American Society for Peripheral Nerve

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The Long Term Safety and Efficacy of Intrathecal Therapy Using Sufentanil in Chronic Pain
Jose J. Monsivais, MD,
Hand and Microsurgery Center of El Paso, El Paso, TX and Diane Monsiv¬ais, PhD, School of Nursing, University of Texas at El Paso, El Paso, TX

INTRODUCTION: The purpose of the study is to describe the long term safety and efficacy of intrathecal therapy using Sufentanil for the management of chronic neuropathic pain including failed back surgery syndrome.

METHODS: This was a retrospective review of a pre-designed cohort study. Nineteen (19) patients with chronic non-malignant pain who had failed standard treatment, used high doses of opioids for greater than 2 years, and were suitable candidates for intrathecal therapy were included. Twelve (12) patients had long-term follow-up on Sufentanil (range 20 months -14 years, average 5 years).

Standardized psychological screening was used to assess suitability. After pump implantation using standard technique, the catheter was placed at the lower thoracic spine level between T8-T11. Pumps were refilled at 30-80 day intervals (dose ranges between 25-55 mcg/of sufentanil/day). pH was measured on all fluids at pump refill. CT myelograms were used to detect asymptomatic catheter granulomas. Routine neuropathy blood work was done every 3 months

The Brief Pain Inventory (BPI), Disabilities of the Arm, Shoulder and Hand (DASH), and pain scales were used for pre and post-treatment assessment using paired t-tests (SPSS v. 18).

The McGill Pain Questionnaire Outcome Measure and SF-36v 2 were used for outcome assessment.

RESULTS: A total of 47 pumps were implanted in 19 patients, and 42 pumps with Sufentanil were implanted in 12 patients.

Pain improvement was >30% and there was a positive impact on Quality of Life.

Statistically significant results were obtained for pre –post treatment measures for BPI, DASH, VAS and Wong-Baker scales. There were no complications directly related to drug toxicity.

Total patient years of treatment was 61.5 years.

The complication rate was low and included catheter recall (1), pump recall (1), pump motor stall (1), and pocket refill (1). There were no other complications (toxicity, withdrawals, granulomas, or deaths).

DISCUSSION AND CONCLUSION: Intrathecal therapy with Sufentanil therapy offers a good treatment alternative for those cases that have failed surgery and standard pain treatment. Strict patient selection based on psychological screening, control of co-morbidities, a proper pain management may contribute to successful outcome.


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