Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective Video Assisted Thoracic Surgery (VATS): a Single Center, Randomized, Multiple-blinded, Controlled, Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- cumulative dose of opioids at 24 and 48 h
研究概览
简要总结
The aim of the study is to compare two different locoregional techniques in VATS.
详细描述
There are clear clinical and logistic reasons for pursuing the best possible post-operative pain management avoiding the negative side effects of opioid treatment; in order to garantee an enhanced recovery after surgery. A short hospital stay is fundamental to reduce patient morbidity and costs. Regional anesthetic nerve blocks are an ideal option to achieve this goal.
Paravertebral block serves as an ideal approach for thoracic and abdominal surgery through delivering segmental anesthesia of operative sites. Thoracic paravertebral block has superior analgesia as well as fewer complications than systemic opioids. It has been successfully applied in sternotomy, breast surgery, abdominoplasty, and laparoscopic cholecystectomy. ESP block is a recently described technique, with promising results in different scenarios. It probabily has a better risk profile than PVB, for its lower possibility of accidental pleural puncture and reabsorption of local anesthtetic than PVB one
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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 over 18 year of age undergoing elective VATS lung resection at ORBV
排除标准
- •patients with inability to consent, contraindications to standard care, or factors that can cause bias in interpretation, absolute contraindications to the regional anesthesia techniques studied (patient's refusal, allergy to local anesthetics, infections in the site of injection). Pregnant women are not a target study-group so they are excluded for design simplification. Conversion to the open technique will be a post-randomization exclusion factor concerning the main outcomes
研究组 & 干预措施
US-guided ESP block + sham US-guided TPV block
ESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution
干预措施: ESP block (Procedure)
sham US-guided ESP block + US-guided TPV block
ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic
干预措施: ESP block (Procedure)
结局指标
主要结局
cumulative dose of opioids at 24 and 48 h
时间窗: 48 hours
by using a PCA we will see how many times the patient asked for analgesia
次要结局
- Episodes of urinary retention(48 hours)
- Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough(48 hours)
- Hypotension(48 hours)
- Procedure time and complications(48 hours)
- Need for anti-nausea medication (dosage, doses and time points)(48 hours)
- Episodes of vomiting(48 hours)
- Length of hospital stay(48 hours)
- Cardio-pulmonary complications(48 hours)
- Need for epidural catheter(48 hours)
研究者
Andrea Saporito
Head of Anesthesiology, PD DR MED
Ente Ospedaliero Cantonale, Bellinzona