NCT07567924已完成4 期
A Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome: A Single-blinded Randomized Controlled Trial
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Subas Ali
- 入组人数
- 158
- 试验地点
- 1
研究概览
简要总结
The goal of this trial is to learn if Pregabalin is better than Acetaminophen in pain management of patients with Post-Mastectomy pain Syndrome, which is defined as pain in the scar, chest wall, shoulder after undergoing mastectomy or breast-conservation (BCS). It could be burning, stabbing, shooting pain or pins-and-needle sensation.
Participants will:
- Take their prescribed allotted medicine for 14 days.
- Will visit the clinic at 2 and 6 week interval for assessment.
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
- Single (Participant)
盲法说明
The person analyzing the data will be blinded to allocation.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All diagnosed cases of post mastectomy pain syndrome
- •Patients developing radiation dermatitis grade 0 and 1
排除标准
- •Patient undergoing toilet mastectomy
- •Patient developing radiation dermatitis grade 2, 3 and 4
- •Patients with convulsions
- •Patients with known pregabalin hypersensitivity (lightheadedness , sedation , double vision ,increase in bodyweight and imbalance)
- •Patients with known acetaminophen hypersensitivity (urticaria, bronchospasm, anaphylaxis)
- •Patients with renal failure
- •Patients with hepatic dysfunction/ hepatic disease
- •Patients with prior use of pregabalin due to chronic pain conditions within 3 months
- •Pregnant or lactating
- •Neuropsychiatric disorders
研究组 & 干预措施
Pregabalin
Experimental
1 tablet of 75 mg administered once daily at night for 14 days without interruption
干预措施: Pregabalin (Drug)
acetominophen
Active Comparator
1g of acetaminophen is administered thrice daily for 14 days without interruption
干预措施: Acetaminophen (Drug)
研究者
Subas Ali
Senior Registrar
Sindh Institute of Urology and Transplantation
研究点 (1)
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