The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Odense University Hospital25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain

Interventions

Levetiracetam (drug)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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of neurology, Odense Universityhospital

Odense, Fyn, Denmark

Outcomes

Primary Outcomes

Pain relief

Time frame: After 1 month treatment

Secondary Outcomes

Pain intensity measured daily on numeric rating scales

Time frame: During treatment periods

Data from ClinicalTrials.gov

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