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Intrathecal Drug Delivery

Zhicheng Wang, Jia Nong, Robert B Shultz, Zhiling Zhang, Veronica J Tom, Ravi K Ponnappan, Yinghui Zhong
Many mechanisms contribute to the secondary injury cascades following traumatic spinal cord injury (SCI). However, most current treatment strategies only target one or a few elements in the injury cascades, and have been largely unsuccessful in clinical trials. Minocycline hydrochloride (MH) is a clinically available antibiotic and anti-inflammatory drug that has been shown to target a broad range of secondary injury mechanisms via its anti-inflammatory, anti-oxidant, and anti-apoptotic properties. However, MH is only neuroprotective at high concentrations...
October 5, 2016: Biomaterials
Peter E Konrad, John M Huffman, Lisa M Stearns, Robert J Plunkett, Eric J Grigsby, E K Stromberg, Mollie P Roediger, Michelle D Wells, Todd W Weaver
OBJECTIVES: The ISPR was initially created to monitor the product performance of Medtronic implanted intrathecal drug infusion and spinal cord systems available in the United States. MATERIALS AND METHODS: Data were collected from 50 representative sites implanting and following patients with intrathecal drug delivery systems across the United States between August 7, 2003 and January 31, 2014. Device performance over time was estimated using life table survival methods...
October 12, 2016: Neuromodulation: Journal of the International Neuromodulation Society
J S Berger, A Gonzalez, A Hopkins, T Alshaeri, D Jeon, S Wang, R L Amdur, R Smiley
BACKGROUND: The appropriate dose of intrathecal morphine for post-cesarean analgesia is unclear. With the inclusion of routine non-steroidal anti-inflammatory drugs, the required dose of morphine may be significantly less than the 200-300μg common a decade ago. We performed a two-center, prospective, randomized, blinded trial comparing three doses of intrathecal morphine, combined with routine intravenous ketorolac, in 144 healthy women undergoing elective cesarean delivery. METHODS: Patients received an intrathecal injection of hyperbaric bupivacaine 12mg, fentanyl 15μg and a randomized dose of 50, 100, or 150μg morphine in a volume of 2...
August 28, 2016: International Journal of Obstetric Anesthesia
Daniel A Wolf, Jacob Y Hesterman, Jenna M Sullivan, Kelly D Orcutt, Matthew D Silva, Merryl Lobo, Tyler Wellman, Jack Hoppin, Ajay Verma
The intrathecal (IT) dosing route offers a seemingly obvious solution for delivering drugs directly to the central nervous system. However, gaps in understanding drug molecule behavior within the anatomically and kinetically unique environment of the mammalian IT space have impeded the establishment of pharmacokinetic principles for optimizing regional drug exposure along the neuraxis. Here, we have utilized high-resolution single-photon emission tomography with X-ray computed tomography to study the behavior of multiple molecular imaging tracers following an IT bolus injection, with supporting histology, autoradiography, block-face tomography, and MRI...
February 25, 2016: JCI Insight
Sam Eldabe, Rui V Duarte, Grace Madzinga, Alan M Batterham, Morag E Brookes, Ashish P Gulve, Christophe Perruchoud, Jon H Raphael, David Lorenzana, Eric Buchser
OBJECTIVE:  Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion. METHODS:  Eligible patients implanted with a programmable ITDD device were randomized to receive two weeks of either intermittent boluses or a simple continuous flow in period 1, followed by a crossover to the alternative mode of administration...
September 19, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
J C Tien, M J Lim, W L Leong, E Lew
BACKGROUND: The KK Women's and Children's Hospital is a tertiary obstetric unit with approximately 11000 deliveries per year. Epidural analgesia is used in about 40% of laboring women. We reviewed the incidence and management of post-dural puncture headache over a nine-year period. METHODS: A retrospective audit of labor epidural analgesia database records from 1 June 2005 to 31 May 2014 was conducted, identifying an "event" as an accidental dural puncture, an inadvertent intrathecal catheter insertion and/or development of a post-dural puncture headache...
