Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
研究概览
简要总结
Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
详细描述
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
- •BMI between 18-32.
排除标准
- •Patients who:
- •Are unable to cooperate
- •Has cancer ovarian
- •Does not speak Danish
- •Has allergy for drugs used in the trial
- •Has drug and medicine abuse
- •Diabetes treated with medicine
- •Chronic pain condition
- •Daily use of antacids or analgesic
- •Known kidney disease
- •Use of antidepressive
研究组 & 干预措施
A
干预措施: Pregabalin; Dexamethasone (Drug)
B
Pregabalin
干预措施: Pregabalin; Dexamethasone (Drug)
C
Pregabalin + dexamethasone
干预措施: Pregabalin; Dexamethasone (Drug)
结局指标
主要结局
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
时间窗: 0 - 24h
次要结局
- Pain Score (VAS) at rest and at mobilisation.(0 - 24h)
- Postoperative nausea and vomiting.(0 - 24h)
- Sedation.(0 - 24h)
- Dizziness.(0 - 24h)
- All measurements are taken at 2, 4 and 24 h postoperatively.(0 - 24h)