Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of analgesic effect
研究概览
简要总结
To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.
详细描述
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.
At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.
The aim of this study is to examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.
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, 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
- •Adults independent of sex with an age of ≥ 18 years
- •Patients undergoing VATS as a part of either examination or treatment of lung cancer
排除标准
- •Patients who are unable to understand oral and written information.
- •Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
- •Pregnant and nursing women.
- •Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine.
- •Patients receiving a planned preoperative epidural blockade during their stay.
- •Patients converted to open surgery.
研究组 & 干预措施
Control
Bupivacaine Hydrochloride in perioperative intercostal blockades
干预措施: Bupivacaine Hydrochloride (Drug)
Intervention
Liposomal bupivacaine in perioperative intercostal blockades
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Duration of analgesic effect
时间窗: 48 hours
Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
次要结局
- Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish(Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months))
- Numerical Rating Scale(48 hours)
- Total equipotent opioid dose(48 hours)
- Mobilisation(48 hours)
- Opioids at discharge(Not fixed. On average 4 days and a maximum of 3 months.)
研究者
Jannie Bisgaard Stæhr
Principal Investigator
Aalborg University Hospital