The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT00262262
• Lead Sponsor: Odense University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-06
• Study Completion: 2006-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-21
• Last Update Posted: 2007-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain relief	After 1 month treatment

Secondary Outcome Measures

Name	Time	Method
Pain intensity measured daily on numeric rating scales	During treatment periods

Trial Locations

Locations (1)

Department of neurology, Odense Universityhospital; 🇩🇰 Odense, Fyn, Denmark