Richard Rauck

Carolinas Pain Institute, Winston-Salem, North Carolina, United States

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Publications (131)471.82 Total impact

  • James M. North, Kyung‐soo J. Hong, Richard L. Rauck
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    ABSTRACT: IntroductionWe assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM).Methods Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS).ResultsA total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8.LimitationsSmall sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group.Conclusions Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep.
    Pain Practice 06/2015; DOI:10.1111/papr.12319 · 2.18 Impact Factor
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    ABSTRACT: The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain(CLBP). An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n=134, placebo; n=147, ALO-02). Change in mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P=0.0114). 57.5% of patients treated with ALO-02 and 44.0% of patients treated with placebo reported ≥30% improvement in weekly average NRS-Pain scores from screening to final 2 weeks of the treatment period (P=0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with CLBP and has a safety profile similar to other opioids.
    Pain 05/2015; DOI:10.1097/j.pain.0000000000000230 · 5.84 Impact Factor
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    ABSTRACT: Oral clonidine is used to treat hypertension but often produces sedation and severe dry mouth; intrathecal clonidine is used to treat chronic pain but may produce hypotension. This clinical feasibility study was conducted to determine if intrathecal clonidine decreases blood pressure in patients with poorly controlled hypertension. This prospective, single-arm, open-label study was conducted in ten subjects who were taking at least three antihypertensive medications including a diuretic and had an in-office systolic blood pressure between 140 and 190 mm Hg. On the day of treatment, blood pressure was measured before and after a single lumbar intrathecal dose (150 mcg) of clonidine using an automatic oscillometric device every 10-15 min for four hours. Student's paired t-test was used for statistical comparisons. Maximal reductions in systolic and diastolic blood pressures averaging 63 ± 20/29 ± 13 mm Hg were observed approximately two hours after clonidine administration. Decreases in systolic pressure were strongly correlated with baseline systolic pressure. Clonidine produced a significant decrease in heart rate of 11 ± 7 beats/min. No subject required intravenous fluids or vasopressor rescue therapy, or reported spinal headache. This is the first clinical study in subjects with hypertension that demonstrates significant and profound acute reductions in blood pressure after a single dose of intrathecal clonidine. Future placebo-controlled, dose-escalating studies are warranted to assess the long-term effects of intrathecal clonidine infusion via an implantable drug pump in patients with treatment-resistant hypertension at risk of stroke or myocardial infarction. © 2015 International Neuromodulation Society.
    Neuromodulation 05/2015; DOI:10.1111/ner.12304 · 1.79 Impact Factor
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    ABSTRACT: Interventional spine and pain procedures cover a far broader spectrum than those for regional anesthesia, reflecting diverse targets and goals. When surveyed, interventional pain and spine physicians attending the American Society of Regional Anesthesia and Pain Medicine (ASRA) 11th Annual Pain Medicine Meeting exhorted that existing ASRA guidelines for regional anesthesia in patients on antiplatelet and anticoagulant medications were insufficient for their needs. Those surveyed agreed that procedure-specific and patient-specific factors necessitated separate guidelines for pain and spine procedures.In response, ASRA formed a guidelines committee. After preliminary review of published complication reports and studies, committee members stratified interventional spine and pain procedures according to potential bleeding risk as low-, intermediate-, and high-risk procedures. The ASRA guidelines were deemed largely appropriate for the low- and intermediate-risk categories, but it was agreed that the high-risk targets required an intensive look at issues specific to patient safety and optimal outcomes in pain medicine.The latest evidence was sought through extensive database search strategies and the recommendations were evidence-based when available and pharmacology-driven otherwise. We could not provide strength and grading of these recommendations as there are not enough well-designed large studies concerning interventional pain procedures to support such grading. Although the guidelines could not always be based on randomized studies or on large numbers of patients from pooled databases, it is hoped that they will provide sound recommendations and the evidentiary basis for such recommendations.
    Regional anesthesia and pain medicine 05/2015; 40(3):182-212. DOI:10.1097/AAP.0000000000000223 · 2.12 Impact Factor
