NCT00383682

Efficacy of Opioids and Mexiletine for the Treatment of Postamputation Pain

Randomized, Placebo-Controlled, Double-Blind Cross-Over Trial of Opioids Versus Mexiletine in the Treatment of Postamputation Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Persistent pain occurs in 50-85 percent of patients who experience the amputation of an extremity. This study will compare the effectiveness of morphine and mexiletine to placebo in the treatment of postamputation pain. It is hypothesized that the effects of opioids and mexiletine on behavior and mental functioning in patients with postamputation pain are unlikely to be significant barriers to the clinical use of the drugs.

Detailed description

The long-term objective of this research is to develop better clinical strategies for alleviating pain resulting from amputation of extremities. Amputation is the most radical form of nerve injury. The two major types of postamputation painful sequela are phantom pain and stump pain. Phantom pain has been defined as painful sensation perceived in the missing body part, or portion thereof (Merskey and Bogduk,1994). Phantom pain is the most distressing, and often difficult to treat, chronic neuropathic pain syndrome that results from direct injury to the peripheral or central nervous system. Recent epidemiological studies indicate that 50-85% of patients experience persistent pain following amputations. This controlled clinical trial will examine the role of opioid analgesics and local anesthetics in the treatment of phantom and associated stump pain resulting from amputations. Specifically, our objectives are to answer the following questions: 1. Does therapy with opioids and mexiletine result in better management of postamputation pain than treatment with placebo? Using a randomized, blinded, crossover clinical trial, the effectiveness of therapy with the opioid, morphine, and the oral local anesthetic, mexiletine, will be compared with placebo in the management of phantom and associated stump pain following amputations. The effectiveness of the treatment regimens will be judged by improvements in: a) The intensity of ongoing, stimulus-independent pain using established pain intensity and pain relief scales, b) Stimulus-evoked pain using quantitative sensory tests, and c) Impairment of function using established measures. 2. What are the relative effects of opioids and mexiletine on affective and cognitive function in patients with amputated extremities? Using established tests of neuropsychological function, mood, and psychosocial and physical impairment, affective and cognitive changes associated with the opioid and mexiletine therapies will be quantified and compared with changes associated with placebo treatment. These studies will help determine if the effects of opioids and mexiletine on affect and cognition are likely to limit the usefulness of the medications in the treatment of pain following amputations.

Conditions

• Amputation
• Chronic Pain

Interventions

Type	Name	Description
DRUG	morphine and mexiletine

Timeline

• Start date: 1997-07-01
• Completion: 2003-04-01
• First posted: 2006-10-03
• Last updated: 2006-10-03

Locations

1 site across 1 country: United States