Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Pain at rest during the first 3 postoperative days on a 11-point NRS
研究概览
简要总结
To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.
详细描述
Patients enrolled are randomized to active substance or placebo approximately 30 minutes prior to skin incision.
Patients are followed for 30 days postoperative with registration of outcomes on a postoperative questionnaire. Patients are contacted by telephone at every registration time. The primary outcome is also secured over the telephone in case patients do not return their questionnaire.
With a power of 80% and a significance level of 5% we need 64 patients (32 in each arm) to show a 30% reduction in postoperative pain during the first 3 postoperative days with 5 measurements and we need 42 patients (21 in each arm) to show a 15% increase in the QoR-15 during the first 3 postoperative days. With an anticipated loss to follow up of 20% we need 80 patients ( 40 in each arm).
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
- •Laparoscopy for suspected appendicitis
- •Age 18 years or older
- •American Society of Anesthesiologist (ASA) class I-III.
- •Gives written and oral consent
排除标准
- •Known inflammatory bowel disease.
- •Known autoimmune disease.
- •Chronic pain patient.
- •Presumed poor compliance.
- •Pregnant or breastfeeding.
- •In systematic treatment with glucocorticoids or other immunosuppressive treatment.
- •Known renal disease, GFR<
- •Known liver cirrhosis.
- •Known heart failure, EF<40%.
- •Known glaucoma.
- •Known ocular herpes simplex.
- •Known cushings disease.
研究组 & 干预措施
Methylprednisolone
125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision
干预措施: Methylprednisolone (Drug)
Placebo
0.9% Saline intravenously approximately 30 minutes prior to skin incision
干预措施: 0.9% Saline (Drug)
结局指标
主要结局
Pain at rest during the first 3 postoperative days on a 11-point NRS
时间窗: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Powered to detect 30% reduction, Random regression model (mixed effects model)
次要结局
- Sleep during the first 3 postoperative days on a 11-point NRS(postoperative day (POD) 1, POD2 and POD3)
- Incidence of postoperative nausea or vomiting during the first postoperative day(6 hours, 12 hours and 24-32 hours postoperative)
- Pain at rest after POD3 on a 11-point NRS(postoperative day (POD) 7, POD 14 and POD 30)
- Fatigue during the first 3 postoperative days on a 11-point NRS(6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3)
- QoR-15 during the first 3 postoperative days(postoperative day (POD) 1, POD2 and POD3)
- Pain when coughing during the first 3 postoperative days on a 11-point NRS(6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3)
- Pain when coughing after POD3 on a 11-point NRS(postoperative day (POD) 7, POD 14 and POD 30)
- Fatigue after POD3 on a 11-point NRS(postoperative day (POD) 7, POD 14 and POD 30)
- QoR-15 after POD 3(postoperative day (POD) 7, POD 14 and POD 30)
- Mobilization during the first postoperative day on a 4-point likert scale(6 hours, 12 hours and postoperative day 1)
- Resumption of occupational activity(Up to 60 days postoperative)
- Resumption of recreational activity(Up to 60 days postoperative)
- Duration of convalescence(Up to 60 days postoperative)
- Adverse events according to GCP guidelines(30 day postoperative)
- Postoperative complications according to the Clavien-Dindo classification(30 day postoperative)
- Opioid consumption during the first 24 hours postoperative(24 hours postoperative)
- Need for rescue antiemetics during the first 24 hours postoperative(24 hours postoperative)
- Duration of postoperative hospital stay(30 days postoperative)
- Sleep after POD3 on a 11-point NRS(postoperative day (POD) 7, POD 14 and POD 30)
研究者
Jakob Kleif
MD
Nordsjaellands Hospital