June 30, 2016: International Journal of Obstetric Anesthesia
Anne Paavola, Christopher M Bernards, Per H Rosenberg
In order to avoid the risks of side-effects of epidural local anesthetics and opioids, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) epidurally would be an interesting option of analgesic therapy. The fairly short duration of action of spinally administered NSAIDs, e.g., ibuprofen, may be prolonged by using controlled release poloxamer gel formulation. Using a microdialysis technique we studied the epidural and intrathecal pharmacokinetics of ibuprofen after its epidural administration as a poloxamer 407 formulation or a solution formulation...
September 8, 2016: European Journal of Pharmaceutics and Biopharmaceutics
Markus A Bendel, Susan M Moeschler, Wenchun Qu, Eugerie Hanley, Stephanie A Neuman, Jason S Eldrige, Bryan C Hoelzer
A recent publication reported the incidence of postdural puncture headache (PDPH) in conjunction with intrathecal drug delivery system (IDDS) implantation to be nearly 23 percent. Many patients responded to conservative measures but a percentage needed invasive treatment with an epidural blood patch (EBP). There is limited data to describe the technical details, success rates, and complications associated with EBP in this population. This study aims to provide a retrospective report of EBP for patients suffering from PDPH related to IDDS implantation...
2016: Pain Research and Treatment
Emily Wersocki, John Bedson, Ying Chen, Linda LeResche, Kate M Dunn
A comprehensive systematic literature review of reproductive side effects in women 18-55 years old treated with opioids for one month or longer for chronic non cancer pain. A search of seven databases including EMBASE and Medline was undertaken (October 2014 and a limited re-run April 2016). The search contained key words for opioids (generic and specific drug names) and side effects (generic and specific reproductive). Titles were screened using predefined criteria by a single reviewer and abstracts and full texts by two independent reviewers...
August 19, 2016: Pain
Rui Duarte, Jon Raphael, Sam Eldabe
This article provides a summary of the updated British Pain Society Guidance on Intrathecal Drug Delivery for the management of pain and spasticity in adults. We aim to highlight the areas of the guidance that have been updated and to provide a concise summary.
May 2016: British Journal of Pain
Maura M Scanlon, Halena M Gazelka, Susan M Moeschler, Bryan C Hoelzer, W Michael Hooten, Markus A Bendel, Tim J Lamer
OBJECTIVES:  Our purpose was to determine the incidence of surgical site infection (SSI) in cancer patients receiving an intrathecal drug delivery system (IDDS) and compare that rate with the incidence of SSI in the general population receiving an IDDS or spinal cord stimulator. We attempted to describe risk factors for SSIs in cancer patients treated with IDDS in terms of exposure to cancer treatments. DESIGN:  Retrospective review. SETTING:  Large tertiary care center...
August 22, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Joakim Bergman, Ann Dring, Henrik Zetterberg, Kaj Blennow, Niklas Norgren, Jonathan Gilthorpe, Tommy Bergenheim, Anders Svenningsson
OBJECTIVE: In an ongoing, open-label, phase 1b study on the intrathecal administration of rituximab for progressive multiple sclerosis, an intraventricular catheter was inserted for drug delivery. The objective of this study was to characterize the limited white matter axonal injury evoked by catheter insertion by analyzing a panel of markers for tissue damage in CSF and serum. METHODS: Lumbar CSF and serum were collected before catheter insertion and at regular intervals during the follow-up period of 1 year...
October 2016: Neurology® Neuroimmunology & Neuroinflammation
I Elias Veizi, Salim M Hayek, Michael Hanes, Ryan Galica, Sivakanth Katta, Tony Yaksh
BACKGROUND: Intrathecal drug delivery therapy has been used effectively in treating patients with intractable chronic pain. The development of an intrathecal catheter tip granuloma (ICTG) related to delivery of intrathecal opiates is a relatively infrequent, but potentially devastating complication. While there are many morphine-related ICTG cases described, reports of hydromorphone-related ICTG are limited. In addition, studies suggest a strong correlation between the use of higher doses and concentrations of intrathecal opiates and ICTG formation...
