Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Postoperative functional recovery
研究概览
简要总结
This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.
Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).
Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.
Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.
详细描述
This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective open colon surgery
排除标准
- •ASA physical status 4
- •history of:
- •hepatic failure (liver enzymes abnormally elevated)
- •renal failure (creatinine over 150 mmol/L)
- •cardiac failure
- •organ transplant
- •morbid obesity (BMI > 40 kg/m-2)
- •chronic use of opioids
- •allergy to local anaesthetics
- •History of seizure
- •contraindications to the insertion of epidural
- •INR > 1.3, PTT > 44 second, platelets < 150.000 per microliter,
- •previous spinal surgery limiting the insertion)
- •inability to comprehend pain assessment
结局指标
主要结局
Postoperative functional recovery
时间窗: at 24, 48, 72 hours, 4 and 8 weeks after the surgery
次要结局
- postoperative pain(at 24, 48, 72 hours after the surgery)
- opioid consumption(at 24, 48, 72 hours after the surgery)
- opioid side effects(at 24, 48, 72 hours after the surgery)
- return of bowel function(at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.)
- length of hospital stay(at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.)
研究者
Franco Carli
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre