Postoperative PainNCT00262262
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
A study testing Levetiracetam (drug) in people with Postoperative Pain, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Levetiracetam (drug)
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of neurology, Odense Universityhospital
Odense, Fyn, 5000
About this study
The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an effective treatment of the postmastectomy pain syndrome.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Levetiracetam (drug)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam (drug)Drug
Also called Keppra, Levetiracetam
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 being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: After 1 month treatment
Secondary outcomes (1)
Pain intensity measured daily on numeric rating scales
Measured: During treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startMar 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ole J Vilholm, MD, Study director, Odense University HospitalSøren H Sindrup, Professor MD, Principal investigator, Odense University HospitalSøren Cold, MD, Study chair, Department of oncology, Odense University Hospital, DenmarkLars Rasmussen, MD, Study chair, Department of surgery, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262262
- Sponsor's protocol ID
- KIIS
- Other IDs
- PubliRC CNS 085 TA 1007 LEV
- Status last verified
- Nov 2007
- First submitted
- 5 Dec 2005
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT00262262
- Acronym / sponsor ID
- KIIS
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam (drug)Also: Keppra, LevetiracetamThe 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. | Drug | – |
Primary outcome
Pain relief
Time frame: After 1 month treatment
1 secondary outcome
Pain intensity measured daily on numeric rating scales
Time frame: During treatment periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2007.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole J Vilholm, MD study director
Odense University Hospital
Søren H Sindrup, Professor MD principal investigator
Odense University Hospital
Søren Cold, MD study chair
Department of oncology, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam (drug) in people with Postoperative Pain, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: After 1 month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2007.