The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pain 6 hours postoperatively
研究概览
简要总结
The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered:
- Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
- The postoperative use of additional analgesics.
- Inflammatory parameters before and after surgery.
- Time until mobilization.
- Time until discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients having an abdominal hysterectomy on a benign indication.
- •Patients who speak and understand Danish.
- •Patients who can give informed consent.
排除标准
- •Diabetics
- •Regular use of glucocorticoids, opioids or tranquilizers
- •Regular treatment with immunosuppressives
- •Alcohol or drug abuse
- •Morphine intolerance
- •Age under 18
- •Chronic pain disease eg fibromyalgia, rheumatoid arthritis
- •Malign indication for hysterectomy
- •BMI over 35
- •Decreased kidney function
- •ASA III or IV
研究组 & 干预措施
Methylprednisolone
干预措施: Methylprednisolone 125mg (Drug)
placebo/sodium chloride
干预措施: Sodium Chloride 2 ml (Drug)
结局指标
主要结局
Pain 6 hours postoperatively
时间窗: 6 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
Pain 3 hours postoperatively
时间窗: 3 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
Pain 24 hours postoperatively
时间窗: 24 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
Pain
时间窗: 2-7 days postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
次要结局
- Use of additional analgesics(0-2 days)
- Postoperative nausea(until 2 days postoperatively)
- Use of antiemetics(0-2 days postoperatively)
- Time until mobilization(0-2 days)
- Time until discharge after surgery(0-10 days)
- Inflammatory parameters(0-24 h preoperatively)
- Adverse effects(0-2 days)
- Inflammatory parameter(1-2 days postoperative)
研究者
Anna Aabakke
Anna Aabakke, M.D.
Holbaek Sygehus