The Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug Delivery Guidance on Safety and Therapy Optimization When Treating Chronic Noncancer Pain.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians and scientists based on expertise with international representation to establish evidence-based guidance on intrathecal drug delivery in treating chronic pain. This Polyanalgesic Consensus Conference (PACC)® project, created more than two decades ago, intends to provide evidence-based guidance for important safety and efficacy issues surrounding intrathecal drug delivery and its impact on the practice of neuromodulation. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when PACC® last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence is scant. RESULTS: The PACC® examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The PACC® recommends best practices regarding intrathecal drug delivery to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Perioperative and Periprocedural Care of Patients With Intrathecal Pump Therapy.

INTRODUCTION: There are an ever-increasing number of patients who have implanted devices for targeted delivery of drug therapy to the intrathecal space for the management of spasticity or chronic pain. This leads to a growing number of people with implanted pumps presenting for procedures and surgeries, yet there is a paucity of consolidated information available to describe the appropriate precautions and patient management during this period. METHODS: This was a systematic review to provide a summary of existing literature on intrathecal drug delivery system (IDDS) management in the perioperative and procedural period, and to highlight additional areas that require further research. Topics addressed include the time surrounding magnetic resonance imaging, defibrillation, radiation therapy, high output ultrasound, lithotripsy, ablation, diathermy, electroconvulsive therapy, and the perioperative period, all of which have their own specific considerations. RESULTS: A total of 42 articles met criteria to be included in this review. Inclusion criteria were English language, and that the article was primarily focused on the perioperative or periprocedural management of IDDSs. Exclusion criteria included commentaries, surveys, published abstracts, or articles that did not discuss the perioperative or periprocedural care of IDDS. CONCLUSION: Our article outlined perioperative considerations when dealing with a patient with intrathecal pump undergoing surgical or imaging modality.

Refill Procedures of Intrathecal Drug Delivery Systems With a Recessed Fill Port on the Pump Surface: A Prospective Comparison Study of Ultrasound-Guided vs. Blind Refill Technique.

OBJECTIVES: Structural differences of implantable drug delivery systems (IDDSs) might have an impact on the efficiency of needle access to the reservoir fill port (RFP). The aim of this study was to assess the efficiency of RFP needle access with an ultrasound (US)-guided vs. a blind refill technique in IDDSs with a Recessed RFP (Recessed-RFP-IDDS). MATERIALS AND METHODS: The primary outcome was the number of attempts needed to enter the RFP with a needle comparing the US-guided technique vs. the blind refill technique. The time to enter the RFP with the needle was a secondary outcome. We compared the amount of attempts between both techniques with the non-parametric Wilcoxon rank sum test. RESULTS: Fourteen adult patients underwent a total of 75 refills of their Recessed-RFP-IDDS during a period of 24 months. The median number of attempts to enter the RFP did not differ significantly between the US-guided technique and the blind refill technique (2.0 (IQR: 1-5) vs. 1.5 (IQR: 1-5.0), p = 0.572). The median time to enter the RFP with the needle did not differ significantly between both techniques (35.0 sec (IQR: 26.0-58.0) vs. 41.0 sec (IQR: 25.5-46.8), p = 0.878). CONCLUSION: The results of this study suggest that there is no difference in the RFP needle access efficiency between the US-guided and the blind refill technique in superficially located Recessed-RFP-IDDSs, if performed by experienced practitioners. However, the study did not address efficiency of the RFP needle access in IDDSs with aberrancy in pump location or refills performed by inexperienced staff.

Efficiency and Safety of Aftercare With Intrathecal Baclofen on Location.

