Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Local Anesthetic Consumption
研究概览
简要总结
Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural anesthesia (PCEA) is more effective but little research has compared the two methods following thoracotomy. The current randomized, prospective clinical investigation did just this. Following institutional ethics approval 52 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively all patients were titrated on continuous epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined randomization (either remained on continuous epidural infusion or they were switched to receive 2/3 of the stabilized background dose via continuous epidural infusion with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •American Society of Anesthesiologist's (ASA) Physical Status I-III
- •Body Mass Index (BMI) < 40
- •Able to use a PCEA device
排除标准
- •Intolerance/hypersensitivity to agents used in the study
- •Contraindication to epidural placement
- •Current alcohol/substance abuse
- •Chronic pain condition requiring chronic analgesic
- •BMI ≥ 40 or body weight less than 50kg.
研究组 & 干预措施
Patient controlled epidural analgesia
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
干预措施: Patient controlled epidural analgesia (Procedure)
continuous epidural analgesia
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion rate until stable pain scores of ≤ 3 were reached while in PACU (as described in the PCEA group). Once stable, they were allocated to their preoperatively determined randomization assignment which for the CEA group meant they remained on the continuous background epidural infusion rate previously determined to maintain pain scores ≤ 3 while in PACU. Rescue analgesia was available as needed.
干预措施: Continuous epidural analgesia (Procedure)
结局指标
主要结局
Local Anesthetic Consumption
时间窗: 48 hours postoperatively
Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.
Anesthetic Consumption (mg)
时间窗: 4,8,12, 24 and 48 hours postoperatively
amount of anesthetic consumed was calculated for each group over time.
次要结局
- Worst Pain While Coughing(48 hours postoperatively)
- Worst Pain Scores(48 hours postoperatively)
研究者
Dr. Vidur Shyam
Principal Investigator
Queen's University