthesia after induction. No paravertebral or epidural block was administrated preoperatively.Under the current State Health Insurance Policy in Mainland China, cost related to PCA pump is not reimbursable. Many patients opted to choose the non-PCA regimen due to their willingness and capability for self-pay. As a result, 833 patients in our study chose PCA regimen for post-operative pain management. The PCA regimen included a patient controlled infusion pump  programmed to deliver sufentanil with a continuous dose of 1–2 micrograms per hour, along with patient controlled bolus of 2–3 micrograms at a lockout interval of 10 minutes. The bolus dosage was subsequently adjusted and titrated for optimal analgesia  score less than 3). In addition, patients received intravenous Flurbiprofen at 50 mg every 12 hours for total 3 days, unless contradicted due to bleeding concerns or renal insufficiency. The non-PCA regimen included intravenous Flurbiprofen at 50 mg every 12 hours and tramadol 100 mg intramuscularly every 6 hours as needed (when VAS score more than 7). Those non-PCA option patients were managed by surgical teams from the Department of Thoracic Surgery, in contrast to the patients with PCA option who were managed by a dedicated Acute Pain Service (APS) team from the Department of Anesthesiology.t test with normal distribution and by the Mann-Whitney U test for variables with non-normal distribution. The Chi-square test was used to compare groups with categorical variables. P value less than 0.05 was considered significant. Univariate analyses and multiple forward stepwise logistic regression analyses were performed to identify risk factors predicting CPSP following thoracic surgery and its neuropathic component. After univariate analyses, variables with p value less than 0.05 were included in a multivariate logistic regression analysis to identify the independent factors of CPSP following thoracic surgery and its neuropathic component.Data was analyzed using SPSS 16.0 software . Continuous variables were presented as mean ± standard deviations and categorical data were shown as numbers and percentages. Comparison of continuous data was performed by Student's As shown in the overall flow diagram of At the time of phone interview, the point prevalence of CPSP following thoracic surgery was 24.9% (320/1284 patients). Those 320 patients were then mailed with the questionnaire referred to Maguire's research to further explore the nature of chronic pain. 265 patients subsequently sent back the form, of which the point prevalence of neuropathic component of CPSP following thoracic surgery was found to be at 32.5% (86/265 patients). To assess the properties of chronic pain, the questionnaires referred to Maguire's research were sent to 320 patients with CPSP following thoracic surgery, and 265 replies were sent back. Among them, 73.5% of patients reported their pain being mild, 22.3% moderate, and only 4.2% severe. The most frequent descriptions of the pain include dull, throbbing, pressure, rebound tenderness, and needle-like and electric shock-like sensations around the surgical site and the chest tube placement sites. In addition, 67.3% patients did not feel improvement in their pain over time, while 25.7% reported that the pain was worse, especially when there is a rapid weather change, including cloudy or rainy days.p<0.05), as well as statistically significant increases in the incidence of unpleasant skin sensation (p<0.05), hyperalgesia (p = 0.013), and skin temperature change (p = 0.021)Significant differences were noted in terms of pain characteristics between CPSP patients with and without neuropathic component . CPSP fop<0.05). In addition, women  experienced more CPSP following thoracic surgery than men . CPSP prevalence in patients who had medical history of hypertension was also significantly higher than those without hypertension (p<0.01). The prevalence of CPSP in patients who were offered post-operative PCA based pain management was significantly less than those patients who did not receive PCA (p = 0.035). Finally, duration of chest tube drainage (≥4 days) was found to be a significant risk factor for CPSP after thoracic surgery (p<0.01).No statistically significant difference was found between the CPSP group and non-CPSP group including ASA physical status, history of smoking, past medical history of diabetes, diagnosis of cancer, type of procedure (thoracotomy versus VATS), and the duration of the procedure . In addiBased on logistic regression analysis, risk factors for developing chronic pain after thoracic surgery include age below 60 years old , female gender , hypertension , lack of PCA for post-operation analgesia , and prolonged duration of chest tube drainage (≥4 days) .p<0.05, OR: 0.421, 95% CI: 0.187–0.952).Logistic regression was also used to determine the risk factor for neuropathic pain occurrence in patients who developed CPSP following thoracic surgery, including age, gender, ASA physical status, type of surgery, medical history of hypertension or diabetes, type of cancer, adjunct radiation and chemotherapy, number of chest tube drains, and duration of chest tube drainage. Interestingly, only the duration of chest tube drainage (≥4 days) was identified to correlate (positively) with neuropathic pain (p<0.05). Interestingly, there was no significant difference in the proportion of patients