OBJECTIVES: Patients with intractable spasticity treated with intrathecal baclofen (ITB) need regular evaluation and aftercare in an outpatient clinic or pain clinic setting. Logistically, this can be challenging. A solution could be to perform treatment at the patient's home setting. In the Netherlands, a project of the Dutch Healthcare Authority was initiated to deliver ambulatory ITB-related services via a home-based Ambulant Care Clinic. This aftercare is performed by nurse practitioners (NP) with support from a medical specialist. The scope of the study was to investigate the efficiency and safety of ITB-care for patients with severe disabling spasticity in their home setting. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data. Patients with congenital or acquired spasticity were treated with ITB (1st April 2011 to January 1st 2016) using an implanted programmable pump system were referred to the home-based Ambulant Care Clinic by various neuromodulation centers in the Netherlands. All study parameters were a part of the standard intake and follow-up documentation. RESULTS: Of the 900 patients treated with ITB in the Netherlands, 239 were referred to the home-based Ambulant Care Clinic and included in this study. Mean age was 45.5 (range 7-82) years; 52% lived at home; the average satisfaction score was 9 (scale 0-10); and 0.29% had (serious) adverse events (60% of clinical manifestations were prevented by remote double-check control). Certifications for patient safety and quality standards were obtained. CONCLUSIONS: The concept of ITB aftercare on location demonstrated efficacy and safety in the described setting. For troubleshooting, close collaboration with a neuromodulation center is necessary and can be arranged in chain-based care.

Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

Infections of Intrathecal Baclofen Delivery Systems and Ventriculoperitoneal Shunting Systems: Clinical Series Discussion.

BACKGROUND/AIMS: The physiological interaction between the intrathecal baclofen (ITB) delivery system and the ventriculoperitoneal (VP) shunting system in a patient who had both systems implanted has not been reported previously. The aim of our report is to evaluate the effect that one system's infection might have on the other. METHODS: Records of children who were followed at our institution between 2004 and 2015 for management of their ITB systems were reviewed. In this group, children who had VP shunts were identified, and those who had any of their ITB or VP systems infected were included. RESULTS: Out of 313 children managed with ITB therapy at our institution, 31 (24%) children had VP shunts. Two patients had infection in both systems, and 3 patients had infection in 1 system. CONCLUSION: This report suggests that if aspiration from both systems showed positive cultures, the treatment would be removal of both systems. If the primarily not infected system does not show positive cultures, it does not need to be removed. Close follow-up is recommended, and any sign of infection or malfunction of the primarily not infected device should be approached with a high level of suspicion.

The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy.

INTRODUCTION: Intrathecal (IT) drug infusion is an appropriate and necessary tool in the algorithm to treat refractory cancer and noncancer pain. The decision-making steps/methodology for selecting appropriate patients for implanted targeted drug delivery systems is controversial and complicated. Therefore, a consensus on best practices for determining appropriate use of IT drug infusion may involve testing/trialing this therapy before implantation. METHODS: This current Polyanalgesic Consensus Conference (PACC) update was designed to address the deficiencies and emerging innovations since the previous PACC convened in 2012. A literature search identified publications available since the previous PACC publications in 2014, and relevant sources were contributed by the PACC members. After reviewing the literature, the panel determined the evidence levels and degrees of recommendations. The developed consensus was ranked as strong (>80%), moderate (50-79%), or weak (<49%). RESULTS: The trialing for IT drug delivery systems (IDDS) remains an area of continued controversy. The PACC recommendations for trialing are presented in 34 consensus points and cover trialing for morphine, ziconotide, and medication admixtures; starting doses and titration practices; measurements of success; trial settings and monitoring; management of systemic opioids during trialing; and the role of psychological evaluation. Finally, the PACC describes clinical scenarios in which IT trialing is required or not required. CONCLUSION: The PACC provides consensus guidance on best practices of trialing for IDDS implants. In addition, the PACC recommends that no trial may be required in certain patient populations.

The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

INTRODUCTION: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice. METHODS: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012. An extensive literature search identified publications between January 15, 2007 and November 22, 2015 and authors contributed additional relevant sources. After reviewing the literature, the panel convened to determine evidence levels and degrees of recommendations for intrathecal therapy. This meeting served as the basis for consensus development, which was ranked as strong, moderate or weak. Algorithms were developed for intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain. RESULTS: The PACC has developed an algorithmic process for several aspects of intrathecal drug delivery to promote safe and efficacious evidence-based care. Consensus opinion, based on expertise, was used to fill gaps in evidence. Thirty-one consensus points emerged from the panel considerations. CONCLUSION: New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery.

