Intrathecal Pain Therapy Research Articles

Intrathecal therapy for pain in cancer patients.

Intrathecal drug delivery systems (IDDS) for cancer pain remain little employed despite a high level of efficiency even though the technique is widely recommended. This review aims to summarize recent advances in IDDS for cancer patients. The respective roles of catheter positioning, volume and flow rate in diffusion of intrathecal treatments, as well as the individual roles of blood pressure, heart rate, and amplitude of the respiratory movements in cerebrospinal fluid (CSF) treatment dispersion, are now well established. Models are available using MRI data. Morphine has long been the gold standard in first line treatment, but recent publications conclude that ziconotide has largely proven its efficiency and that adverse effects are controllable. Four recent publications have evaluated cohorts of cancer patients treated by IDDS in 315 patients. All found a great efficiency of intrathecal treatment for cancer pain. Technical innovations include new catheters and anchorage devices for easier placement and a lower rate of complication. Three-dimensional (3D) CT scan appears to be a noninvasive technique for the diagnosis of catheter complications. Ultrasound should be used to locate pump septum for refill. All recent recommendations highlight the efficiency of IDDS and propose to use it sooner.

Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patients' Global Perceived Effect in Intrathecal Therapy for Pain: A Randomized Double-Blind Crossover Study.

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. 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. The primary outcome measure was the Patients' Global Impression of Change (PGIC) scale. The mean proportion of positive responders (at least "minimally improved") was 38.4% in the continuous condition vs 37.3% in the bolus (difference in proportions = 1.1%, 95% confidence interval [CI] = -21.8-24.0%, P = 0.93). The mean PGIC in the continuous condition was 3.8 vs 3.9 in the bolus (mean difference = -0.1, -0.6-0.4, P = 0.72). Exploratory analyses revealed a tendency for the mean proportion of positive responders to be higher at low vs high flow rates for both bolus and continuous administrations. Two patients were withdrawn from the study due to adverse events during the bolus phase, both with symptoms of increased pain, and one patient with additional symptoms of numbness and urinary retention. The mean PGIC and proportion of positive responders was not substantially different after intermittent bolus vs continuous administration.

Best Practices for Intrathecal Drug Delivery for Pain

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.

Importance of intrathecal pain therapy

Intraspinal drug infusion using implantable pumps and catheter systems is a safe and effective therapy for selected pain patients with severe chronic pain. It improves pain relief, reduces drug-related side effects, decreases the need for oral analgesia and enhances quality of life in a segment of chronic pain patients whose pain has not been controlled with more conservative therapies. Intrathecal drug therapy has therefore established its role in the treatment of malignant pain, benign pain and severe spasticity.Careful patient selection and management as well as a multidisciplinary approach are determinants of successful treatment. Current practices for patient selection and management, screening, drug selection, dosing and implantation for intrathecal drug delivery systems are discussed.

Patient-controlled Analgesia in Intrathecal Therapy for Chronic Pain: Safety and Effective Operation of the Model 8831 Personal Therapy Manager with a Pre-implanted SynchroMed Infusion System

The Model 8831 Personal Therapy Manager (PTM) offers a patient-controlled analgesia (PCA) option for the SynchroMed Infusion System (Medtronic Inc., Minneapolis, MN). The safety and effective operation of the PTM activator was evaluated in 45 patients in five European centers receiving intrathecal drug infusion for the treatment of chronic pain via a SynchroMed pump. The total volume of drug delivered intrathecally over a four-week follow-up period was calculated. Adverse events were recorded and pain levels were measured via the Visual Analog pain Scale (VAS), Brief Pain Inventory, and SF-12 Quality of Life scores. Patient satisfaction with the device and its instruction manual was also assessed by questionnaire. The expected and calculated intrathecal drug volumes (and therefore drug doses) were the same, demonstrating that the device worked as intended. There were no device-related serious adverse events. Overall, 96% of patients were satisfied with the activator. Patients appreciated being able to control their pain and considered the device and its instructions easy to use. The PTM was shown to be safe and functioning properly in the intrathecal treatment of pain. The successful addition of a PCA function to the SynchroMed system may create a new standard in intrathecal pain therapy.

