NCT02173418已完成4 期
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Shoulder pain within 6 hours after the operation
研究概览
简要总结
The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.
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
- •Patients planned for elective lobectomy or pneumonectomy
- •18 years or more on the day of the operation
- •Danish skills appropriate for fulfilling preoperative questionnaires
排除标准
- •Known contralateral paresis of the Phrenic nerve
- •Allergy to Ropivacaine or Sodium Chloride
- •Preoperative ipsilateral shoulder pain
- •Infection or eczema on the intervention site. Clinical decision
- •Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
- •Acute porphyria
研究组 & 干预措施
Ropivacaine
Experimental
Phrenic nerve block with Ropivacaine
干预措施: Phrenic nerve block with Ropivacaine (Drug)
Placebo
Placebo Comparator
Phrenic nerve block with Sodium chloride
干预措施: Phrenic nerve block with saline (Drug)
结局指标
主要结局
Shoulder pain within 6 hours after the operation
时间窗: Retrospective numerical rating scale, 6 hours after the operation
Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)
次要结局
- Number of patients with shoulder pain during the first 3 postoperative days.(Postoperative days 0-3)
- NRS for shoulder pain during the first 3 postoperative days.(Postoperative days 0-3)
- Opioid use during the first 3 postoperative days(Postoperative day 0-3)
- Time spent in the recovery room(Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.)
- Shoulder pain 3 months postoperatively(3 months postoperatively)
- NRS for shoulder pain 3 months postoperatively(3 months postoperatively)
- Thoracic pain 3 months postoperatively(3 months postoperatively)
- NRS for thoracic pain 3 months postoperatively(3 months postoperatively)
- opioid use 3 months postoperatively(3 months postoperatively)
- Shoulder function 3 months postoperatively(3 months postoperatively)
研究者
Morten Rune Blichfeldt-Eckhardt
Afdelingslæge
Odense University Hospital
研究点 (1)
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