October 2016: Neuromodulation: Journal of the International Neuromodulation Society
Michael F Saulino, Teresa Patel, Stanley P Fisher
OBJECTIVE: This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. METHODS: The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy...
August 1, 2016: Neuromodulation: Journal of the International Neuromodulation Society
Aaron L Boster, Susan E Bennett, Gerald S Bilsky, Mark Gudesblatt, Stephen F Koelbel, Maura McManus, Michael Saulino
INTRODUCTION: Intrathecal baclofen (ITB) screening assesses response to a test dose of ITB on spasticity and function and identifies adverse reactions. METHOD: An expert panel consulted on best practices after conducting an extensive literature search and conducting an online survey. RESULTS: A successful trial may confirm predetermined goals, which may include improved mobility/positioning, decreased time/improved independence for activities, less home exercise, better wheelchair tolerance, decreased caregiver time, improved sleep, and reduced pain, or may modify goals and expectations...
August 2016: Neuromodulation: Journal of the International Neuromodulation Society
Aaron L Boster, Roy L Adair, Judith L Gooch, Mary Elizabeth S Nelson, Andrea Toomer, Joe Urquidez, Michael Saulino
INTRODUCTION: Intrathecal baclofen (ITB) therapy aims to reduce spasticity and provide functional control. METHOD: An expert panel consulted on best practices. RESULTS: Pump fill and drug delivery can be started intraoperatively, with monitoring for at least eight hours. Initiate with the 500 mcg/mL concentration. The starting daily dose should be twice the effective bolus screening dose, or the screening dose if the patient had a prolonged response (greater than eight hours) or negative reactions...
August 2016: Neuromodulation: Journal of the International Neuromodulation Society
Rui V Duarte, Tosin Lambe, Jon H Raphael, Sam Eldabe, Lazaros Andronis
INTRODUCTION: Intrathecal drug delivery (ITDD) systems are an option for the management of patients with chronic non-cancer pain, cancer pain and spasticity. Concerns over their invasiveness and high initial costs have led National Health Service (NHS) England to decommission ITDD for patients with chronic non-cancer pain. However, the extent to which this decision is in line with existing economic evidence is unclear. To address this question, we will carry out a systematic review to identify and evaluate the existing evidence on the cost-effectiveness of ITDD for chronic non-cancer pain...
2016: BMJ Open
Matthias Morgalla, Marcos Fortunato, Ala Azam, Marcos Tatagiba, Guillherme Lepski
BACKGROUND: The assessment of the functionality of intrathecal drug delivery (IDD) systems remains difficult and time-consuming. Catheter-related problems are still very common, and sometimes difficult to diagnose. OBJECTIVES: The aim of the present study is to investigate the accuracy of high-resolution three-dimensional computed tomography (CT) in order to detect catheter-related pump dysfunction. STUDY DESIGN: An observational, retrospective investigation...
July 2016: Pain Physician
Sanjeet Narang, Suresh K Srinivasan, Nantthasorn Zinboonyahgoon, Christian E Sampson
INTRODUCTION: Neuraxial drug delivery via intrathecal drug delivery systems (IDDS) is becoming an increasingly common mode of treating intractable cancer-related pain, chronic pain, or severe spasticity. An implanted infusion pump delivers medication into the intrathecal (subarachnoid) space via a thin catheter. These pumps are commonly placed in the anterior abdominal wall. Certain conditions may render it difficult or unsafe for an IDDS to be implanted at the traditional site; thus, alternative sites have been explored...
August 2016: Neuromodulation: Journal of the International Neuromodulation Society
Brian R Vuillemenot, Sven Korte, Teresa L Wright, Eric L Adams, Robert B Boyd, Mark T Butt
Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle...
July 2016: Toxicological Sciences: An Official Journal of the Society of Toxicology
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