The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Study Overview
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Brief Summary
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The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an effective treatment of the postmastectomy pain syndrome.

Detailed Description
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This study is a randomised, placebocontrolled, doubleblind study on the effect of the antiepileptic drug, levetiracetam, in patients suffering from PMPS. The treatment periods are 1 month each and the periods are separated by a 1-week washout period. The daily dose of levetiracetam is increased over a 2-week period to 3.000 mg/day. The primary effect variable is pain relief by the use of numeric rating scale. Secondary parameters are daily registration of pain performed by the patients during the treatment periods and the amount of escape medicine used (paracetamol and tramadol). Sensory testing is performed at baseline and after each treatment period.

Official Title
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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Levetiracetam (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms characteristic for postmastectomy pain syndrome with a duration of more than 3 months and at least 6 months after the operation. Neuropathic pain diagnose confirmed by abnormities in the neurological investigation and/or psychophysical sensory testing Average (1 week) pain score minimum 4 on a 11 points numerical rating scale for total pain. Pain present minimum 4 out of 7 days. Fertile women must use anticonception. Exclusion Criteria: Verified og suspected other reason than mastectomy/lumpectomy for the pain. Known allergic effects to levetiracetam. Known sideeffects to treatment with levetiracetam. Pregnancy or breast-feeding. Severe disease (terminal cancer, heart failure, kidney insufficiency, severe respiratory problems) Compliance problems

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam (drug)|The starting dose of levetiracetam was 500 mg/day and the dose was increased with 500 mg every other day to 6 tablets of 500 mg (Keppra, UCB, Belgium), divided into two doses daily corresponding to 3000 mg/day. The dose was kept at this level throughout the remaining treatment period - 4 weeks total. Six placebo tablets with identical appearance were dosed similarly to levetiracetam in the placebo phase.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | After 1 month treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured daily on numeric rating scales |  | During treatment periods |