with or without neuropathic component, in terms of visit to pain clinic and seeking additional pain medications (p>0.05).As shown in p<0.05). In addition, compared to CPSP patients without neuropathic component, there was a significant decrease in PF for CPSP patients with neuropathic component (p<0.05).In order to confirm whether CPSP following thoracic surgery and its neuropathic component negatively impacts quality of life, SF-36 Health Survey (Chinese version) questionnaires were mailed to both CPSP patients and non-CPSP patients (n = 600). Total 467 replies were received, among which 202 were non-CPSP patients, 179 were CPSP patients without neuropathic component, and 86 patients were CPSP patients with neuropathic component, respectively . CompareOur study found that one out of four patients undergoing thoracic surgery would develop characteristics consistent with persistent post-thoracic surgery chronic pain (CPSP), with one third of them reporting signs and symptoms consistent with neuropathic pain. Furthermore, our study has identified multiple risk factors for the development of CPSP following thoracic surgery, including age<60 years old, female gender, preoperative hypertension, post-operative non-PCA pain management regimen, and prolonged duration of post-operative chest tube drainage (≥4 days). In addition, the duration of post-operative chest tube drainage (≥4 days) was the only variable found to play a role for development of CPSP with neuropathic component. In our study, patients with CPSP have much worse quality of life, especially those with neuropathic component, suggesting the importance of preventing CPSP from development following thoracic surgery, as well as the need for aggressive treatment once it has developed. To our knowledge, this is the first study to investigate the prevalence of CPSP and its neuropathic component after thoracic surgery using a combined validated Chinese version of the ID pain questionnaire and a Short Form-36 (SF-36) Health Survey.The reported prevalence of CPSP following thoracic surgery varies from 14% to 83% In contrast, the prevalence of CPSP following thoracic surgery with a neuropathic component identified from our study (32.5%) is similar to findings in literatures Although most of the patients who undergo thoracic surgery will experience some tissue and nerve injuries, not all will develop CPSP following thoracic surgery. A number of studies have attempted to identify potential risk factors for the development of CPSP and its neuropathic component, but come to variable results Our study also for the first time demonstrated that pre-operative hypertension is a risk factor for CPSP following thoracic surgery. It is well known that there are adverse physiological effects of acute pain on cardiovascular systems by increasing sympathetic activity and stress response, which could be further exaggerated in hypertensive patients.The trajectory for CPSP following thoracic surgery is not clear. Consistent to Steegers et al Intercostal nerve damage is well known as a main cause of CPSP following thoracic surgery Based on the SF-36 scores combined with scores from questionnaire referenced to Maguire's research, our study has found that CPSP patients in general have mild symptoms, with similar overall health vitality and mental health compared to patients who did not develop CPSP, though CPSP patients do have increased pain intensity and decreased physical functioning. Few CPSP patients needed to take pain medications. In contrast, the presence of neuropathic symptoms was associated with more severe pain, decreased daily activity, poorer sleep, and overall worse quality of life, which are consistent to findings from Steegers et al The retrospective study design is a limitation, and the shortcomings of self-reported pain on phone interview and in questionnaire surveys need to be kept in mind. We also could not rule out tumor recurrence and metastasis at the time point of phone interview and paper survey, which could complicate pain presentation. In addition, this is a single-center study; additional data from multi-center studies will be needed to verify our findings. Other potential risk factors including preoperative psychosocial comorbidity and genetic predisposition were omitted in this study as they could not be assessed or measured in retrospective study. Future studies are needed to address these limitations with well designed protocol Chronic pain is a common complication from thoracic surgery, which can significantly impact patient's daily life. Our study showed that about one out of four patients who received thoracic surgery will develop persistent post-thoracic surgery chronic pain, with about one third of them has neuropathic component. There are several predicting risk factors identified from our study, of which the duration of chest tube drainage (≥4 days) seems to be essential for both CPSP following thoracic surgery with and without neuropathic component. Patients with the neuropathic component have significantly worse quality of life, suggesting the importance of preventing CPSP following thoracic surgery from developing as well as aggressive treatment of CPSP once it has developed. Further studies are needed to investigate the impact of minimizing risk factors on the incidence of CPSP, especially a multifaceted approach to shorten the chest tube drainage.