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks.

INTRODUCTION: Intrathecal therapy is an important part of the pain treatment algorithm for chronic disease states. The use of this option is a viable treatment strategy, but it is inherent for pain physicians to understand risk assessment and mitigation. In this manuscript, we explore evidence and mitigating strategies to improve safety with intrathecal therapy. METHODS: A robust literature search was performed covering January 2011 to October 9, 2016, in PubMed, Embase, MEDLINE, Biomed Central, Google Scholar, Current Contents Connect, and International Pharmaceutical Abstracts. The information was cross-referenced and compiled for evidence, analysis, and consensus review, with the intent to offer weighted recommendations and consensus statements on safety for targeted intrathecal therapy delivery. RESULTS: The Polyanalgesic Consensus Conference has made several best practice recommendations to improve care and reduce morbidity and mortality associated with intrathecal therapy through all phases of management. The United States Prevention Service Task Force evidence level and consensus strength assessments are offered for each recommendation. CONCLUSION: Intrathecal therapy is a viable and relatively safe option for the treatment of cancer- and noncancer-related pain. Continued research and expert opinion are required to improve our current pharmacokinetic and pharmacodynamic model of intrathecal drug delivery, as this will undoubtedly improve safety and efficacy.

Solubility and Stability of Baclofen 3 mg/mL Intrathecal Formulation and Its Compatibility With Implantable Programmable Intrathecal Infusion Systems.

BACKGROUND: Commercial baclofen formulations used with infusion pumps are available at therapeutic concentrations of 0.5-2.0 mg/mL. However, patients who receive higher daily doses of baclofen may benefit from products with greater baclofen concentrations since their refill frequency would be reduced (up to a maximum of 180 days). We evaluated baclofen solubility, baclofen 3 mg/mL intrathecal (IT) formulation stability, and chemical and physical compatibility with Medtronic SynchroMed® II and Codman Medstream® programmable IT infusion pumps. METHODS: For solubility evaluations, baclofen powder was dissolved into isotonic saline and tested at 5°C, 25°C, and 40°C. To demonstrate drug product stability, both physical and chemical stability attributes of baclofen 3 mg/mL in prefilled syringes were evaluated over 36 months with storage at 25°C. For a simulated in-use stability (compatibility) study, a 3 mg/mL baclofen IT formulation was placed in SynchroMed II and Codman Medstream pumps at 37ºC for study durations, and evaluated at different flow rates. Pump effluent was collected at various times and analyzed by high-performance liquid chromatography for baclofen content. On completion of the in-use stability study, pumps exposed to baclofen 3 mg/mL were dissected and visually evaluated for signs of deterioration. RESULTS: Baclofen solubility was found to be 3.2 mg/mL at 5°C, 3.6 mg/mL at 25°C, and 3.9 mg/mL at 40°C. During the 36-month stability study of prefilled syringes stored at 25°C, baclofen content remained unchanged and no precipitation was observed. The simulated in-use pump study performed at 37ºC showed that a baclofen 3 mg/mL IT formulation was stable at different flow rates and throughout different expected residence times for both pump models. Components from both pumps exhibited no noticeable deterioration after exposure to the 3 mg/mL formulation. CONCLUSION: Baclofen 3 mg/mL IT formulation was stable during long-term storage at 25°C and remained stable under conditions matching those encountered in clinical practice (37°C).

Best Practices for Intrathecal Baclofen Therapy: Dosing and Long-Term Management.

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. Oral antispasmodics can be weaned, one drug at a time beginning with oral baclofen after ITB begins. Assessment should occur within 24 hours of a dose change. For adults, daily dose increases may be 5% to 15% once every 24 hours for cerebral-origin spasticity and 10% to 30% once every 24 hours for spinal-origin spasticity. Daily dose increases can be 5% to 15% once every 24 hours for children. Inpatients should be assessed at least every 24 hours and receive rehabilitation. Step dosing can be used for outpatients who cannot return daily. Dosing options include simple continuous dosing, variable 24-hour flex dosing, or regularly scheduled boluses. Patients/caregivers should understand the care plan, responsibilities, and possible side-effects. Low-reservoir alarm dates and refill schedules should be written down, along with emergency contact information. A higher concentration at refill can extend refill intervals, and a bridge bolus must be programmed. Time changes may affect flex dosing. Pump replacement should be scheduled at least three months in advance. CONCLUSIONS: ITB dosing is multistep and individualized.

A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain.

OBJECTIVE: The study aims to compare intrathecal (IT) boluses to continuous infusion trialing techniques prior to implantation of drug delivery systems (DDS) for the treatment of severe intractable chronic nonmalignant pain. DESIGN: This is a prospective, randomized, head-to-head long-term outcome study. MATERIALS AND METHODS: Forty patients with comparable patient demographics were randomly assigned to two cohorts. Cohort A trialed with intermittent boluses; Cohort B trialed with continuous infusion. One patient failed trial in each group. Nineteen patients were implanted in each group. Follow-up was for 36 months with intervals at 6, 12, 18, 24, 36 months. The Brief Pain Inventory was used was used for assessment. OUTCOME MEASURES: We used the Brief Pain Inventory to measure pain (worst and average), physical function (walking, normal work, and general activity), behavioral function (mood, sleep, and relations with others), IT dose, and oral opioid use. RESULTS: We observed statistically significant reduction in pain and improvement of function in both cohorts following DDS implantation throughout the observation period. The IT dose remained virtually unchanged throughout as well, with overall limited dose escalation. Oral opioid use was significantly reduced. There was no statistically significant difference in prediction of trial success or long-term outcomes between the two cohorts. CONCLUSION: Low-dose IT opioids via DDS can provide significant and long-lasting reduction in pain, and improvement in function (physical and behavioral) for patients with chronic nonmalignant pain. The two trialing techniques tested, intermittent boluses, and continuous infusion delivered intrathecally showed no clinical significance difference in terms of predicting trial success or long-term outcomes.

Best practices for intrathecal drug delivery for pain.

OBJECTIVE: 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. METHODS: 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. CONCLUSIONS: 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.

Complications of intrathecal baclofen pumps in children: experience from a tertiary care center.

BACKGROUND/AIMS: Intrathecal baclofen (ITB) therapy is useful in treating spasticity and dystonia but it has many complications, more so in children. The main aim of the study was to look at the complications of ITB pumps in children with the goal of future prevention. METHODS: Charts of all patients ≤21 years with an ITB pump, implanted by a single pediatric neurosurgeon, at a single center, between 1996 and 2011 were reviewed retrospectively. Data regarding an ITB test trial were also recorded. RESULTS: During 1996-2011, 119 children (mean age 13.2 years) underwent ITB pump placement; 84% had spastic quadriplegic cerebral palsy. The gross motor function classification system level was ≥4 for most. The pump was removed in 5 (4.2%) patients due to inefficacy. The mean follow-up was 38 months. Mechanical complications requiring pump and/or catheter revision occurred in 19.3% and infections in an additional 21.8%. Seven patients (6%) had meningitis. No complication was noted after 72 months of initial pump insertion, even after pump reinsertion. CONCLUSION: There is a need for better infection control as well as better pump, catheter and surgical technology to lower the complications of ITB pumps in children.

Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel.

