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Denis Dupoiron - One of the best experts on this subject based on the ideXlab platform.
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Multimodal Intrathecal therapy for phantom limb pain: a report of 2 cases
Colombian Journal of Anesthesiology, 2019Co-Authors: Gabriel Carvajal, Andrés Rocha, Denis DupoironAbstract:Introduction: Phantom limb pain (PLP) is a chronic debilitating condition, frequently observed in amputees. At present, there is no standard treatment, and its optimal management requires a multidisciplinary approach in which minimally invasive treatment should be considered in more complex cases. Objective: To report successful treatment of 2 cases of PLP treated with ziconotide as part of multimodal Intrathecal management. Materials and methods: Descriptive, retrospective case report developed in a multimodal pain treatment unit. Results: A total of 2 cases of patients with diagnosis of PLP refractory to medical therapy, treated with Intrathecal multimodal therapy, are presented. Their favorable course, with 50% pain reduction, is described. Conclusion: Implantation of infusion systems for administration of Intrathecal Analgesia with ziconotide at the cervical and supraspinal level proved to be effective in the described cases; this technique should be evaluated in specific trials for the treatment of PLP refractory to other therapies.
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Stability of sufentanil and baclofen mixtures for Intrathecal Analgesia at different concentrations in polypropylene syringes.
Annales pharmaceutiques francaises, 2018Co-Authors: Jérémy Sorrieul, Julien Robert, Vincent Gibory, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Catherine DevysAbstract:Summary Background Intrathecal Analgesia is a method using various molecules alone or in combination. Among these, the association sufentanil/ baclofen is widely used. Instead of moving patients to the few expert centers taking charge of these specific preparations, it could be better to transport syringes to peripheral centers managing pump refilling. That is why, it is interesting to demonstrate the stability of the mixture, and so to be able to ensure the best transport conditions of syringes. Methods A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Four mixtures of sufentanil baclofen stored in 5 ± 3 °C and 25 ± 2 °C were evaluated for seven days and compared to the initial observed concentrations. Results The stability is demonstrated only for preparations stored at 5 ± 3 °C for seven days thanks to relative concentrations (95% confidence intervals of the mean of 3 samples) systematically positioned between 90% and 110%. On the other hand, after few days, degradation products of sufentanil appeared for all mixtures stored at 25 °C ± 2 °C. Conclusion This study shows the stability of a weakly and a highly concentrated mixture of sufentanil and baclofen solutions in polypropylene syringes stored at 5 ± 3 °C for seven days. This result will allow the transport of the preparation under optimal conditions. Advance preparations for Intrathecal pump refills could also be feasible.
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Validated chromatographic method for the simultaneous determination of eight drugs (morphine, ropivacaine, bupivacaine, baclofen, clonidine, sufentanil, fentanyl and ziconotide) for Intrathecal Analgesia.
Annales pharmaceutiques francaises, 2018Co-Authors: Jérémy Sorrieul, Julien Robert, Vincent Gibory, M. Collet, M. Boutet, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Catherine DevysAbstract:Intrathecal Analgesia has increased over the past two decades in various indications: chronic refractory pain from cancerous or non-cancerous origins, spasticity. These different indications involve the use of different molecules alone or in combination such as morphine, ropivacaine, bupivacaine, fentanyl, sufentanil, clonidine, baclofen and ziconotide. Pump refills are prepared at the pharmacy under a laminar flow hood. An analytical control should be carried out before release of the preparation. A new method of analytical control by chromatography has been developed and validated according to the International Conference on Harmonization guideline in order to secure the production process.
