RESUMO
OBJECTIVES: We recently reported that percutaneous peripheral nerve stimulation (PNS or "neuromodulation") decreased pain and opioid consumption within the first two weeks following ambulatory surgery. However, the anatomic lead locations were combined for the analysis, and benefits for each location remain unknown. We therefore now report the effects of percutaneous PNS for brachial plexus and sciatic nerve leads separately. MATERIALS AND METHODS: Before surgery, leads were implanted percutaneously to target the brachial plexus (N = 21) for rotator cuff repair or sciatic nerve (N = 40) for foot/ankle surgery, followed by a single injection of local anesthetic. Postoperatively, subjects were randomized in a double masked fashion to 14 days of electrical stimulation (N = 30) or sham/placebo (N = 31) using an external pulse generator. The primary outcome of interest was opioid consumption and pain scores evaluated jointly. Thus, stimulation was deemed effective if superior on either outcome and at least noninferior on the other. RESULTS: For brachial plexus leads, during the first seven postoperative days pain measured with the numeric rating scale in participants given active stimulation was a median [interquartile range] of 0.8 [0.5, 1.6] versus 3.2 [2.7, 3.5] in patients given sham (p < 0.001). For this same group, opioid consumption in participants given active stimulation was 10 mg [5, 20] versus 71 mg [35, 125] in patients given sham (p = 0.043). For sciatic nerve leads, pain scores for the active treatment group were 0.7 [0, 1.4] versus 2.8 [1.6, 4.6] in patients given sham (p < 0.001). During this same period, participants given active stimulation consumed 5 mg [0, 30] of opioids versus 40 mg [20, 105] in patients given sham (p = 0.004). Treatment effects did not differ statistically between the two locations. CONCLUSIONS: Ambulatory percutaneous PNS of both the brachial plexus and sciatic nerve is an effective treatment for acute pain free of systemic side effects following painful orthopedic surgery.
Assuntos
Plexo Braquial , Estimulação Elétrica Nervosa Transcutânea , Humanos , Analgésicos Opioides/uso terapêutico , Projetos Piloto , Dor , Nervo IsquiáticoRESUMO
BACKGROUND: Percutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption. METHODS: Preoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days. RESULTS: During the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001). CONCLUSIONS: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.
Assuntos
Neuroestimuladores Implantáveis , Dor Pós-Operatória/prevenção & controle , Estimulação Elétrica Nervosa Transcutânea/instrumentação , Estimulação Elétrica Nervosa Transcutânea/métodos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/fisiopatologia , Nervos Periféricos/fisiopatologia , Projetos Piloto , Resultado do TratamentoRESUMO
BACKGROUND: Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ambulatory surgery within a real-world clinical practice setting. The primary hypothesis is that surgical pain and opioid consumption during the initial 7 days after surgery will be reduced by percutaneous PNS compared with usual and customary analgesia (dual primary outcome measures). DESIGN: A multicenter pragmatic effectiveness trial. We are randomizing participants having painful orthopedic surgical procedures of the upper and lower extremity to receive 14 days of either 1) electrical stimulation or 2) sham in a double-masked fashion. End points are being assessed at various time points over 12 postoperative months. SUMMARY: The postoperative experience will be much improved if percutaneous PNS provides potent analgesia while concurrently decreasing opioid requirements following painful surgery. Because this modality can be administered for up to 60 days at home, it may provide postoperative analgesia that outlasts surgical pain yet has relatively few risks and, unlike opioids, has no systemic side effects or potential for abuse, addiction, and overdose. Percutaneous PNS has the potential to revolutionize postoperative analgesia as it has been practiced for the past century. This study will inform key stakeholders regarding an evidence-based nonpharmacologic approach to the management of postoperative pain.
Assuntos
Dor Pós-Operatória , Estimulação Elétrica Nervosa Transcutânea , Humanos , Dor Pós-Operatória/terapia , Nervos Periféricos , Ultrassonografia , Ultrassonografia de IntervençãoRESUMO
Orthopedic trauma is a significant military problem, causing several of the most disabling conditions with high rates of separation from duty and erosion of military readiness. The objective of this report is to summarize the findings of case series of a non-opioid therapy-percutaneous peripheral nerve stimulation (PNS) - and describe its potential for postoperative analgesia, early opioid cessation, and improved function following orthopedic trauma. Percutaneous PNS has been evaluated for the treatment of multiple types of pain, including two case series on postoperative pain following total knee replacement (n = 10 and 8, respectively) and a case series on postamputation pain (n = 9). The orthopedic trauma induced during TKR is highly representative of multiple types of orthopedic trauma sustained by Service members and frequently produces intense, prolonged postoperative pain and extended opioid use following surgery. Collectively, the results of these three clinical studies demonstrated that percutaneous PNS can provide substantial pain relief, reduce opioid use, and improve function. These outcomes suggest that there is substantial potential for the use of percutaneous PNS following orthopedic trauma.