Hemicrania Continua is an indomethacin sensitive chronic primary headache syndrome consisting of constant unilateral pain with severe cranial autonomic exacerbations. Long-term indomethacin use can be associated with side effects, resulting in discontinuation of the drug in some patients. Current neuromodulation approaches to treatment, including occipital nerve stimulation (ONS), all require surgical implantation. A novel alternative treatment for this disorder is therefore needed.We assessed the usefulness of a new non-invasive, portable vagus nerve stimulation (VNS) device, the GammaCore, in two patients who were unable to take indomethacin. Both had previously responded to ONS with the Bion implant, but hadPatient 1  had been using the device both prophylactically and acutely for 24 weeks at last follow up, with an overall improvement in his baseline condition, estimating a 30% improvement in background pain and 20% improvement in painful autonomic exacerbations. Acutely the device was able to abort exacerbations within 15 minutes most of the time, and it significantly improved the pain for the remainder of attacks. He felt satisfied with the device, although did not feel it was as helpful as the Bion implant.Patient 2  had been using the device following an exclusively prophylactic regimen for 32 weeks at last follow up, with an overall improvement in her baseline condition, estimating a 75% improvement in both background pain and painful autonomic exacerbations. She felt very satisfied with the device and felt it to be superior to the Bion implant.Both would recommend non-invasive VNS to other patients.This is the first evaluation of an entirely new treatment modality for hemicrania continua, which may offer a non-invasive neurostimulation alternative in selected patients.Further work is needed to establish this efficacy in a larger series of patients.This work was supported by an unrestricted grant from ElectroCore Medical, LLC.


Intravenous acetaminophen (IVA) has rapid and effective analgesic properties. Recent studies have shown several benefits of using IVA perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use IVA in the perioperative period. This brief review examines the utility of this medication in the perioperative period and highlights future areas of clinical and epidemiological research regarding its use. Intravenous acetaminophen (IVA), or paracetamol, was made available in Europe in 2002, but only approved for use in the United States in November of 2010. IVA has both rapid and effective analgesic properties and is considered to be safe and well tolerated  than when ingested orally, making IVA a safer alternative. Intravenous infusion produces a peak acetaminophen concentration in the liver estimated to be 50% less than the same oral dose  on postoperative day one after total hip replacement or total knee replacement and found an increased time to receive rescue morphine  compared with placebo (0.8 h) (p < 0.001)  . Additio h . Addip < 0.01). In addition, total opiate consumption was significantly reduced in the IVA group compared with referents. Other studies based in the ICU have focused on delirium in cardiac surgery patients. Reports have estimated that over 50% of patients undergoing major cardiac surgery experience delirium during admission and postoperative pain and excessive opioid consumption potentially lead to this complication (The use of IVA in the ICU setting also has been investigated. A study including patients admitted to the ICU after major abdominal or pelvic surgery examined the amount of opioids used, time to extubation, and opioid-related adverse effects in patients receiving 1 g of IVA every 6 h over 24 h (lication . AlthougThe use of IVA is approved by the Food and Drug Administration for the management of mild to moderate pain, the management of moderate to severe pain with opioid analgesic adjuncts, and fever reduction in adults and children over the age of two . Recent The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