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Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia
International journal of pharmaceutical compounding, 2017Co-Authors: Julien Robert, Jérémy Sorrieul, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Elsa Rossignol, Hélène Beaussart, Catherine DevysAbstract:Pain is the most feared symptom amongst individuals living with cancer. In 15% to 20% of patients, conventional analgesic therapy either fails to relieve pain or induces adverse effects. Intrathecal drug delivery systems may present an effective alternative for pain management. The Cancerology Center Paul Papin protocol includes an admixture of morphine, ropivacaine, and ziconotide in Intrathecal preparations. These drugs are administered by a fully implantable or an external pump. Syringes or polyolefin infusion bags are prepared for refill just before use. Few centers in France use the method of Intrathecal Analgesia. Therefore, for those patients receiving Intrathecal preparations, each filling requires that the patients be transported from their local hospital (or their home) to a referral center where the patients are monitored. They sometimes must travel up to a hundred kilometers to have a pump filled. The preparation and the analytical control of the mixture are carried out only by those centers meeting the proper criteria, which includes the proper equipment. To spare the patient this travel, a peripheral center may be subcontracted to manage the patient's pump refill. No data are available concerning the chemical stability of admixtures in syringes or polyolefin infusion bags. The aim of this study was to evaluate, with a new analytical method using ultra high-performance liquid chromatography, the chemical stability of these admixtures in syringes or in polyolefin infusion bags. Ziconotide 1 µg/mL was combined with ropivacaine (7.5 mg/mL) and morphine (3.5 mg/mL) in syringes at 5°C, 21°C, and 31°C, and in polyolefin infusion bags at 21°C. Assays were performed using ultra high-pressure liquid chromatography. In syringes stored at 21°C and 31°C, concentrations after 6 hours were not in the acceptable criterion of 10% variability. When syringes were stored at 5°C, the residual concentration of ziconotide after 3 days was 100.5% +/- 2.6% [92.7% to 108.4%]. In polyolefin infusion bags, the residual concentration of ziconotide after 14 days was 96.9% +/- 2.2% [90.1% to 103.6%]. This study demonstrates the chemical stability of this admixture in syringes stored at 5°C for 3 days and in polyolefin plastibags stored at 21°C for 14 days.
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Simultaneous Determination of Sufentanil and Ziconotide in Combination for Intrathecal Analgesia by UPLC-UV
Pharmaceutical Technology in Hospital Pharmacy, 2016Co-Authors: Jérémy Sorrieul, Vincent Gibory, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Chau Phi Dinh, Catherine DevysAbstract:AbstractIntrathecal Analgesia has increased over the past two decades based on high level proof of efficacy in patients with cancer. Morphine and Ziconotide remains the reference. Polyanalgesic Consensus Conference IT treatment algorithm recommends as the second line therapy opioids/ziconotide combination. Sufentanil and ziconotide combination can be used. The implantable pumps development helped to improve the comfort of the patient. The refills were prepared under a laminar airflow hood under strictly aseptic conditions, by the hospital pharmacist. In order to secure the process, a new analytical method by simple liquid chromatography ultraviolet spectrometry method was developed for the simultaneous quantification of two analgesic drugs (sufentanil, ziconotide). The method was validated according to the recommendation of the US Food and Drug Administration (FDA). The method was linear between 0.1 to 4 μg/mL for ziconotide and 3.125 to 50 µg/mL for sufentanil. This routine quality control analysis secures the production process.
Denise Wilkes - One of the best experts on this subject based on the ideXlab platform.
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Intrathecal Catheter-Syringe Adaptor for Short-Term Intrathecal Analgesia with an Externalized Pump: A Case Report
Pain Physician, 2010Co-Authors: Denise WilkesAbstract:Background: In most patients, cancer pain is effectively treated with conservative medical management consisting of oral and/or transdermal analgesics. Cancer patients tend to fail conservative medical management near the end of their life expectancy, thus requiring alternative routes of Analgesia such as intravenous, epidural, or Intrathecal. The Intrathecal route provides the most effective Analgesia due to the close proximity of the opioid receptors in the spinal cord. Though there are many techniques that exist for Intrathecal drug delivery, complications can limit effectiveness such as infection, bleeding, cerebrospinal fluid (CSF) leaks, post-dural puncture headaches (PDPH), pump and/or catheter malfunctions, or limitations of technical expertise. Therefore, an important goal in palliative cancer pain therapy is to use equipment that is going to have the fewest number of complications and will be the most familiar to the health care providers. We describe the combination of the Medtronic Indura 1P catheter, which has the least catheter-related complications and can be used with any external drug infusion pump. These are regular infusion pumps that the health care workers are familiar with so they can provide excellent and efficient service to the patient. Methods: In an operating room, the Intrathecal catheter was placed using sterile technique under fluoroscopic guidance. The epidural space was identified with loss of resistance technique. Then the introducer needle (supplied in the Indura 1P catheter kit) was advanced until free-flowing CSF was obtained. The spinal catheter was advanced into the Intrathecal space through the introducer needle to lumbar 2-3 level. The catheter was tunneled subcutaneously 10 cm lateral to the catheter exit site. A syringe filling device was inserted into the catheter opening and was secured with silk suture. A luer lock syringe was attached to the syringe filling device and CSF was aspirated. The syringe filling device was capped and later attached to an external drug infusion pump. Results: We report the successful use of the Medtronic Indura 1P, one piece Intrathecal catheter, connected to the external drug pump for a 3 week period in a patient with metastatic cervical cancer for palliative pain control. Limitations: Case report only. Conclusion: This technique is simple to perform by pain specialists. The catheter modification allows the use of the Medtronic Intrathecal catheter with standard external drug infusion pumps. This facilitates the patient’s care in the hospice setting. Key words: Intrathecal drug delivery, palliative medicine, Intrathecal Analgesia, Intrathecal catheter complications, cancer pain, end of life pain control
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Intrathecal catheter-syringe adaptor for short-term Intrathecal Analgesia with an externalized pump: a case report.
