Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post laparoscopic shoulder pain
研究概览
简要总结
Despite recent advances in minimal invasive surgery, postoperative pain control remains a challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is minimally invasive, has less pain, and needs less postoperative analgesic use compared with open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure
详细描述
Many patients may feel much more discomfort from their shoulder pain than incision pain . Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and phrenic nerve by local acidosis and irritative effect of carbon dioxide during pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and since duloxetine is an antineuropathic pain medications we assume its use will ameliorate diaphragmatic irritation and hencepost laparoscopic shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal females
- •Patient consent
- •Patients with ASA class I-II
- •Elective gynecological laparoscopy
排除标准
- •Body Mass Index ≥ 40
- •Consuming any pain killers routinely within 48 hours before the surgery
- •Smoking, drug abuse
- •Patients with major psychiatric disorders, epilepsy or history of convulsion
- •Any known kidney or hepatic disorders
- •History of any other pervious laparotomy, laparoscopy, or other pelvic manipulation or pathology except normal vaginal delivery
- •History of chest or mediastinal surgery or pathology
- •Recent flu (six weeks before surgery)
- •Suspected to malignancy as pathology
- •Those who complained from shoulder pain just before surgery in the first Visual Analog Scale assessment.
研究组 & 干预措施
case group
Duloxetine 60mg orally 12 hours before surgery
干预措施: Duloxetine 60mg (Drug)
Control group
Placebo (glucose powder in a tablet) orally 12 hours before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
post laparoscopic shoulder pain
时间窗: 12 hours after surgery
The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale
次要结局
- sedation(12 hours after surgery)
研究者
mina fayez ghalyoom
principal invstigator
Assiut University