Comparison of Oral Lamotrigine Versus Pregabalin for Control of Acute and Chronic Pain Following Modified Radical Mastectomy: Controlled Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
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)
详细描述
This study will be carried out after being approved from the Medical Research Ethics Committee, faculty of medicine, Assiut University, Assiut, Egypt, and after obtaining written informed consents from all participating patients.
This prospective randomized clinical study will include ninety 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.
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.
According to a random number sequence created by an internet web site (www.random.org), patients will be randomly assigned to three groups (30 patients each):
Group I: patients will receive oral lamotrigine 100 mg 1 hour before surgery with a sip of water.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Salma elkomy
principal investigator
Assiut University