DETECT instrument to screen neuropathic pain in patients with fibromyalgia.Fibromyalgia has a plethorae of symptoms, which can be confusing and even misleading. Accurate evaluation is necessary when patients with fibromyalgia are treated. Different types of instruments are available for the clinicians to supplement evaluation. Our objective was to study the applicability of the PainDETECT, Beck depression inventory IA (BDI IA), Fibromyalgia Impact Questionnaire (FIQ) and a self-made questionnaire regarding present pain and pain relieving methods of the patients. The results of the clinical evaluation and questionnaires were then compared.158 patients with primary fibromyalgia underwent a neurological examination including bedside sensory testing. They also fulfilled four questionnaires: PainDETECT total score (OR: 1.14 95% Cl: 1.06 to 1.22), FM as the worst current pain , body mass index (BMI)  and the intensity of current pain  were significantly associated with the presence of neuropathic pain in univariate analyses.Clinically verified neuropathic pain was diagnosed in 53/158 [34% (95% Cl: 26 to 41)] patients. The ROC curve achieved a maximum Youden´s index at score of 17 when sensitivity was 0.79 (95% Cl: 0.66 to 0.89) and specificity 0.53 (95% Cl: 0.43 to 0.63). The PainDETECT is not as useful in patients with fibromyalgia as in patients with uncompromised central pain control.This study highlights the importance of thorough clinical examination. The Neuropathic pain screening tool Pain Fibromyalgia (FM) is a chronic pain syndrome, which affects up to 5% of the general population . CharactDETECT are recommended for identifying patients with suspected neuropathic pain, particularly when used by non-specialists  patients. Neuropathic pain was definite in 16 (10%) patients, probable in 30 (19%) patients and possible in 7 (4%) patients. The PainThe ROC curve achieved a maximum Youden´s index at score of 17 when sensitivity was 0.79 (95% Cl: 0.66 to 0.89) and specificity 0.53 (95% Cl: 0.43 to 0.63). The area under the curve was 0.69 (95% Cl: 0.60 to 0.77). The predictive value of a positive test and likelihood ratio (positive) were 0.46 (95% Cl: 0.36 to 0.57) and 1.7 (95% Cl: 1.33 to 2.17) respectively , FM as the worst current pain , body mass index (BMI)  and the intensity of current pain  were significantly associated with the presence of neuropathic pain in univariate analyses. The PainDETECT score and the patient’s own assessment of FM pain as their worst pain entered into the forward logistic regression model  may be indicated .It is generally assumed that the bodily distress disorders are highly associated with emotional distress, e.g., mood disorder. However, according to the BDI results, our patients with and without neuropathic pain had similar level of depressive symptoms.The limitations of our study are retrospective setting, cross-sectional clinical evaluation, descriptive nature of the study , secondary health care setting, and ignorance of other pains but FM and neuropathic pain.Diagnosis of neuropathic pain may give an opportunity for curative treatment of the cause of neuropathic pain . In addition, patients with both FM and neuropathic pain might be favorable candidates for a treatment trial with tricyclic antidepressants, pregabalin or duloxetine, which have proved their efficacy for both conditions -27.DETECT are not as useful for FM patients as for other patient. However, if it is used, a positive PainDETECT score still attracts the clinician’s attention to the possibility of neuropathic pain and encourages performing an adequate neurological examination and the consideration of further testing when needed.This study highlights the importance of thorough clinical examination when a FM patient emerges with new symptoms. Neuropathic pain screening tools such as PainThe authors do not have any competing interests in this study.JG, HK and MH conceived of the study and did the statistical analyzes. TH was responsible of clinical examination of participants. JG was responsible of writing the manuscript. PH contributed to study design. HK, PH and MH critically reviewed the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/13/21/prepub


