Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- tissue oxygenation
研究概览
简要总结
The primary objective is to evaluate the influence of continuous local anesthetic infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a major predictor for wound healing.
详细描述
Patients undergoing abdominal surgery will be randomized to one of two groups.
Group 1: Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Group 2: Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
All patients will be premedicated with IV midazolam up to 5 mg. On arrival to the operating room, a fluid bolus of 10 ml/kg/h will be administered before induction of anesthesia.
Those randomized to local wound perfusion will receive the local anesthetic or placebo via the ON-Q pain management system. At the end of surgery a catheter will be positioned in the subcutaneous layer of the wound, leaving via a separate stab incision. The wound closure will then be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age.
- •The patient has provided written informed consent.
- •The patient is scheduled for abdominal surgery.
- •The patient has an ASA of I, II, or III.
- •The patient understands the explanation of the protocol.
排除标准
- •Patients aged < 18 and > 80 years.
- •History of diabetes mellitus.
- •History of congestive heart failure.
- •History of peripheral vascular disease.
- •History of smoking.
- •History of Dysautonomia.
- •History of thyroid disease.
- •Susceptibility to malignant hyperthermia.
- •History of morbid obesity.
- •History of fever
- •History of infection.
- •Contraindication to the placement of an arterial line; e.g., Raynaud's disease.
- •The patient declines participation.
- •Any patient the investigator feels is not a candidate for this study.
- •Any patient with a history of known alcohol, analgesic, or narcotic substance abuse within two years of screening.
研究组 & 干预措施
Placebo
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
干预措施: Saline (Drug)
bupivacaine
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
干预措施: Bupivacaine (Drug)
结局指标
主要结局
tissue oxygenation
时间窗: 24 hours post surgery
averge tissue oxygenation on wound healing after abdominal surgery
次要结局
- Verbal rating scales (VRS)(24 hours post surgery)