  • Richard L Rauck
    Pain Medicine 02/2015; 16(2):404-406. DOI:10.1111/pme.12656 · 2.24 Impact Factor
  • Richard L Rauck, James North, James C Eisenach
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    ABSTRACT: Chronic pain may be accompanied by hyperalgesia and allodynia, and analgesic interventions may reduce these hypersensitivity phenomena. Preclinical data suggest that intrathecal clonidine and adenosine reduce hypersensitivity, but only clonidine reduces pain; therefore, we tested the effects of these interventions in patients with chronic pain. Twenty-two subjects with pain and hyperalgesia in a lower extremity from complex regional pain syndrome were recruited in a double-blind crossover study to receive intrathecal clonidine, 100 μg, or adenosine, 2 mg. Primary outcome measure was proportion with ≥30% reduction in pain 2 hours after injection, and secondary measures were pain report, areas of hypersensitivity, and temporal summation to heat stimuli. Treatments did not differ in the primary outcome measure (10 met success criterion after clonidine administration and 5 after adenosine administration), although they did differ in pain scores over time, with clonidine having a 3-fold greater effect (P = 0.014). Both drugs similarly reduced areas of hyperalgesia and allodynia by approximately 30% and also inhibited temporal summation. The percentage change in pain report did not correlate with the percentage change in areas of hyperalgesia (P = 0.09, r = 0.08) or allodynia (P = 0.24, r = 0.24) after drug treatment. Both intrathecal clonidine and adenosine acutely inhibit experimentally induced and clinical hypersensitivity in patients with chronic regional pain syndrome. Although these drugs do not differ in analgesia by the primary outcome measure, their difference in effect on pain scores over time and lack of correlation between effect on pain and hypersensitivity suggest that analgesia does not parallel antihyperalgesia with these treatments.
    Pain 01/2015; 156(1):88-95. DOI:10.1016/j.pain.0000000000000007 · 5.84 Impact Factor
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    ABSTRACT: IntroductionDiscogenic low back pain (LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty (IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group.Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB.ResultsTwenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported.Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points.
    Pain Medicine 11/2014; 16(3). DOI:10.1111/pme.12595 · 2.24 Impact Factor
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    ABSTRACT: Complex regional pain syndrome (CRPS) is a potentially debilitating chronic pain syndrome with a poorly understood but likely neuroimmune/multifactorial pathophysiology associated with axonal injury. Based on the potential contribution of pro-inflammatory cytokines to CRPS pathogenesis and prior research with thalidomide, we investigated lenalidomide, a thalidomide derivative, for CRPS treatment. We conducted a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral lenalidomide 10 mg once daily in consenting patients with unilateral or bilateral CRPS type 1. The study comprised 12 weeks of treatment followed by a long-term extension. The primary efficacy outcome was reduced pain in the index limb, defined as ≥30% improvement from baseline using an 11-point numerical rating scale. One hundred eighty-four subjects enrolled. The primary endpoint was not met because equal proportions of treated (16.1%) and control (16.1%) subjects achieved the outcome; however, lenalidomide was well tolerated with no evidence of neuropathy or major adverse effects. This study is the largest, controlled, blinded, clinical trial in subjects with chronic CRPS using the Budapest research criteria. It demonstrates the feasibility of conducting high-quality clinical trials in CRPS type 1 and provides considerations for designing future trials. Perspective This article reports an adequately powered, controlled clinical trial in subjects with CRPS. Both treatment and placebo were equally effective, but the study demonstrated that lenalidomide treatment is feasible in this population. The study provides examples to consider in designing future CRPS trials.
    Journal of Pain 10/2014; 15(12). DOI:10.1016/j.jpain.2014.09.013 · 4.22 Impact Factor
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    ABSTRACT: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.
    Neuromodulation 08/2014; 17(6):515-550. DOI:10.1111/ner.12208 · 1.79 Impact Factor
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    ABSTRACT: To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain (BTCP) and the dose of around-the-clock (ATC) opioid used to control background pain.
    Journal of opioid management 07/2014; 10(4):241-248. DOI:10.5055/jom.2014.0212
