The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Postoperative Pain Clinical Trial

Official title:

The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262262
• Other study ID #: KIIS
• Secondary ID: PubliRC CNS 085
• Status: Completed
• Phase: N/A
• First received: December 5, 2005
• Last updated: November 21, 2007
• Start date: March 2004
• Est. completion date: September 2006

Study information

• Verified date: November 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of neurology, Odense Universityhospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief		After 1 month treatment
Secondary	Pain intensity measured daily on numeric rating scales		During treatment periods