High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain when coughing on the morning of first postoperative day.
研究概览
简要总结
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy.
The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in the morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
详细描述
Annually, approximately 400 anatomical resections (lobectomy and segmentectomy) are performed using video-assisted thoracoscopic surgery (VATS) at the Department of Cardiothoracic Surgery, Rigshospitalet.
Tissue damage occurs during surgery, triggering an inflammatory response.Glucocorticoids, including Dexamethasone, administered in relation to surgery, have shown anti-inflammatory effects in previous studies and the potential to reduce postoperative pain and hospitalization duration in various surgical procedures.
Previous studies have indicated that the most common complications of VATS lobectomy leading to prolonged hospitalization in patients are air leakage (27%), pneumonia (20%), and pain (15%).
A previous study from Rigshospitalet, Denmark found that half of the patients undergoing a VATS lobectomy, reported severe pain (defined as Numeric Rating Scale (NRS) ≥ 5) at some point on the day of surgery and first postoperative day. This indicates a need for better pain management following VATS lobectomy, which is confirmed by another study Rigshospitalet, Denmark that found a high rate of severe pain (NRS > 5) in the first two days after a VATS lobectomy. The median NRS score when coughing on the morning after surgery was 6.0 (5.0-8.0). Improved pain management is expected to facilitate easier mobilization, likely resulting in fewer pulmonary complications and shorter hospital stays.
The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire examining catastrophic thinking in relation to pain. The PCS score has previously been shown to correlate with postoperative pain, and in another study found that increasing scores of PCS resulted in higher pain scores, and that patients grouped as "High-pain-responders" (PCS≥20) had significantly more pain when coughing on the first postoperative day.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 year
- •Able to understand written and spoken Danish language
- •Signed written informed consent form.
- •Patient planned to elective VATS lobectomy/segmentectomy
排除标准
- •Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, ex-cluding inhaled steroids.
- •Individuals with diabetes requiring insulin treatment.
- •Pregnant or breastfeeding patients.
- •Patients with known allergies to the study drug.
- •Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.
- •Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications.
- •Individuals with altered pain perception due to other conditions or injuries, such as spi-nal cord or brain injuries, severe polyneuropathies, or neurological disorders.
- •Regular users of opioid medications.
- •Patients requiring reoperation within the first two postoperative days.
- •Individuals undergoing conversion to a surgical procedure other than VATS lobecto-my/segmentectomy.
研究组 & 干预措施
Low dose Dexamethasone (8mg)
干预措施: Dexamethasone (Drug)
High dose Dexamethasone (1mg/kg)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Pain when coughing on the morning of first postoperative day.
时间窗: Morning of first postoperative day
The primary endpoint is pain when coughing on the first morning after surgery, measured on the NRS-scale (0-10; where 0 is no pain, and 10 is the worst possible pain).
次要结局
未报告次要终点
研究者
Lasse Visby
Co-investigator
Rigshospitalet, Denmark