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Trial record 35 of 215 for:    Lamotrigine

Comparison of Oral Lamotrigine and Oral Pregabalin for Control of Acute and Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03419949
Expanded Access Status : Available
First Posted : February 2, 2018
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Salma elkomy, Assiut University

Brief Summary:

Breast cancer is the most frequent neoplastic tumor in women, and surgical treatment is indicated in most patients. Complications related to this treatment, such as post-mastectomy pain syndrome (PMPS), a persistent pain that develops after surgery, have been reported. Although the genesis of the pain is multifactorial, sectioning of the intercostobrachial nerve is the nerve lesion diagnosed more often (1) ..

Pain relief using drugs with high efficacy provides significant improvement in the patients' lives. Drugs like lamotrigine (LTG) and gabapentin (GBP) have the ability to overcome the symptoms of neuropathic pain (4).

Both LTG and PGB have been extensively reviewed in the past for management of painful neuropathic conditions (5)

Condition or disease Intervention/treatment
Acute and Chronic Pain Following Modified Radical Mastectomy Drug: oral lamotrigine 100 mg Drug: oral pregabalin 150 mg

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Comparison of Oral Lamotrigine and Oral Pregabalin for Control of Acute and Chronic Pain Following Modified Radical Mastectomy

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: oral lamotrigine 100 mg
    Pain relief drug Lamotrigine inhibits the voltage-gated sodium and calcium channels. Inhibition of the voltage-gated sodium channel stabilizes the presynaptic neuronal membrane, thus preventing the release of excitatory neurotransmitters such as glutamate and inhibiting sustained repetitive neuronal firing
    Other Name: lamictal
  • Drug: oral pregabalin 150 mg
    Pain relief using drug Pregabalin is a structural analogue of the inhibitory neurotransmitter gama-aminobutyric acid (GABA), with anticonvulsant, antihyperalgesic, and anxiolytic properties
    Other Name: lyrica

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female patients with ASA I-II, aged 18-60 years, have BMI < 30 km\ m2 and scheduled for modified radical mastectomy with axillary dissection for management of breast cancer

Exclusion Criteria:

- Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory , renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03419949

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Contact: salma komy 01069572290

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Salma Komy
Assiut, Egypt
Sponsors and Collaborators
Assiut University

Additional Information:

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Responsible Party: Salma elkomy, principal investigator, Assiut University Identifier: NCT03419949     History of Changes
Other Study ID Numbers: Comparison of oral lamotrigine
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Keywords provided by Salma elkomy, Assiut University:
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Sodium Channel Blockers