Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Visual analogue scale
研究概览
简要总结
This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.
详细描述
75 Patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: Group P: will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Group D:will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast .
Group C: will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.
The total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 &24 hours and Visual analogue scale at 0, 2,4, 8, 12, 16 &24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Physical status ASA II, III.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 40 kg/m
- •Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or metastatectomy from the lung.
- •Patient is able to provide a written informed consent.
排除标准
- •● Patients with Known sensitivity or contraindication to drug used in the study
- •History of psychological disorders and/or chronic pain.
- •Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- •Patient refusal.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
研究组 & 干预措施
Group Pregabalin
Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
干预措施: Pregabalin (Drug)
Group Duloxetine
Patients will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast .
干预措施: Duloxetine (Drug)
Group Pregabalin& Duloxetine
Patients will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.
干预措施: Pregabalin (Drug)
Group Pregabalin& Duloxetine
Patients will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Visual analogue scale
时间窗: 24 hours postoperative
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- Visual analogue scale(12 weeks)
- Total dose of intraoperative fentanyl.(2 hours intraoperative)
- Heart rate(24 hours)
- Mean arterial pressure(24 hours postoperative)
研究者
Bassant M. Abdelhamid
Associate professor
Cairo University