It has been shown that different symptoms or symptom combinations of neuropathic pain (NeP) may correspond to different mechanistic backgrounds and respond differently to treatment. The Neuropathic Pain Symptom Inventory (NPSI) is able to detect distinct clusters of symptoms (i.e. dimensions) with a putative common mechanistic background. The present study described the psychometric validation of the Portuguese version (PV) of the NPSI.Patients were seen in two consecutive visits, three to four weeks apart. They were asked to: (i) rate their mean pain intensity in the last 24 hours on an 11-point (0-10) numerical scale; (ii) complete the PV-NPSI; (iii) provide the list of pain medications and doses currently in use. VAS and Global Impression of Change (GIC) were filled out in the second visit.PV-NPSI underwent test-retest reliability, factor analysis, analysis of sensitivity to changes between both visits. The PV-NPSI was reliable in this setting, with a good intra-class correlation for all items. The factorial analysis showed that the PV-NPSI inventory assessed different components of neuropathic pain. Five different factors were found. The PV-NPSI was adequate to evaluate patients with neuropathic pain and to detect clusters of NeP symptoms.The psychometric properties of the PV-NPSI rendered it adequate to evaluate patients with both central and peripheral neuropathic pain syndromes and to detect clusters of NeP symptoms. Neuropathic pain (NeP) probably concerns 7-8% of the general population ,2. In adNeuropathic pain syndromes are rather heterogeneous and the relationship between a certain etiology and the symptoms reported by patients are not straightforward. Different symptoms  may coexist in the same patient and may reflect different mechanisms of disease . ConsistOnly two questionnaires have been specifically developed to assess the effects of treatment in neuropathic pain syndromes ,15. To dHere we validated the translated Portuguese version of the NPSI (PV-NPSI) . PortuguAfter translation of the NPSI from the original French version and verification of its cultural and conceptual adequacy in Brazilian patients , the psyInclusion criteria were men and women with chronic (> 3 months) neuropathic pain of moderate to severe intensity  of either central or peripheral origin. Neuropathic pain was diagnosed based on the presence of pain with neuropathic characteristics in the topographic distribution of a nervous structure . Lesion Patients were seen in two consecutive visits, three to four weeks apart. In the first visit, before the regular consultation, they were invited to participate in the study protocol and gave their informed consent. Name, age, neuropathic pain diagnosis and associated disorders were recorded, as well as pain symptoms duration. Then they were asked to: (i) rate their mean pain intensity in the last 24 hours on an 11-point (0-10) numerical scale; (ii) complete the PV-NPSI; (iii) provide the list of pain medications and doses currently in use. Pain medication and dosing were quantified according to the Medication Quantification Score (MQS)  and fromi.e: score 4 - no change; on the p-CGC in the second visit).The test-retest reliability of each item and the score of the PV-NPSI was assessed using the Intraclass coefficient (ICC) calculated by the estimation of components by analysis of variance . Long-teAn exploratory factor analysis was performed using the principal component analysis as the method of extraction. The Catell Scree test was used for determining the number of factors extracted. Independent factors were obtained using the Varimax rotation method.Correlations between changes in pain intensity on the 11-point numeric scale and the changes in the PV-NPSI total score and sub scores were evaluated by the Spearman's correlation coefficient.The correlation between the subjective evaluation by patients (p-GIC) in the second visit and the change in the PV-NPSI score and sub scores were assessed by the Spearman's Correlation Coefficient.Ninety-four patients were included in the study. Six failed to come to the second visit within the study interval due to personal reasons. Patient's clinical characteristics and pain etiology are expressed in Table The PV-NPSI was filled out in less than 8 minutes by 85% of the patients. It took less than 12 minutes in the remaining. The "prevalence" (i.e. percentage of patients reporting a score > 0) in the majority of items was 65% (table