High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Periacetabular (GANZ) Osteotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Participants With Moderate to Severe Postoperative Pain
研究概览
简要总结
The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery.
The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.
详细描述
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
The "Why in PACU?" database shows that 70 % of patients experience moderate to severe pain in the immediate postoperative phase. This is despite a multimodal analgesic regime with preoperative analgesics and local analgesic catheter in the surgical site.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned unilateral periacetabular osteotomy
- •informed signed consent
排除标准
- •Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)
- •ongoing (<30 days) use of immunosuppressive therapy
- •insulin dependent diabetes
- •pregnancy/breastfeeding
- •allergies toward study medication, or medication in the standard treatment
- •surgery cannot be performed
研究组 & 干预措施
Dexamethasone 48 mg
Dexamethasone 48 mg pre-operative, single shot injection
干预措施: Dexamethasone (Drug)
Dexamethasone 8 mg
Dexamethasone 8 mg pre-operative, single shot injection
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants With Moderate to Severe Postoperative Pain
时间窗: 12 hours
Moderate to severe pain (NRS \> 3) in the post-anesthesia care unit (PACU)
次要结局
- Lenght of Stay, PACU(24 hours)
- Lenght of Stay, Hospital(1 week)
- Pain Scores, PACU(12 hours)
- Number of Patients Readmitted to Hospital Within 30 Days(30 days)
- Complications(24 hours)
- Number of Patients With Sleep Problems(4 days)
- Self Reported Postoperative Pain(postoperative day 0 to 4, once a day)
- Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4(postoperative day 0 to 4, once a day)
- Number of Patients With Feelings of Anxiety, Unrest and/or Sadness(postoperative day 0 to 4, once a day)
- Number of Patients With Wound Infections Within 30 Days(30 days)
研究者
Kristin Julia Steinthorsdottir
MD, clinical assistant
Rigshospitalet, Denmark