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Report of Two Cases: Intrathecal Granuloma Formation with Low Concentrations of Intrathecal Hydromorphone Infusion

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Intrathecal Therapies

Title: Intrathecal Granuloma Formation with Low Concentrations of Intrathecal Hydromorphone Infusion 
Introduction: Chronic intrathecal delivery of opioids leads to concentration and dose dependent growth of granulation tissue composed of inflammatory cells proximal to the catheter infusion site defined as intrathecal “granuloma”. Preclinical data on concentration and dose-dependent hydromorphone induced granuloma formation are available in sheep and beagle dogs. Deer reported that infusion of hydromorphone at concentration of 2 mg/mL and 10 mg/mL resulted in IT granuloma formation in his surveillance report in two patients, respectively. We present two cases of granuloma formation at significantly lower hydromorphone concentrations than described in literature.
Objective: To present and discuss cases of intrathecal granuloma formation at relatively low concentration of hydromorphone.
Case 1: 78 year old female with intractable low back pain due to lumbar post laminectomy syndrome was treated with intrathecal infusion of hydromorphone via an implanted intrathecal delivery device [IDD]. Initial hydromorphone starting dose of 72mcg/day with a concentration of 360 mcg/mL escalated over 12 months to 301mcg/day with a concentration of 750mcg/mL. She developed bilateral lower extremity weakness with uncontrolled lumbar pain, for which an MRI revealed granuloma formation at the catheter tip from T8 to T12. Conservative treatment was initiated with intrathecal infusion of 0.9% normal saline with oral hydromorphone. A repeat MRI 3 months later showed interval resolution of the granuloma, and resolution of her lower extremity weakness and lower back pain.
Case 2: 62 year old female with intractable neuropathic pain post anterior cervical decompression and fusion for severe cervical cord compression with myelomalacia was treated with an intrathecal hydromorphone infusion via an intrathecal pump implant. At implant the starting dose was 50 mcg/day of hydromorphone at a concentration of 500mcg/ml. Over 2.5 years it escalated to 370 mcg/day with a concentration of 750 mcg/ml. She developed worsening back and left sided pain with decreased sensation to temperature and pinprick below T10 level on the left side. An MRI revealed granuloma formation at the catheter tip from T8-9 to T10-11 disc space, and her intrathecal catheter solution was converted to normal saline and pain managed with oral medications.
Discussion/Conclusion: Current prevailing understanding of intrathecal agents that produce inflammatory masses is that intrathecal granuloma formation may be related to relatively high concentrations or doses of opiates. The cases presented here indicate development of granulomas with relatively lower concentrations and doses hydromorphone than what has been described in literature. Vigilance must still be exercised even in this setting for signs suggestive of granuloma formation. Further research is needed to better understand the pathophysiology of intrathecal granuloma formation.
References: Deer T, Krames E, Hassenbusch S, et.al., Management of Intrathecal Catheter-Tip Inflammatory Masses: An Updated 2007 Consensus Statement From An Expert Panel. Neuromod.: Tech. At The Neural Interface. Vol 11. No.2.2008