Pain physician, 2010Co-Authors: Denise Wilkes, Michael Cook, Daneshvari R. SolankiAbstract:Background In most patients, cancer pain is effectively treated with conservative medical management consisting of oral and/or transdermal analgesics. Cancer patients tend to fail conservative medical management near the end of their life expectancy, thus requiring alternative routes of Analgesia such as intravenous, epidural, or Intrathecal. The Intrathecal route provides the most effective Analgesia due to the close proximity of the opioid receptors in the spinal cord. Though there are many techniques that exist for Intrathecal drug delivery, complications can limit effectiveness such as infection, bleeding, cerebrospinal fluid (CSF) leaks, post-dural puncture headaches (PDPH), pump and/or catheter malfunctions, or limitations of technical expertise. Therefore, an important goal in palliative cancer pain therapy is to use equipment that is going to have the fewest number of complications and will be the most familiar to the health care providers. We describe the combination of the Medtronic Indura 1P catheter, which has the least catheter-related complications and can be used with any external drug infusion pump. These are regular infusion pumps that the health care workers are familiar with so they can provide excellent and efficient service to the patient. Methods In an operating room, the Intrathecal catheter was placed using sterile technique under fluoroscopic guidance. The epidural space was identified with loss of resistance technique. Then the introducer needle (supplied in the Indura 1P catheter kit) was advanced until free-flowing CSF was obtained. The spinal catheter was advanced into the Intrathecal space through the introducer needle to lumbar 2-3 level. The catheter was tunneled subcutaneously 10 cm lateral to the catheter exit site. A syringe filling device was inserted into the catheter opening and was secured with silk suture. A luer lock syringe was attached to the syringe filling device and CSF was aspirated. The syringe filling device was capped and later attached to an external drug infusion pump. Results We report the successful use of the Medtronic Indura 1P, one piece Intrathecal catheter, connected to the external drug pump for a 3 week period in a patient with metastatic cervical cancer for palliative pain control. Limitations Case report only. Conclusion This technique is simple to perform by pain specialists. The catheter modification allows the use of the Medtronic Intrathecal catheter with standard external drug infusion pumps. This facilitates the patient's care in the hospice setting.
Catherine Devys - One of the best experts on this subject based on the ideXlab platform.
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Physicochemical Stability of Ternary Mixtures of Sufentanil, Baclofen, and Ropivacaine in Polypropylene Syringes for Intrathecal Analgesia.
International journal of pharmaceutical compounding, 2020Co-Authors: Jérémy Sorrieul, Julien Robert, Fanny Chapel, Thomas Gossye, Catherine DevysAbstract:Intrathecal Analgesia is a method using various molecules alone or in combination. Among these, a preparation of sufentanil-ropivacaine-baclofen is widely used. Instead of moving patients to the few expert centers taking charge of these specific preparations, it could be beneficial to transport syringes to peripheral centers who manage pump refills. The objective of this study was to determine the physicochemical compatibility and stability of a preparation of sufentanil, ropivacaine, and baclofen in polypropylene syringes. Drugs were mixed together at different concentrations and stored with light protection at 5°C ± 3°C and 25°C ± 2°C. The stabilities were determined by visual inspection, turbidity, pH measurement, and ultra-high-pressure liquid chromatography assay of drug concentrations. The concentrations of ropivacaine, baclofen, and sufentanil were stable after 7 days at 5°C ± 3°C and no degradation of product appeared. The drug mixtures were clear in appearance and no color change or precipitation was observed. Throughout this period, the absorbance and the pH value of samples remained stable. The preparations of sufentanil, baclofen, and ropivacaine remained stable for at least 7 days when stored in polypropylene syringes at 5°C ± 3°C.
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Feedback on the Centralization of Intrathecal Analgesic Preparations in Hospital Pharmacy
Pharmaceutical Technology in Hospital Pharmacy, 2018Co-Authors: Jérémy Sorrieul, Julien Robert, Hélène Kieffer, Caroline Folliard, Catherine DevysAbstract:Abstract Intrathecal Analgesia has increased over the last 30 years. In oncology, it is a real alternative for the treatment of refractory pain. The diversity of the molecules alone or in combination that can be used, the risk related to the route of administration, and the cost of certain molecules are all arguments in favor of centralized preparation within the pharmacy. The purposes of this work are first of all to explain the reasons for centralization of these preparations, and in a second time to describe the circuit developed within our establishment.
