Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
研究概览
简要总结
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
详细描述
Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study
排除标准
- •Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.
研究组 & 干预措施
Group C (control)
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
干预措施: Placebo (Drug)
Group D (duloxetine)
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
干预措施: Duloxetine (Drug)
结局指标
主要结局
Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
时间窗: up to 2 days.
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
次要结局
- Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).(up to 2 days.)
研究者
antonio bedin
MD
Serviço de Anestesiologia de Joinville