Phrenic Nerve Infiltration: a Good Practice to Combine Pulmonary Expansion and Pain Control in Patients With High-risk of Prolonged Air Leak
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration
研究概览
简要总结
Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain.
详细描述
This prospective randomized trial received approbation by the institutional review board (Prot. n. 76 SA/2022 RIF. CE 6682/2022) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients.
Patients were defined at risk for PAL in accordance with "2019 Society of Thoracic Surgery score-criteria of PAL". This is an aggregate score specifically designed for lung resection, assigning an odd risk to each patient based on the most common predictors for prolonged air leak including: Body Mass Index <_25.5 kg/m2 (7 points); lobectomy or bilobectomy (6 points); forced expiratory volume in 1 second (FEV1) </= 70% (5 points); male sex (4 points); right upper lobe (3 points). A total score > 17 is considered high risk for PAL.
All patients received pre-operative physical examination, routine blood tests, pulmonary functional test (spirometry and arterial blood gas analysis) and cardiac tests according to the personal clinical history. Imaging collection includes Total Body Computed Tomography (CT) and Positron Emission Tomography (PET). Central tumours required bronchoscopy to assess an eventual endobronchial invasion and to obtain histological diagnosis. If N1/N2 staging was clinically suspected, patients underwent Endo-Bronchial Ultra-Sonography (EBUS) with eventual Trans-Bronchial Needle Aspiration (TBNA) or mediastinoscopy.
Exclusion criteria for the study were: wedge resections, pneumonectomy, neoplasms infiltrating diaphragm and/or chest wall, patients with congenital or acquired neurological diseases, chronic pain, osteo-muscular pathologies affecting the shoulder.
All candidate patients for surgery underwent lung resection with a muscle sparing thoracotomy (lateral 5-6 cm incision on the fifth intercostal space), to reduce bias due by different surgical approaches on the post-operative 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
- None
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 affected by lung cancer eligible for surgery
- •* patients with high risk for post-operative prolonged air leaks: Body Mass Index \<\_25.5 kg/m2 (7 points); lobectomy or bilobectomy (6 points); forced expiratory volume in 1 second (FEV1) \ 17 is considered high risk for PAL
排除标准
- •metastatic desease
- •patients not eligible for surgery because low performance status
- •pneumonectomy/ wedge resections
- •tumors infiltrating phrenic nerve/ diaphragm
- •patients with neurological disorders causing chronic pain
结局指标
主要结局
rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration
时间窗: two years
Rate of pulmonary re-expansion that was defined complete or near complete if lung achieved the 90% of lung surface to the XR; incomplete if lung surface was inferior to 90%. The rate of lung surface is calculated evaluating the "mean interpleural distance": the measurement corresponds to the average of the distances between lung and chest wall calculated at three points (apex, costophrenic sinus, midpoint) in a chest XR; from the average of the three measurements, the rate of lung collapse and the rate of expansion are estimated.
次要结局
- rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic(two years)
研究者
Beatrice Trabalza Marinucci
MD, Principal Investigator
Azienda Ospedaliera "Sant'Andrea"