INTRODUCTION: The use of intrathecal (IT) infusion of analgesic medications to treat patients with chronic refractory pain has increased since its inception in the 1980s, and the need for clinical research in IT therapy is ongoing. The Polyanalgesic Consensus Conference (PACC) panel of experts convened in 2000, 2003, and 2007 to make recommendations on the rational use of IT analgesics based on preclinical and clinical literature and clinical experiences. METHODS: The PACC panel convened again in 2011 to update the standard of care for IT therapies to reflect current knowledge gleaned from literature and clinical experience. A thorough literature search was performed, and information from this search was provided to panel members. Analysis of published literature was coupled with the clinical experience of panel members to form recommendations regarding the use of IT analgesics to treat chronic pain. RESULTS: After a review of literature published from 2007 to 2011 and discussions of clinical experience, the panel created updated algorithms for the rational use of IT medications for the treatment of neuropathic pain and nociceptive pain. CONCLUSIONS: The advent of new algorithmic tracks for neuropathic and nociceptive pain is an important step in improving patient care. The panel encourages continued research and development, including the development of new drugs, devices, and safety recommendations to improve the care of patients with chronic pain.

Polyanalgesic Consensus Conference--2012: recommendations on trialing for intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel.

INTRODUCTION: Trialing for intrathecal pump placement is an essential part of the decision-making process in placing a permanent device. In both the United States and the international community, the proper method for trialing is ill defined. METHODS: The Polyanalgesic Consensus Conference (PACC) is a group of well-published experienced practitioners who meet to update the state of care for intrathecal therapies on the basis of current knowledge in the literature and clinical experience. Anexhaustive search is performed to create a base of information that the panel considers when making recommendations for best clinical practices. This literature, coupled with clinical experience, is the basis for recommendations and for identification of gaps in the base of knowledge regarding trialing for intrathecal pump placement. RESULTS: The panel has made recommendations for the proper methods of trialing for long-term intrathecal drug delivery. CONCLUSION: The use of intrathecal drug delivery is an important part of the treatment algorithm for moderate to severe chronic pain. It has become common practice to perform a temporary neuroaxial infusion before permanent device implantation. On the basis of current knowledge, the PACC has developed recommendations to improve care. The need to update these recommendations will be very important as new literature is published.

Polyanalgesic Consensus Conference--2012: recommendations to reduce morbidity and mortality in intrathecal drug delivery in the treatment of chronic pain.

INTRODUCTION: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality. METHODS: The Polyanalgesic Consensus Conference is a meeting of experienced implanting physicians who strive to improve care in those receiving implantable devices. Employing data generated through an extensive literature search combined with clinical experience, this work group formulated recommendations regarding awareness, education, and mitigation of the morbidity and mortality associated with intrathecal therapy to establish best practices for targeted intrathecal drug delivery systems. RESULTS: Best practices for improved patient care and outcomes with targeted intrathecal infusion are recommended to minimize the risk of morbidity and mortality. Areas of focus include respiratory depression, infection, granuloma, device-related complications, endocrinopathies, and human error. Specific guidance is given with each of these issues and the general use of the therapy. CONCLUSIONS: Targeted intrathecal drug delivery systems are associated with risks for morbidity and mortality that can be devastating. The panel has given guidance to treating physicians and healthcare providers to reduce the incidence of these problems and to improve outcomes when problems occur.

Polyanalgesic Consensus Conference--2012: consensus on diagnosis, detection, and treatment of catheter-tip granulomas (inflammatory masses).

INTRODUCTION: Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standard part of the algorithm of care. The use of opioids has been associated with noninfectious inflammatory masses at the tip of the intrathecal catheter, which can result in neurologic complications. METHODS: The Polyanalgesic Consensus Conference is a meeting of a group of well-published and experienced practitioners; the purpose of the meeting is to update the standard of care for intrathecal therapies to reflect current knowledge gleaned from literature and clinical experience. An exhaustive literature search was performed, and information from this search was provided to panel members. Analysis of the published literature was coupled with the clinical experience of panel participants to form recommendations regarding intrathecal inflammatory masses or granulomas. RESULTS: The panel has made recommendations for the prevention, diagnosis, and management of intrathecal granulomas. CONCLUSION: The use of chronic infusions of intrathecal opioids is associated with the formation of inflammatory masses at the intrathecal catheter tip in a small minority of treated patients. Nonetheless, the appearance of these space-occupying lesions can lead to devastating neurologic sequelae. The prevention, early detection, and successful treatment of intraspinal granulomas are important considerations when offering intrathecal drug therapy to patients with chronic intractable pain.