2025-520891-25-00招募中2 期
High Dose Dexamethasone in High-Pain-Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy – A Randomized Double-Blinded Controlled Trial
适应症
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 on POD1 (Numeric Rating Scale 0-10)
研究概览
简要总结
The aim is to conduct a randomized controlled trial 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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Able to understand written and spoken Danish language
- •Pain Catastrophizing Scale ≥ 20
- •Patient planned to elective Video-Assisted Thoracoscopic Surgery Lobectomy/Segmentectomy
排除标准
- •Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, excluding inhaled steroids.
- •Individuals undergoing conversion to a surgical procedure other than VATS lobectomy/segmentectomy.
- •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 spinal cord or brain injuries, severe polyneuropathies, or neurological disorders
- •Regular users of opioid medications.
- •Patients requiring reoperation within the first two postoperative days
结局指标
主要结局
Pain when coughing on the morning on POD1 (Numeric Rating Scale 0-10)
Pain when coughing on the morning on POD1 (Numeric Rating Scale 0-10)
次要结局
- Pain at 5-meter walk test in the morning and afternoon POD1+2 (NRS)
- Pain when coughing on the afternoon POD1 + morning and afternoon POD2 (NRS)
- Postoperative length of stay (in days)
- Cumulative use of rescue analgesics per day during POD1+2
- Cumulative use of rescue antiemetics per day during POD1+2
- Reasons for re-admission within 30 days (defined as overnight hospital stay after discharge)
- Intensive Care Unit Days
- Pain Catastrophizing Scale (PCS)
- Morbidity and mortality (30-day)
- Quality of recovery questionnaire (QoR15) in day 7
- Nausea (NRS)
- Episodes of vomiting
研究者
Lasse Visby
Scientific
Rigshospitalet
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Prevention of Rebound Pain After Axillary BlockNCT07313553University Tunis El Manar60
进行中（未招募）
不适用
Dexamethasone as pain treatment after shoulder surgery.Pain following arthroscopic shoulder surgery.MedDRA version: 14.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10040617Term: Shoulder painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-003082-15-DKKaren Toftdahl Bjørnholdt75
招募中
2 期
High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /SegmentectomyNCT07213375Rigshospitalet, Denmark80
已完成
不适用
Dexamethasone Versus Prednisolone in Acute Exacerbation of Childhood AsthmaNCT07275593Muhammad Aamir Latif224
已完成
4 期
High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative PainPostoperative PainPostoperative Nausea and VomitingPerioperative/Postoperative ComplicationsSurgeryOpioid UseCatastrophizing PainChronic PainHip OsteoarthritisNCT03763760Copenhagen University Hospital, Hvidovre160