Intrathecal inflammatory masses: is the yearly opioid dose increase an early indicator?

Long-term Intrathecal Drug Administration for Chronic Nonmalignant Pain

“…A cure for pain in patients undertaking IDDS is unlikely; therefore, one of the most important outcomes in these patients is improvement in quality of life. 40 Despite the side effects and complications identified, the majority of patients (90%) revealed satisfaction with the treatment and considered IDDS to be worthwhile. Significant improvements in activity levels, depression, and quality of life after implantation of IDDS are consistent with previous reports.…”

Polyanalgesic Consensus Conference—2012: Consensus on Diagnosis, Detection, and Treatment of Catheter-Tip Granulomas (Inflammatory Masses)

“…There are no data from controlled trials that document factors governing the formation of IT granulomas in patients receiving IT drug delivery for treatment of chronic pain. A single rigorous retrospective analysis was identified (13), as well as 12 case reports (2,17–26). Descriptive case reports are the primary sources of information about these granulomas.…”

“…According to results from an online survey that was developed to coincide with the 2007 PACC, 63.9% of physicians reported that at least one of their patients had developed a granuloma (12,13). In a retrospective analysis of hospital medical records, at a mean postimplantation follow‐up time of 91 months (range, 9–209 months), 4 cases of IT granuloma occurred among 56 patients who received IT opioids, an incidence of 7% (13). In a retrospective cohort study with a three‐year follow‐up, ≥3.5% of 57 patients who received IT opioid therapy for chronic nonmalignant pain had a granuloma (11).…”

“…Although granuloma formation is still thought to be an infrequent event in patients who undergo IT drug administration, reports of inflammatory masses are increasing. This increase may reflect the rising incidence of this potentially serious adverse event, as evidenced by postmarketing surveillance reports from Medtronic, Inc. (9,10), and by the increasing number of case reports and retrospective surveys of granuloma formation that have appeared in the literature since this phenomenon was first described (2,11–15). The seriousness of this adverse event is underscored by the finding that, among clinicians who have treated at least one patient with a granuloma, 66% reported having a patient who experienced permanent or temporary neurologic injury as a result of granuloma formation (12).…”

The Delayed Appearance of Neurological Signs in Intrathecal Granuloma Warrants Imaging Surveillance: A Case Series and Review of the Literature

“…Inflammatory mass, or granuloma, is a complication that can be potentially devastating. Published reports regarding inflammatory mass often refer to catheter tip masses as rare or uncommon 4,5 . According to the leading manufacturer of ITP equipment (Medtronic), the reported incidence of granuloma is 0.49% in a given population of ITP patients 6 .…”