Comparison of Duloxetine Versus Pregabalin in Post-mastectomy Pain Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- visual analogue score
研究概览
简要总结
Chronic post mastectomy pain syndrome (PMPS) is a chronic post-surgical neuropathic pain following breast cancer surgeries and lasting more than three months after surgeries. Pregabalin is originally used as an antiepileptic drug and identified as treatment for neuropathic pain .There are several recent reviews have revealed that it reduces post-operative opioid consumption and improves pain scores after breast surgeries. Duloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system and used for treatment of neuropathic pain conditions as painful diabetic neuropathy, neuropathic pain of lung cancer and chemotherapy induced sensory neuropathy
详细描述
Patients with of 3 months of chronic neuropathic pain after breast surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection is considered as post mastectomy pain syndrome which is defined as pain involving the anterior aspect of the chest, axilla, and/or upper arm with the classical features of neuropathic pain including numbness, tingling, burning, shooting, stinging, or stabbing pains, and hyperesthesia.
- They are divided to 2 equal groups: ( Group A) receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks .
- Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours )
- Randomization and blinding: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
- Concomitant therapy :opioid therapy according to WHO step ladder in cancer pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, history of breast surgery and patients with post mastectomy pain
排除标准
- •pregnancy,history of allergy to Pregabalin or duloxetine, pregnancy or lactation, history of pregabalin or gabapentin intake in the preceding three months, history of radiotherapy and history of drug abuse
研究组 & 干预措施
( Group Duloxetine )
• Dosing and administration (Group A) Duloxetine 30 mg /day oral intake at bed time
干预措施: Duloxetine (Drug)
(Group Pregablin )
control group Pregablin 150mg /day( 75 mg /12 hours ) oral intake.
干预措施: Pregablin (Drug)
结局指标
主要结局
visual analogue score
时间窗: baseline till 12 weeks of treatment
visual analogue score with least pain score is 0 and worst pain is 10
次要结局
未报告次要终点
研究者
Mohammed Abdelfattah Abdelwadod
Mohammed Abdelfattah Abdelwadod
National Cancer Institute, Egypt