Thirty patients did not present any change in their pain between both visits (ie. p-GIC). The NPSI scores of these patients were retained to evaluate the test-retest reliability of the PV-NPSI table .The factor analysis identified a five-factor solution, which accounted for 71% of the total variance. Most items had high loadings on only one factor Table .Each of the five factors corresponded to a relevant clinical component of neuropathic pain. Factor 1 included the three items related to evoked pain  and two spontaneous pain items (squeezing and pressure). Factor 2 included two items (i.e. stabbing and pins and needles), which might correspond to the paroxysmal component of spontaneous pain. Factor 3 included tingling . Factor 4 included one item (burning) corresponding to superficial component of ongoing pain frequently observed in neuropathic pain syndromes. Finally, factor 5 included only one item (electric shocks) corresponded to clear paroxysmal pain.nd visits) correlated with the numerical rating scale measured in each visit . However, the change in the PV-NPSI score between both visits (PV-NPSI visit 2 - PV-NPSI visit 1) only weakly correlated with the change in the visual numeric scale between both visits (2nd score - 1st score) (Spearman correlation = 0.22). The change in the PV-NPSI score between both visits did not significantly correlate with pain duration or medication use (MQS).The total score of the questionnaire  with the change in the PV-NPSI score between the two visits (PV-NPSI visit 2 - PV-NPSI visit 1) .The p-GIC and c-GIC scores at the second visit moderately correlated  with the change in the visual numeric scale score between both visits  valid and reliable; (ii) it is sensitive to changes in neuropathic pain of both central and peripheral origin; and (iii) it assessed different aspects of neuropathic pain.The PV-NPSI was filled out in a relatively short period of time making it suitable for the use in clinical practice and in clinical studies. All descriptors were reported in a significant frequency of patients, with a prevalence of 65%. We assessed the test-retest validity of the inventory in those patients who did not present any change in their pain intensity between both visits. The PV-NPSI was reliable in this setting, with a good intraclass correlation for all items.st and 2nd visits correlated with the visual numeric scale score in each of these sessions. However, the change in the PV-NPSI from the 2nd to the 1st visit only weakly correlated to the changes in the VNS score between both instances. This is similar to what was found in the original version of the NPSI [The total score of the PV-NPSI in the 1the NPSI . InteresThe factorial analysis showed that the PV-NPSI assessed different components of neuropathic pain. Five different factors were found. The first factor included evoked pain  and two spontaneous pain descriptors (squeezing and pressure). Two paroxysmal descriptors (stabbing and pins and needles) were clustered in a second factor. The three remaining descriptors were grouped in one factor each . Some of the cluster patterns were slightly different from the original version where spontaneous pain and paroxysmal descriptors were clustered in a single factor each. These differences probably reflect different valences of each descriptor between the two populations .Neuropathic pain is a rather heterogeneous entity and different symptoms may be caused by a single etiological factor, thus suggesting it is a "trans-etiological" entity . NeuropaIn conclusion, the psychometric properties of the PV-NPSI render it adequate to evaluate patients with both central and peripheral neuropathic pain syndromes. The reliability of the different descriptors was adequate and sensitive to change and the NPSI may help select subgroups of NeP patients with different anatomical and mechanistic dysfunctions, and possibly different response to treatment.The authors declare that they have no competing interests.Study Design: DCA, DB, MJT. Data Collection: CMN, AFB, LTY, JA, PRNS, HelenaHK, KS. Data bank feeding: TZ, RG. Statistical analyses: DCA, ETF. Manuscript writing: DCA, KASLF. Manuscript revising: DB, MJT. All authors read and approved the final manuscript.


