Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Morphine consumption (mg)
研究概览
简要总结
The objective of the study is to compare the efficacy of the Serratus Anterior Plane block (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours, to a standard intravenous analgesia for small videoassisted thoracic surgery interventions. The objective is also to evaluate the resorption rate of local anesthetic at this level, and make a population pharmacokinetic analysis.
详细描述
In this study, 20 patients will be randomly assigned to one of two groups: ten patients will have a Serratus anterior plane block (SPB), with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter located under the serratus anterior muscle, for a duration of 24 hours. The other group will have a standard intravenous analgesia with a PCA morphine-dehydrobenzperidol pump. Anesthesia protocol will be standardized. Except the infusion of ropivacaine for the SPB, per operative anesthesia and post operative analgesia will be the same for every usual patients.
The investigators will evaluate post operative pain based on the visual analog scale, 24 hours morphine consumption, sensitivity of concerned territory. The investigators will also evaluate post operative chronic pain by assessing pain two months post operatively, completing two questionnaires of neuropathic pain: DN4 and QDSA short form.
Finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over 24 hours after realizing the SPB, in order to make a population pharmacokinetic analysis, and evaluate the degree of ropivacaine resorption at this level.
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
- Single (Participant)
盲法说明
Random attribution by computer
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physic status 1, 2 and 3 who require surgical video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy
- •Lung pathologies:
- •symphysis, pleurectomy
- •emphysema bullae resection
- •pleural pathologies:
- •collections, intra pleural effusion
- •mediastinal pathologies:
- •adenopathy staging
- •sympathectomy T2-T5
- •splanchnicectomy
排除标准
- •allergy to local anesthetic - contra-indication to the use of ropivacaine
- •liver failure
- •severe kidney disease (GFR < 15ml/min)
- •chronic intake of opioids
- •neurological or psychiatric disorders interfering with pain assessment
- •severe and morbid obesity (BMI > 35)
结局指标
主要结局
Morphine consumption (mg)
时间窗: 24 hours
Consumption of intravenous morphine
次要结局
- Pain score(24 hours)
- Sensitivity of SPB zone(24 hours)
- Post operative vomiting(24hrs)
- Post operative nausea(24 hours)
- Post operative chronic pain(2 months)
研究者
Paul Gruson
Principal investigator
Université Libre de Bruxelles