The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
研究概览
简要总结
Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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
The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for primary total hip replacement,
- •Between 55 and 85 years of age,
- •ASA 1-3 and BMI between 18 and 35.
排除标准
- •Patients who are:
- •Unable to cooperate
- •Does not speak Danish
- •Has allergy for drugs used in the trial
- •Drug or alcohol abuse
- •Medically treated diabetes
- •Known kidney disease
- •Daily use of analgetics
- •Apart from NSAID
- •Paracetamol or COX2 inhibitors
- •Are treated with a antidepressive.
研究组 & 干预措施
1
干预措施: Gabapentin + dexamethasone + ketamine (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a 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)
- Dizziness(0-24h)
- Sedation(0-24h)
- Nightmare and hallucinations.(0-24h)
- All measurements are taken at 2,4 and 24 h postoperatively.(0-24h)