High-volume infiltration analgesia may be effective in postoperative pain management after hip arthroplasty but methodological problems prevent exact interpretation of previous studies.In a randomized, double-blind placebo-controlled trial in 12 patients undergoing bilateral total hip arthroplasty (THA) in a fast-track setting, saline or high-volume (170 mL) ropivacaine (0.2%) with epinephrine  was administered to the wound intraoperatively along with supplementary postoperative injections via an intraarticular epidural catheter. Oral analgesia was instituted preoperatively with a multimodal regimen . Pain was assessed repeatedly for 48 hours postoperatively, at rest and with 45° hip flexion.Pain scores were low and similar between ropivacaine and saline administration. Median hospital stay was 4 (range 2–7) days.Intraoperative high-volume infiltration with 0.2% ropivacaine with repeated intraarticular injections postoperatively may not give a clinically relevant analgesic effect in THA when combined with a multimodal oral analgesic regimen with gabapentin, celecoxib, and acetaminophen. Continuous epidural analgesia  or contiLocal infiltration analgesia (LIA)  with intThe study was approved by the local ethics committee  and the Danish Data Protection Agency  and was registered with ClinicalTrials.gov under the US National Library of Medicine (Code NCT 00864409). The study was performed in compliance with the Helsinki Declaration.12 consecutive patients scheduled for total bilateral hip arthroplasty (THA) were included from October 2006 through April 2009. The patient characteristics were: 7 men/5 women, mean age 60 (range 41–82) years, mean weight 78 (63–106) kg, mean BMI 26 (23–31), American Society of Anesthesiologists physical status I/II = 7/5. All patients received intraoperative periarticular infiltration with 170 mL 0.2% ropivacaine and epinephrine  in one hip , and simSurgery was performed under spinal anesthesia with 15 mg plain bupivacaine  and propofol was administered (0.5–5 mg/kg/h) for sedation if required. Low-molecular-weight heparin  was administered subcutaneously 6–8 hours postoperatively for thromboprophylaxis and once daily until discharge. A standardized intraoperative regimen for fluid administration was used with 0.9% saline (5 mL/kg/h) and colloid  . BilaterIn one hip, the patients received infiltration with 340 mg ropivacaine (0.2%) with adrenaline (1:100.000) in a total volume of 170 mL. The mixture was injected using a systematic technique to ensure uniform delivery of the local anesthetic to all the tissue that was incised or instrumented during the procedure . The firPostoperatively, the patients were transferred to the post-anesthesia care unit (PACU) and then to a specialized knee and hip arthroplasty unit with a well-defined multimodal fast-track rehabilitation regimen .All patients received orally administered celecoxib , slow-release paracetamol (2 g every 12 hours), gabapentin  for 48 h with intravenous morphine (20 µg/kg), lock-out set to 10 min. Apart from administration of additional sufentanil or morphine in the PACU, the morphine PCA was the only opioid administered in the 48-h study period.8 hours postoperatively, a 20-mL injection of the drug mixture (40 mg ropivacaine and epinephrine (1:100.000)) or 0.9% saline was administered intraarticularly through the catheters in accordance with randomization. 24 h postoperatively, 50 mL of the drug mixture (100 mg ropivacaine with epinephrine (1:100.000)) or 50 mL 0.9% saline was injected.The primary endpoint was postoperative pain in each hip 8 h postoperatively, which was assessed using a visual analog scale (VAS) from 0 to 10 cm, with 0 indicating no pain and 10 indicating the worst possible pain, at rest and upon 45° flexion of the hip with the leg straight. Pain assessment was performed by one of two investigators who were blinded regarding the randomization.Pain was recorded at 4, 8, 9, 24, 24.5, 25, 26, 32, and 48 h after surgery. Throughout the 48-h study period, the amount of morphine delivered via the PCA pump was registered. Length of hospital stay (LOS) was also registered. All the patients were discharged directly to their homes according to functional discharge criteria: ability to get in and out of bed, to get dressed, and to get into and up from a chair; ability to walk independently for 50 m with appropriate walking aids; and acceptance of discharge.The number of participants was set to 12, since no meaningful power calculation could be performed from published data in unilateral hip arthroplasty. Tests for significant differences between treatment groups were done using the Wilcoxon signed ranks test. All p-values < 0.05 were considered statistically significant. All data analysis was done using SPSS for Windows version 12.0.VAS pain scores