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    ABSTRACT: Objectives Breakthrough cancer pain (BTCP) is associated with decreased satisfaction with around-the-clock opioid therapy. This analysis examined patient satisfaction with fentanyl sublingual spray for BTCP during the open-label titration period of a randomized, placebo-controlled study.Methods Opioid-tolerant patients with 1 to 4 daily BTCP episodes were included. During a 26-day, open-label titration phase, a successful dose (100 to 1600 mcg) of fentanyl sublingual spray was established that provided effective analgesia for 2 consecutive BTCP episodes with tolerable side effects. The Treatment Satisfaction Questionnaire for Medication (TSQM) was administered at baseline to assess satisfaction with previous BTCP medication and at the end of the titration to assess satisfaction with fentanyl sublingual spray.ResultsOf 130 enrolled patients, 115 (88.5%) had a TSQM measure at baseline and at the end of their titration period. Scores on all 4 TSQM domains increased from baseline to end of the titration, with mean (standard error [SE]) improvements of 22.3 (2.3) for effectiveness, 7.7 (3.2) for side effects, 6.8 (2.2) for convenience, and 12.9 (2.8) for global satisfaction (P < 0.05 for all). Satisfaction with symptom relief (26.1% to 77.4%) and onset of action (21.7% to 82.6%) also improved from baseline to end of titration. At least one adverse event (AE) was reported by 78 patients (60.0%). The most common AEs considered possibly or probably related to study medication were dizziness, somnolence, and nausea (n = 10 [7.7%] each).DiscussionThese data indicate markedly improved satisfaction among patients receiving fentanyl sublingual spray relative to previous BTCP medications.
    Pain Practice 07/2014; DOI:10.1111/papr.12225 · 2.18 Impact Factor
  • Journal of Pain 04/2014; 15(4):S72. DOI:10.1016/j.jpain.2014.01.296 · 4.22 Impact Factor
  • Journal of Pain 04/2014; 15(4):S78. DOI:10.1016/j.jpain.2014.01.321 · 4.22 Impact Factor
  • Journal of Pain 04/2014; 15(4):S67. DOI:10.1016/j.jpain.2014.01.277 · 4.22 Impact Factor
  • Journal of Pain 04/2014; 15(4):S67. DOI:10.1016/j.jpain.2014.01.276 · 4.22 Impact Factor
  • Journal of Pain 04/2014; 15(4):S74. DOI:10.1016/j.jpain.2014.01.304 · 4.22 Impact Factor
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    ABSTRACT: A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20-100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction (Subject Global Assessment of Medication) were assessed. Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP.
    Pain Medicine 02/2014; 15(6). DOI:10.1111/pme.12377 · 2.24 Impact Factor
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    ABSTRACT: The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.
    Neuromodulation 01/2014; 17(4). DOI:10.1111/ner.12146 · 1.79 Impact Factor
  • Leonardo Kapural, Richard L Rauck
    The Clinical journal of pain 01/2014; 30(1):92. DOI:10.1097/AJP.0b013e318292df88 · 2.70 Impact Factor
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    ABSTRACT: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. This multicenter, open-label study started with a conversion/titration phase (≤6 weeks) where subjects (n=638) were converted to individualized doses (range 20-300 mg) of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424). The primary objective (safety and tolerability) and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain) were monitored throughout the study. Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%), nausea (10.7% and 9.9%), vomiting (4.1% and 9.7%), and somnolence (7.7% and 4.2%). Four deaths occurred during the study; all were considered unrelated to treatment. One subject died 13 months after the study ended. From the start to end of the conversion/titration phase, 84% of subjects had a clinically meaningful improvement in average pain score (≥30% improvement), and the mean average pain scores remained stable through the maintenance phase. This single-entity, extended-release formulation of hydrocodone was generally safe, well tolerated, and effective in reducing chronic pain for 48 weeks. This formulation provides a new option for patients experiencing chronic pain, especially those who are taking immediate-release hydrocodone and have concerns about liver toxicity due to acetaminophen.
    Journal of Pain Research 01/2014; 7:669-678. DOI:10.2147/JPR.S71536

Publication Stats

3k Citations
471.82 Total Impact Points

Institutions

  • 2006–2015
    • Carolinas Pain Institute
      • Center for Clinical Research
      Winston-Salem, North Carolina, United States
  • 2008–2014
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • Winston-Salem State University
      Winston-Salem, North Carolina, United States
  • 2012
    • Johns Hopkins University
      • Department of Anesthesiology and Critical Care Medicine
      Baltimore, Maryland, United States
    • Jefferson College
      Хиллсборо, Missouri, United States
  • 1990–2012
    • Wake Forest University
      • Department of Anesthesiology
      Winston-Salem, North Carolina, United States
  • 2011
    • The University of Arizona
      Tucson, Arizona, United States
  • 2005
    • Virginia Commonwealth University
      Richmond, Virginia, United States
  • 2003
    • Wake Forest School of Medicine
      • Department of Anesthesiology
      Winston-Salem, North Carolina, United States