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Stability of sufentanil and baclofen mixtures for Intrathecal Analgesia at different concentrations in polypropylene syringes.
Annales pharmaceutiques francaises, 2018Co-Authors: Jérémy Sorrieul, Julien Robert, Vincent Gibory, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Catherine DevysAbstract:Summary Background Intrathecal Analgesia is a method using various molecules alone or in combination. Among these, the association sufentanil/ baclofen is widely used. Instead of moving patients to the few expert centers taking charge of these specific preparations, it could be better to transport syringes to peripheral centers managing pump refilling. That is why, it is interesting to demonstrate the stability of the mixture, and so to be able to ensure the best transport conditions of syringes. Methods A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Four mixtures of sufentanil baclofen stored in 5 ± 3 °C and 25 ± 2 °C were evaluated for seven days and compared to the initial observed concentrations. Results The stability is demonstrated only for preparations stored at 5 ± 3 °C for seven days thanks to relative concentrations (95% confidence intervals of the mean of 3 samples) systematically positioned between 90% and 110%. On the other hand, after few days, degradation products of sufentanil appeared for all mixtures stored at 25 °C ± 2 °C. Conclusion This study shows the stability of a weakly and a highly concentrated mixture of sufentanil and baclofen solutions in polypropylene syringes stored at 5 ± 3 °C for seven days. This result will allow the transport of the preparation under optimal conditions. Advance preparations for Intrathecal pump refills could also be feasible.
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Validated chromatographic method for the simultaneous determination of eight drugs (morphine, ropivacaine, bupivacaine, baclofen, clonidine, sufentanil, fentanyl and ziconotide) for Intrathecal Analgesia.
Annales pharmaceutiques francaises, 2018Co-Authors: Jérémy Sorrieul, Julien Robert, Vincent Gibory, M. Collet, M. Boutet, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Catherine DevysAbstract:Intrathecal Analgesia has increased over the past two decades in various indications: chronic refractory pain from cancerous or non-cancerous origins, spasticity. These different indications involve the use of different molecules alone or in combination such as morphine, ropivacaine, bupivacaine, fentanyl, sufentanil, clonidine, baclofen and ziconotide. Pump refills are prepared at the pharmacy under a laminar flow hood. An analytical control should be carried out before release of the preparation. A new method of analytical control by chromatography has been developed and validated according to the International Conference on Harmonization guideline in order to secure the production process.
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Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia
International journal of pharmaceutical compounding, 2017Co-Authors: Julien Robert, Jérémy Sorrieul, Hélène Kieffer, Caroline Folliard, Denis Dupoiron, Elsa Rossignol, Hélène Beaussart, Catherine DevysAbstract:Pain is the most feared symptom amongst individuals living with cancer. In 15% to 20% of patients, conventional analgesic therapy either fails to relieve pain or induces adverse effects. Intrathecal drug delivery systems may present an effective alternative for pain management. The Cancerology Center Paul Papin protocol includes an admixture of morphine, ropivacaine, and ziconotide in Intrathecal preparations. These drugs are administered by a fully implantable or an external pump. Syringes or polyolefin infusion bags are prepared for refill just before use. Few centers in France use the method of Intrathecal Analgesia. Therefore, for those patients receiving Intrathecal preparations, each filling requires that the patients be transported from their local hospital (or their home) to a referral center where the patients are monitored. They sometimes must travel up to a hundred kilometers to have a pump filled. The preparation and the analytical control of the mixture are carried out only by those centers meeting the proper criteria, which includes the proper equipment. To spare the patient this travel, a peripheral center may be subcontracted to manage the patient's pump refill. No data are available concerning the chemical stability of admixtures in syringes or polyolefin infusion bags. The aim of this study was to evaluate, with a new analytical method using ultra high-performance liquid chromatography, the chemical stability of these admixtures in syringes or in polyolefin infusion bags. Ziconotide 1 µg/mL was combined with ropivacaine (7.5 mg/mL) and morphine (3.5 mg/mL) in syringes at 5°C, 21°C, and 31°C, and in polyolefin infusion bags at 21°C. Assays were performed using ultra high-pressure liquid chromatography. In syringes stored at 21°C and 31°C, concentrations after 6 hours were not in the acceptable criterion of 10% variability. When syringes were stored at 5°C, the residual concentration of ziconotide after 3 days was 100.5% +/- 2.6% [92.7% to 108.4%]. In polyolefin infusion bags, the residual concentration of ziconotide after 14 days was 96.9% +/- 2.2% [90.1% to 103.6%]. This study demonstrates the chemical stability of this admixture in syringes stored at 5°C for 3 days and in polyolefin plastibags stored at 21°C for 14 days.