were similar for the hip infiltrated with ropivacaine and epinephrine and the hip infiltrated with saline (p > 0.05), both at rest and with hip flexion, except for significantly less pain at rest 32 h postoperatively in the hip infiltrated with saline (p = 0.03) .In the PACU, intravenous administration of sufentanil was median 10 (interquartile range 0–30) µg, and median cumulative postoperative PCA morphine administration was 6.5 (4–12) mg, 14 (11–26) mg, 32 (17–53) mg, 36 (19–61) mg, and 43 (20–70) mg at 4, 8, 24, 32, and 48 h postoperatively. Mean duration of surgery was 178 (range 76–325) min. Median hospital stay was 4 days (range 2–7).No clinical side effects, including cardiac and hemodynamic changes requiring intervention, were observed during the study period (intraoperatively and 0–48 h postoperatively).We found that there was acceptable pain relief with multimodal oral analgesia without any clinically relevant analgesic effect of intraoperative high-volume administration of local anesthetic and adrenaline with supplementary postoperative injections to the wound. In spite of the fact that there have been relatively few positive trials published so far  high-volThe choice of postoperative analgesic technique after THA may include continuous or single-dose peripheral nerve blocks or continuous epidural analgesia , high-voAlthough previous THA trials have assessed the value of the high-volume infiltration technique compared to placebo  or epiduAlthough acceptable postoperative pain relief may be achieved with a simple oral analgesic regimen, future improvements in early and late postoperative recovery and rehabilitation should be studied regarding the effect of reduction in the neuroendocrine and inflammatory response in THA, where an elevated C-reactive protein may be a predictor of convalescence after discharge from hospital . FurtherSince the results reported in this study could possibly be the result of a type-2 error  due to the small number of observations, larger-scale trials may be needed to confirm our results. However, the inclusion of patients undergoing bilateral THA increases the strength of our data, and a study of similar design found a substantial analgesic effect of LIA in bilateral knee arthroplasty . FinallyIn conclusion, the results from this randomized, double-blind placebo-controlled trial in bilateral THA showed that there was no clinically relevant analgesic effect of intraoperative high-volume infiltration analgesia with 0.2% ropivacaine combined with repeated postoperative wound injections. Acceptable postoperative pain relief may be achieved with a multimodal oral analgesic regimen with gabapentin, celecoxib, and paracetamol.


Dear Editor,Concerning the article “Comparison of Analgesic Effect between Gabapentin andDiclofenac on Post-Operative Pain in Patients Undergoing Tonsillectomy” published inone of the previous issues of Archives of Trauma Research , I wouldTonsillectomy is an operation that is unpleasant and deeply affects the patient, especiallychildren, for several days after surgery. Although, a variety of different types of drugs havebeen used for pain relief following tonsillectomy, it is still not effectively and fullycontrolled. Gabapentin is mostly used to treat chronic pain, but an increasing number ofrandomized trials demonstrated its efficacy in treating postoperative pain and reducing opioidconsumption . HoweverThis was a carefully performed and well written study. The discussion is very good. However,there are several issues that need to be addressed. First, the results were calculated usingrepeated student’s t-tests for the parametric variables. The question is whether thisis the most appropriate test to compare the three groups and whether it would change theconclusions if the results are analyzed differently? In this regard, it would be advised touse ANOVA or more suitable, to use repeated measures ANOVA. After that, the primary andsecondary outcomes of interest and the time point used are not clear.Lastly, although the authors have focused on the analgesic effect of gabapentin anddiclofenac, it would be important and very engaging to discuss the side effects. Theinteresting aspect of these results is the proportion of patients experiencing vomiting, whichis not remarkable in the present study despite the "emetic nature" of tonsillectomy surgery.Side effects of gabapentin included vomiting, dizziness and headache, but these side effectsare usually seen in long term infusion of gabapentin or high doses of gabapentinadministration. However, a recently published clinical study demonstrated that gabapentin iseffective for reducing the nausea and vomiting induced by chemotherapy  and surgAnd finally, once again I would like to congratulate the authors for such an interesting andcomprehensive study.