Assuntos
Analgésicos Opioides/administração & dosagem , Terapia por Estimulação Elétrica/normas , Manejo da Dor/normas , Dor Pós-Operatória/tratamento farmacológico , Analgésicos/administração & dosagem , Analgésicos/uso terapêutico , Analgésicos Opioides/uso terapêutico , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Terapia por Estimulação Elétrica/métodos , Humanos , Manejo da Dor/métodos , Medição da Dor/métodos , Dor Pós-Operatória/etiologia , Recuperação de Função Fisiológica/efeitos dos fármacosRESUMO
Chronic low back pain represents one of the most common sources of disability and a significant healthcare burden for the U.S. military. Present treatments for chronic back pain are often ineffective, poorly tolerated, invasive, destructive, and/or associated with complications and lead to the progression to invasive surgical procedures. There have been multiple calls for the development of a minimally invasive system that is effective without the risks or complications of existing surgical therapies, which could prevent the need for surgery and the recurrence of pain. The goal of this study was to evaluate a novel, minimally invasive approach using a percutaneous peripheral nerve stimulation (PNS) system designed to provide pain relief without surgery, to reduce complications, and provide a less-invasive treatment option. In nine subjects, percutaneous PNS improved participants' function, as evidenced by clinically and statistically significant reductions in pain, disability, and pain interference. Subjects also experienced reductions in opioid and non-opioid analgesic medication usage and reported improvements in quality of life with treatment. There were no serious or unanticipated adverse events. These results demonstrate the potential of percutaneous PNS as a non-surgical therapy to treat chronic back pain without opioids.
Assuntos
Dor Lombar/terapia , Manejo da Dor/normas , Nervos Periféricos , Estimulação Elétrica Nervosa Transcutânea/normas , Adulto , Dor Crônica/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do TratamentoRESUMO
BACKGROUND: In 2009, the Army Pain Management Task Force was chartered. On the basis of their findings, the Department of Defense recommended a comprehensive pain management strategy that included development of a standardized pain assessment system that would collect patient-reported outcomes data to inform the patient-provider clinical encounter. The result was the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The purpose of this study was to assess the validity and response burden of the patient-reported outcome measures in PASTOR. METHODS: Data for analyses were collected from 681 individuals who completed PASTOR at baseline and follow-up as part of their routine clinical care. The survey tool included self-report measures of pain severity and pain interference (measured using the National Institutes of Health Patient-Reported Outcome Measurement Information System [PROMIS] and the Defense and Veterans Pain Rating scale). PROMIS measures of pain correlates also were administered. Validation analyses included estimation of score associations among measures, comparison of scores of known groups, responsiveness, ceiling and floor effects, and response burden. RESULTS: Results of psychometric testing provided substantial evidence for the validity of PASTOR self-report measures in this population. Expected associations among scores largely supported the concurrent validity of the measures. Scores effectively distinguished among respondents on the basis of their self-reported impressions of general health. PROMIS measures were administered using computer adaptive testing and each, on average, required less than 1 minute to administer. Statistical and graphical analyses demonstrated the responsiveness of PASTOR measures over time.
Assuntos
Medição da Dor/instrumentação , Medição da Dor/normas , Psicometria/normas , Autorrelato , Adulto , Ira , Ansiedade/complicações , Depressão/complicações , Feminino , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Medição da Dor/métodos , Psicometria/instrumentação , Psicometria/métodos , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
Early creation of arteriovenous fistulas (AVFs) decreases morbidity and mortality in patients with end-stage renal disease and is the standard of care in the United States. However, this procedure is frequently not accessible in low- and middle-income countries (LMICs). We present the first reported case of successful AVF creation as part of a humanitarian assistance mission. The patient was a 51-year-old male with diabetes, hypertension, and end-stage renal disease on hemodialysis via a temporary dialysis catheter. Preoperative assessment and patient selection were coordinated with the host nation (HN) nephrologist and dialysis team. The visiting surgical team provided education on AVF anatomy, complications, and cannulation techniques to the HN dialysis team. A left brachiocephalic AVF was created under regional anesthesia performed by the visiting surgeon and anesthesiologists. There were no postoperative complications, and the AVF was matured and accessed successfully by the HN dialysis team 7 weeks after creation. Performing AVFs as part of humanitarian assistance missions has the potential to significantly reduce morbidity and mortality in LMICs.
Assuntos
Derivação Arteriovenosa Cirúrgica , Comportamento Cooperativo , Comunicação Interdisciplinar , Falência Renal Crônica/terapia , Medicina Naval , Equipe de Assistência ao Paciente , Socorro em Desastres , Diálise Renal , Navios , Educação Médica Continuada , Educação Continuada em Enfermagem , Fiji , Humanos , Falência Renal Crônica/diagnóstico , Masculino , Pessoa de Meia-Idade , Nefrologistas/educação , Enfermagem em Nefrologia/educação , Estados UnidosRESUMO
BACKGROUND: Radiofrequency facet denervation is one of the most frequently performed procedures for chronic low back pain. Although sensory stimulation is generally used as a surrogate measure to denote sufficient proximity of the electrode to the nerve, no study has examined whether stimulation threshold influences outcome. METHODS: We prospectively recorded data in 61 consecutive patients undergoing lumbar facet radiofrequency denervation who experienced significant pain relief after medial branch blocks. For each nerve lesioned, multiple attempts were made to maximize sensory stimulation threshold (SST). Mean SST was calculated on the basis of the lowest stimulation perceived at 0.1-V increments for each medial branch. A positive outcome was defined as a ≥50% reduction in back pain coupled with a positive satisfaction score lasting ≥3 months. The relationship between mean SST and denervation outcomes was evaluated via a receiver's operating characteristic (ROC) curve, and stratifying outcomes on the basis of various cutoff values. RESULTS: No correlation was noted between mean SST and pain relief at rest (Pearson's r=-0.01, 95% confidence interval [CI]: -0.24 to 0.23, P=0.97), with activity (r=-0.17, 95% CI: -0.40 to 0.07, P=0.20), or a successful outcome. No optimal SST could be identified. CONCLUSIONS: There is no significant relationship between mean SST during lumbar facet radiofrequency denervation and treatment outcome, which may be due to differences in general sensory perception. Because stimulation threshold was optimized for each patient, these data cannot be interpreted to suggest that sensory testing should not be performed, or that high sensory stimulation thresholds obtained on the first attempt should be deemed acceptable.