• Pain Med · Oct 2012

    Clinical Trial

    Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain.

    • Maged Hamza, Daniel Doleys, Mary Wells, Jackie Weisbein, Jeremy Hoff, Michelle Martin, Costa Soteropoulos, Jose Barreto, Steven Deschner, and Jessica Ketchum.
    • Virginia Commonwealth University Spine Center, Richmond, VA 23235, USA. maged.hamza@gmail.com.
    • Pain Med. 2012 Oct 1;13(10):1304-13.

    Objective  Long-term follow-up with the use of low-dose opioids in intrathecal (IT) drug delivery system (DDS) for the treatment of intractable, severe chronic nonmalignant pain.Design  This is a prospective, cohort long-term outcome study. Intervention.  The intervention was the implantation of DDS.Method And Patients  A total of 61 consecutive patients (60% females, 40% males) with a mean age of 59.2 years and a mean duration of symptoms prior to implant of 6.2 years were referred for implant of DDS for severe intractable noncancer pain. After adequate patient evaluation, each underwent a trial with IT opioids. Three patients failed the trial and 58 patients were implanted. Follow-up was 36 months, with intervals at 6, 12, 18, 24, and 36 months. The Brief Pain Inventory was used for follow-up assessment criteria at baseline prior to implant as well as throughout the duration of the study.Outcome Measures  Outcome measures included self-reported pain scores (worst and average), functional improvement, and IT dose, and oral opioid consumption.Results  We observed a statistically significant reduction in both worst and average pain from baseline (8.91 and 7.47 at baseline) throughout the duration of the study (4.02 and 3.41, respectively, at 36 months) (P = 0.012 and P < 0.001, respectively). We also documented a statistically significant improvement in physical and behavioral function. All subjects showed a significant reduction in the oral opioid consumption. The dose of IT opioids remained low and virtually unchanged for 36 months of follow-up: 1.4 morphine equivalent/day at 6 months and 1.48 at 36 months. Oral opioid averaged 128.9 mg of morphine equivalent/patient/day at baseline to 3.8 at 3 month and remained at the same level throughout the study.Conclusion  Low-dose IT opioid can provide sustained significant improvement in pain and function for long-term follow-up in chronic noncancer pain.Wiley Periodicals, Inc.

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