• Neuromodulation · Oct 2020

    Randomized Controlled Trial Comparative Study

    A Comparison of Refill Procedures and Patient Outcomes Following Ultrasound-Guided and Template-Guided Intrathecal Drug Delivery Systems With Recessed Ports.

    • Ramesh M Singa, Asokumar Buvanendran, and Robert J McCarthy.
    • Napa Pain Institute, 3434 Villa Lane, Suite 150, Napa, CA, USA.
    • Neuromodulation. 2020 Oct 1; 23 (7): 938-943.

    ObjectiveIntrathecal drug delivery systems (IDDS) are refilled using templates and palpation. The 2017 Polyanalgesic Consensus Conference recommends ultrasound only when reservoir ports are difficult to identify. The purpose of this study was to compare procedural outcomes and patient's preference for refill method of IDDS.Materials And MethodsThe study was approved by the Rush University IRB. Participants were randomized to have their IDDS with ultrasound or template using a 2:1 allocation. The time to reservoir port access, number of needle maneuvers/punctures, pain (NRS 0-10), complications, patient satisfaction, and patient refill modality preference, were recorded.ResultsA total of 107 patients underwent 192 refills. There were 67 template-guided refills and 125 ultrasound-guided refills. No procedural pain (NRS = 0) was reported in 84% of the ultrasound-guided refills compared with 67% of the template-guided procedures, difference - 17% (95% difference - 3% to -31%, p = 0.01). When adjusted for age, gender, procedure duration, needle sticks, needle maneuvers and refills in the same patient, the odds ratio for a pain-free procedure with ultrasound-guidance was 3.1 (95% CI 1.3 to 7.2, p = 0.01). There was no difference between the groups in needle punctures (p = 0.87) or redirections (p = 0.34). Following 35/67 (52%) template-guided procedures, patients stated they preferred the ultrasound-guided but following only 12/125 (10%) of ultrasound-guided procedures, patients stated they preferred template-guidance (p < 0.001).ConclusionsPatients preferred ultrasound even though it lengthened the duration of refills compared to template-guided procedures. Fewer patients experienced procedural pain with ultrasound compared with template-guided refills. No safety issues were observed in either group.© 2019 International Neuromodulation Society.

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