The Korean Journal of Pain

The Long-Term Safety and Efficacy of Intrathecal Therapy Using Sufentanil in Chronic Intractable Non-Malignant Pain

Additional article information

Abstract

This report describes the long term safety and efficacy of intrathecal therapy using Sufentanil for the management of chronic intractable neuropathic pain in 12 chronic pain patients. Standardized psychological screening was used to determine treatment suitability. Evaluation data included the Visual Analog Scale (VAS), Wong-Baker Faces Scale, Brief Pain Inventory (BPI), Disability of Arm, Shoulder, and Hand (DASH), McGill Quality of Life Questionnaire, and complications (granulomas, toxicity, withdrawal, or deaths). SPSS version 18 was used for data analysis. Pre- and post- treatment BPI measures and pain scale scores showed a statistically significant difference. There were no complications directly related to drug toxicity, nor drug withdrawals, granulomas, or deaths. Intrathecal therapy with Sufentanil therapy offers a good treatment alternative for those cases that have failed both 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.

Keywords: implantable infusion pump, intractable pain, neuropathic pain, sufentanil

METHODS

1. Pre/post measures

Baseline data included pain self-report ratings using a Visual Analog Scale (VAS), the Wong-Baker Faces Scale, the Brief Pain Inventory (BPI), and the Disability of Arm, Shoulder, and Hand (DASH). These same ratings were also collected at follow-up.

The VAS uses an equidistant 0-10 rating scale (no pain to worst pain possible) on a 100-mm line, and is commonly used in clinical practice. However, since the VAS is a one dimensional measurement, other measures must also be used to capture the multi-dimensional nature of pain. Research suggests that faces pain scales may be reliable and valid for use in adults, and can provide an added measurement component when literacy or understanding of English may compromise results of other measures [6]. The Wong-Baker Faces Scale provides an excellent supplemental measure for the multicultural population in this sample.

The BPI is a measure used to assess the severity and location of pain, the impact of pain on daily functions, pain medications being used, and pain relief obtained during the past 24 hours or past week. The BPI uses numeric rating scales that range from 0 to 10. Mild pain is defined as a pain score of 1-4, moderate pain as a score of 5-6, and severe pain as a score of 7-10 (http://www3.mdanderson.org/epts./prg/bpi.htm#detail_descript).

The DASH measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. Scoring is divided into two sections: (a) disability and symptoms (30 items, scored 1-5) and an optional sport/music or work section (4 items, scored 1-5) (http://www.dash.iwh.on.ca/).

2. Outcome measures

In addition to the above measures, the McGill Quality of Life Questionnaire was used as an outcome measure. It is a patient-reported instrument that was designed to measure quality of life in populations with life-threatening illnesses. Subscale scores and overall index scores can range from 0 to 10, helping to identify areas that need attention if the score is low. This measure was chosen to supplement the outcome results.

Complications such as equipment problems, granulomas, toxicity, withdrawal, or deaths were reviewed. CT myelograms were used to detect any asymptomatic catheter granulomas. All data were analyzed using SPSS version 18.

RESULTS

1. Pre/post measures

At pre-treatment baseline, the overall average BPI score was 77, and the mean was 80. Following treatment, overall scores were improved by 35% and paired T-test results showed statistical significance at a P value of 0.0068. At pre-treatment baseline, the overall average DASH score was 73.2 with a mean of 78 (Only five patients had upper limb pain, which is why only 5 are reported taking the DASH). Following treatment, overall scores were improved by 38% and paired T-test results showed statistical significance at a P value of 0.0259. At pre-treatment baseline, the overall average VAS score was 7.7, and the mean was 8. Following treatment, overall scores were improved by 20% and paired T-test results showed statistical significance at a P value of 0.0045. The 20% improvement in pain intensity demonstrates minimally important changes [7]. At pre-treatment baseline, the overall average Wong-Baker score was 4.2, and the mean was 4. Following treatment, overall scores were improved by 10% and paired T-test results showed statistical significance at a P value of 0.0069 (Table 1).

Table 1

2. Outcome measures

1) McGill quality of life questionnaire

Complications were limited to one catheter recall and one pump recall. One pump had to be replaced early for motor stall. There were no granulomas, toxicity, withdrawal, or deaths (Table 2).

Table 2

DISCUSSION AND CONCLUSION

In the larger cohort of 19 patients, a total of 47 pumps have been implanted. In the 12 patient group, 42 pumps with Sufentanil have been implanted without complications related to toxicity, drug withdrawals, granulomas, or deaths. The pain improvement of greater than 30% is clinically significant 7 and had a positive impact on quality of life.

Intrathecal therapy using Sufentanil offers an acceptable treatment alternative for those cases that have failed both surgery and standard pain treatment including dorsal spinal cord stimulators. Strict patient selection based on psychological screening, control of co-morbidities, and proper pain management may contribute to successful outcome.

Article information

The Korean Journal of Pain.Jul 31, 2014; 27(3): 297-300.
Published online 2014-06-30. doi:  10.3344/kjp.2014.27.3.297
Hand and Microsurgery Center of El Paso, Orthopedics and Rehabilitation, Texas Tech University Health Science Center (TTUHSC), Texas, USA.
Correspondence to: Jose Jesus Monsivais. Hand and Microsurgery Center of El Paso, Orthopedics and Rehabilitation, Texas Tech University Health Science Center (TTUHSC), 10175 Gateway West, Suite 230, El Paso, Texas 79925, USA. Tel: +1-915-590-3666, Fax: +1-915-590-3667, handmicro@msn.com
Received: June 11, 2014.
Accepted: June 13, 2014.
Articles from The Korean Journal of Pain are provided here courtesy of The Korean Journal of Pain

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Table 1

Pre and Post Treatment BPI, DASH, VAS, and Wong-Baker Scores

Table 2

McGill Quality of Life Questionnaire Scores