Comparison of Thoracic Epidural and Intravenous Analgesia From the Perspective of Recovery of Respiratory Function at Early Post-thoracotomy Period in Lung Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Postoperative FEV1 and FVC alterations
研究概览
简要总结
Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded
详细描述
lung cancer patients (between ages 18 to 75 and American Society of Anesthesiologists -ASA- Class I to III), undergoing an elective thoracic surgical procedure with posterolateral thoracotomy, were enrolled. The study was approved by the local ethical committee in Yedikule Chest Diseases and Thoracic Surgery Ed. and Research Hospital and therefore had been performed in accordance with global ethical standards. Written informed consent was received from all participants.
Individuals beyond defined age limits, patients who have psychiatric problems, auditory deficit, drug abuse, severe cardiovascular system disorders or severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume were excluded. Patients refusing to give consent and to whom inserting an epidural catheter is contraindicated were not involved either. Surgical procedures were performed by the same team. In the operating room, if serratus anterior muscle could not be spared or chest wall resection was performed, these patients were also excluded even though they had met other qualifications. Finally, patients who could not be extubated before transfer were not involved.
Regarding pre-operative evaluation, age, gender, weight, height, smoking status (package/years) and ASA score of patients were recorded.
For assessing the impact of method of analgesia on target parameters, patients were allocated to TEA and intravenous analgesia (IVA) groups. Randomisation was performed by closed envelope method.
2.2 Features of anesthetic technique and intraoperative analgesia Before the initiation of procedure, in TEA group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of a 18 G Thuohy needle (Pajunk, Geisingen, Germany) while patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintanence was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists -ASA- Class I to III)
- •Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy
排除标准
- •Individuals beyond defined age limits
- •Having psychiatric problems
- •Having an auditory deficit
- •Active drug abuse
- •Severe cardiovascular system disorders
- •Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
- •Refusing to give consent
- •Contraindication to insertion of an epidural catheter.
研究组 & 干预措施
Thoracic Epidural Analgesia
Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.
干预措施: Thoracic epidural analgesia (Procedure)
Thoracic Epidural Analgesia
Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.
干预措施: Bupivacaine (Drug)
Intravenous analgesia
Population to whom combined intravenous analgesia was administered.
干预措施: Thoracic epidural analgesia (Procedure)
结局指标
主要结局
Postoperative FEV1 and FVC alterations
时间窗: 3 days
Comparison of preoperative and postoperative FEV1 (liters, %) and FVC.(liters, %)
次要结局
- Postoperative pO2 alteration(24 hours)
- Postoperative pH alteration(24 hours)
- Postoperative pCO2 alteration(24 hours)
- Postoperative HCO3 concentration alteration(24 hours)
研究者
Derya Ozden Omaygenc
Principal investigator
Yedikule Training and Research Hospital