Pain therapy near the spinal marrow. Status survey in Germany and Austria

The objective of this survey was to investigate the current status of the epidural and intrathecal management in patients with chronic cancer and non-cancer pain in Germany and Austria. In June 1997 a questionnaire was sent to 598 German and Austrian anaesthesiologists specialized in pain therapy. Questions concerning the use of medicaments for epidural and intrathecal treatment of chronic pain were asked. The response rate was 23%. The data show that 78% of the anaesthesiologists use epidural or intrathecal analgesia in the therapy of chronic pain. Local anaesthetics are used by 85% of these anaesthesiologists, followed by morphine (72%), clonidine (48%), buprenorphine (34%), baclofen (20%), fentanyl (13%) and sufentanil (10%). For most of the treatments local anaesthetics are used, again followed by opioids und clonidine. In the 137 answering pain clinics 79.821 epidural and intrathecal analgetic treatments are performed per year. Epidural and intrathecal pain therapy is frequently used in Germany and Austria, either as a complementary or alternative treatment to systemic pain therapy. Local anaesthetics followed by opioids are the most commonly used medicaments for this treatment. For some of the applied substances neurotoxicological data are lacking. The use of these substances has to be considered very carefully.

Cost Effectiveness of Intrathecal Therapy for Pain

Successful management of chronic cancer and nonmalignant pain remains a challenge to clinicians, and cost effectiveness is an important consideration for clinical decision making. Although the oral route was previously considered the optimal method of chronic opioid administration, emerging evidence demonstrates a therapeutic advantage to intrathecal opioid delivery compared to alternative modalities. Intrathecal drug delivery uses an implantable drug infusion system to deliver very low doses of opioids and other analgesics directly into the intrathecal space. Although the initial costs of surgical implantation of an intrathecal pump appear to be substantial, maintenance costs of intrathecal drug delivery over time are significantly lower than other routes of administration, including oral and intravenous drug delivery. Cost analyses of alternate routes of opioid administration indicate that intrathecal delivery is the most cost-effective route of opioid administration for patients who require long-term management of cancer (≥ 3-6 months) or nonmalignant pain (≥ 11-22 months).

Alternative Intrathecal Agents for the Treatment of Pain

There is a need to develop alternative agents for intrathecal pain therapy for patients who either cannot tolerate the side effects of or who no longer obtain sufficient analgesia with opioids. The experimental use of several compounds in intrathecal drug delivery is currently in progress, with the development of clonidine as the single most important advance in the improvement of pain treatment. Clonidine, an α(2) -adrenergic receptor agonist, appears to be safe and effective in the treatment of cancer and nonmalignant pain, with its effects most pronounced in patients whose pain consists of a neuropathic component. Other possible effective agents for intrathecal delivery include bupivacaine, octreotide, and SNX-111. The preclinical and clinical profiles for these promising new intrathecal pain medications are discussed.

Intrathecal Therapy for Cancer and Nonmalignant Pain: Patient Selection and Patient Management

Intrathecal drug delivery improves pain relief, reduces suffering, and enhances quality of life in the small proportion of patients who do not respond well to oral analgesics, including oral morphine. Although morphine is the "gold standard," and the only drug approved for intrathecal pain therapy in the United States, off-label use of alternative agents appears promising, particularly in patients with neuropathic pain. Careful patient selection and management are significant determinants of successful treatment outcomes. Patient selection criteria for cancer and nonmalignant pain are similar; however, a more comprehensive psychological and social assessment is required for patients with nonmalignant pain. In addition, all patients (those with cancer or nonmalignant pain) must exhibit a positive response to an epidural or intrathecal screening test. A multidisciplinary team approach, involving psychologists, nurses, physical therapists, social workers, and spiritual leaders should be used to manage patients. Current practices for patient selection and management, screening tests, and dosing guidelines for intrathecal drug delivery systems are discussed.