D. Monnin - One of the best experts on this subject based on the ideXlab platform.
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Ziconotide adverse events in patients with cancer pain: a multicenter observational study of a slow titration, multidrug protocol.
Pain physician, 2012Co-Authors: D. Dupoiron, François Boré, Daniele Lefebvre-kuntz, Olivier Brenet, Sabine Debourmont, F. Dixmerias, Nadia Buisset, Nathalie Lebrec, D. MonninAbstract:Background Ziconotide is a new analgesic agent administered Intrathecally. It is challenging to use and can induce several and sometimes serious adverse events. A low initial dosage followed by slow titration may reduce serious adverse events. Objective To determine whether a low starting dosage of ziconotide, followed by slow titration, decreases the incidence of major adverse events associated with ziconotide when used for intractable cancer pain. Study design Observational cohort study. Setting Three French cancer centers. Methods Patients with incurable cancer causing chronic pain rated above 6/10 on a numerical scale while receiving high-dose opioid therapy (more than 200 mg/d of oral morphine equivalent) and/or exhibiting severe opioid-related adverse events received Intrathecal infusions of ziconotide combined with morphine, ropivacaine, and clonidine. Results Seventy-seven patients were included. Adverse events were recorded in 57% of them; moderate adverse events occurred in 51%. Adverse events required treatment discontinuation in 7 (9%) including 5 (6%) for whom a causal role for ziconotide was highly likely; among them 4 (5%) were serious. All patients experienced a significant and lasting decrease in pain intensity (by 48%) in response to Intrathecal analgesic therapy that included ziconotide. Limitations Limitations include the nonrandomized, observational nature of the study. Determining the relative contributions of each drug to adverse events was difficult, and some of the adverse events manifested as clinical symptoms of a subjective nature. Conclusions The rates of minor and moderate adverse events were consistent with previous reports. However, the rate of serious adverse events was substantially lower. Our study confirms the efficacy of Intrathecal Analgesia with ziconotide for relieving refractory cancer pain. These results indicate that multimodal Intrathecal Analgesia in patients with cancer pain should include ziconotide from the outset in order to provide time for subsequent slow titration.
Daneshvari R. Solanki - One of the best experts on this subject based on the ideXlab platform.
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Intrathecal catheter-syringe adaptor for short-term Intrathecal Analgesia with an externalized pump: a case report.
Pain physician, 2010Co-Authors: Denise Wilkes, Michael Cook, Daneshvari R. SolankiAbstract:Background In most patients, cancer pain is effectively treated with conservative medical management consisting of oral and/or transdermal analgesics. Cancer patients tend to fail conservative medical management near the end of their life expectancy, thus requiring alternative routes of Analgesia such as intravenous, epidural, or Intrathecal. The Intrathecal route provides the most effective Analgesia due to the close proximity of the opioid receptors in the spinal cord. Though there are many techniques that exist for Intrathecal drug delivery, complications can limit effectiveness such as infection, bleeding, cerebrospinal fluid (CSF) leaks, post-dural puncture headaches (PDPH), pump and/or catheter malfunctions, or limitations of technical expertise. Therefore, an important goal in palliative cancer pain therapy is to use equipment that is going to have the fewest number of complications and will be the most familiar to the health care providers. We describe the combination of the Medtronic Indura 1P catheter, which has the least catheter-related complications and can be used with any external drug infusion pump. These are regular infusion pumps that the health care workers are familiar with so they can provide excellent and efficient service to the patient. Methods In an operating room, the Intrathecal catheter was placed using sterile technique under fluoroscopic guidance. The epidural space was identified with loss of resistance technique. Then the introducer needle (supplied in the Indura 1P catheter kit) was advanced until free-flowing CSF was obtained. The spinal catheter was advanced into the Intrathecal space through the introducer needle to lumbar 2-3 level. The catheter was tunneled subcutaneously 10 cm lateral to the catheter exit site. A syringe filling device was inserted into the catheter opening and was secured with silk suture. A luer lock syringe was attached to the syringe filling device and CSF was aspirated. The syringe filling device was capped and later attached to an external drug infusion pump. Results We report the successful use of the Medtronic Indura 1P, one piece Intrathecal catheter, connected to the external drug pump for a 3 week period in a patient with metastatic cervical cancer for palliative pain control. Limitations Case report only. Conclusion This technique is simple to perform by pain specialists. The catheter modification allows the use of the Medtronic Intrathecal catheter with standard external drug infusion pumps. This facilitates the patient's care in the hospice setting.