Pain Control After VATS Anatomical Pulmonary Resections: Randomized Comparison Between Cryoanalgesia, Erector Spinae Plane Block and Epidural Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.
In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.
Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.
The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.
详细描述
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.
In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.
Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.
The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.
All patients undergoing anatomical pulmonary resections (lobectomy or segmentectomy) through a thoracoscopic (VATS) approach, and who present the inclusion/exclusion characteristics, will be considered.
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
- •all patients undergoing VATS anatomic pulmonary resection (lobectomy or segmentectomy) for benign or malignant disease
排除标准
- •Refusal or inability to give informed consent to the study protocol
- •Age < 18 years
- •Pregnancy
- •Allergies or contraindications to any of the treatments considered in the experimental design
- •Pre-operative use of pain medication for chronic pain or neuropathic pain
- •History of previous major chest surgery
- •American Society of Anesthesiologists (ASA) class > 3
- •Need for intensive care unit stay in the post-operative period
- •Patients undergoing anatomical pulmonary resections different than lobectomy or segmentectomy (bi-lobectomy or pneumonectomy).
- •Patients undergoing bronchial and/or vascular resections and reconstructions
研究组 & 干预措施
Epidural
In patients randomized to this Arm, before the induction of general anesthesia, the epidural catheter is placed in the intervertebral space (T4-T5, T5-6 or T6-T7) and used intra and post-operatively for administration of local anesthetics.
干预措施: Epidural (Procedure)
ESP block
In patients randomized to this Arm, after induction of general anesthesia the Erector spinae plane (ESP) block is performed with a catheter introduced and left in place for continuous postoperative infusion of local anesthetics.
干预措施: ESP block (Procedure)
Cryoanalgesia
In patients randomized to this Arm, after induction of general anesthesia and single lung ventilation the first thoracoscopic surgical access is performed. A cryoanesthesia device with a dedicated atraumatic angled-tip cryoprobe is inserted through the thoracoscopic access and the active tip of the probe is positioned in contact with the intercostal nerves from T3 to T8.
干预措施: Cryoanalgesia (Procedure)
结局指标
主要结局
Post-operative pain
时间窗: 24 hours after surgery
Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)
次要结局
- Post-operative pain trend(1,6,12 and 48 hours after surgery)
- Rescue Analgesia(48 hours after surgery)
研究者
Giovanni Maria Comacchio
Thoracic Surgeon
University Hospital Padova