Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of opiates (morphinequivalent) consumed
研究概览
简要总结
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
详细描述
Bernese periacetabular osteotomy (PAO) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation.
Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement.
It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day) to a control group (placebo) (3ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction.
A double-blinded prospective randomized control trial including up to 60 patients receiving elective unilateral PAO will be conducted.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Only the investigators as well as the head of anasthesiology will be informed.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •General anasthesia
- •Elective periacetabular osteotomy for any reason
- •Written informed consent as documented by signature (Appendix Informed Consent Form)
- •Competent German language skills
排除标准
- •Chronic pain patient, chronic lower back pain
- •Steroid or immunosuppressive drugs used within 6 months of surgery
- •Renal failure, hepatic failure
- •Relevant allergies
- •Pregnancy/ Breast feeding
- •Contraindications for Fortecortin treatment according to Swissmedic
- •Previous enrollment into the current study
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Known or suspected non-compliance, drug or alcohol abuse Illness according to "Warnings and Precautions of Dexamethasone and NaCl"
研究组 & 干预措施
Placebo/ Control group
The patients will not receive any additional drugs preoperatively. 3ml of a 0.9% NaCl Solution (NaCl B. Braun Inf Lös 0.9 % 250ml Ecoflac plus®) will be administered at approx. 8.00 a.m. on the first postoperative day by the investigators.
干预措施: NaCl 0.9% (Drug)
Dexamethasone group
The patients in the dexamethasone group will receive 12mg dexamethasone (Fortecortin ®) intravenously 15-60 minutes prior to surgery while in general anasthesia as well as 12mg dexamethasone intravenously (Fortecortin®) on the first postoperative day at approx. 8.00a.m. by the investigators.
干预措施: Dexamethasone 4 Mg/mL Injectable Solution (Drug)
结局指标
主要结局
Amount of opiates (morphinequivalent) consumed
时间窗: 48 hours postoperatively
The authors will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.
Postoperative pain level
时间窗: 24 hours postoperatively
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain).
Amount of anti-emetics consumed (Ondansetron)
时间窗: 48 hours postoperatively
The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.
次要结局
- Physical therapy milestones 3(1 week postoperatively)
- Physical therapy milestones 2(1 week postoperatively)
- Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire(48 hours postoperatively)
- Number of vomiting events(48 hours postoperatively)
- Length of hospitalization(2 weeks)
- Physical therapy milestones 1(1 week postoperatively)