The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The rate of occurrence of post mastectomy pain syndrome
研究概览
简要总结
This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome
详细描述
Post mastectomy pain syndrome (PMPS) is considered one of the most common types of CPSP with incidence ranging between 20% - 50%.
Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.
Duloxetine is an SNRI that increases serotonin and norepinephrine levels in the central nervous system, which helps modulate pain pathways. Originally developed for depression and anxiety, it is also used for chronic pain conditions such as fibromyalgia, diabetic neuropathy, and chronic musculoskeletal pain.
Amantadine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. These receptors play a significant role in the development of central sensitization, acute opioid tolerance, and opioid-induced hyperalgesia.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •American society of anesthesiologists (ASA) Physical status II, III.
- •Body mass index (BMI): (20-40) kg/m
- •Type of surgery: patients undergoing modified radical mastectomy for breast cancer.
排除标准
- •Patient refusal.
- •Patients with Known sensitivity or contraindication to drug used in the study.
- •History of psychological disorders and/or chronic pain and drug abuse patients.
- •Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Previous breast surgery
研究组 & 干预措施
Group P (Pregabalin group)
Two hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative.
干预措施: Pregabalin (Drug)
Group PA (Pregabalin + Amantadine group)
Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative.
干预措施: Pregabalin + Amantadine (Drug)
Group PD (Pregabalin + Duloxetine group)
Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative.
干预措施: Pregabalin + Duloxetine (Drug)
结局指标
主要结局
The rate of occurrence of post mastectomy pain syndrome
时间窗: 12 weeks post-procedure
The rate of occurrence of post mastectomy pain syndrome will be recorded according to Grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.
次要结局
- Patient's Quality of life(12 weeks post-procedure)
- Patient's activity level(12 weeks post-procedure)
- Degree of pain(12 weeks post-procedure)
- Total amount of fentanyl(Intraoperatively)
- Total amount of morphine consumption(48 hours post-procedure)
- Incidence of side effects related to Pregabalin(48 hours post-procedure)
- Incidence of side effects related to Amantadine(48 hours post-procedure)
- Incidence of side effects related to duloxetine(48 hours post-procedure)
研究者
Hussam Hassan
Assistant Lecturer of Anesthesia, ICU and Pain Management, Cairo University, Cairo, Egypt.
Cairo University