Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Morphine Consumption
研究概览
简要总结
Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative.
The study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgery of hepatic resection by first under costal.
- •Patient classified ASA 1 to
- •Information, signed and informed consent
排除标准
- •Patients classified ASA 4 or
- •Allergy or intolerance to any of the products used in the protocol.
- •Emergency surgery, palliative surgery, surgical recovery.
- •History of chronic pain requiring the regular use of analgesics, especially opioids.
- •History of drug misuse.
- •Inability to understand and / or use the patient's self-controlled morphine pump.
- •Known history of psychiatric disorders or current psychotropic treatment (excluding benzodiazepine monotherapy)
- •Additive behavior with respect to alcohol or non-weaned psychodysleptic substances
- •Pregnant Woman or Breastfeeding
研究组 & 干预措施
intrathecal morphine
Rachianalgesia + PCA morphine
干预措施: Morphine PCA (Drug)
Ropivacaine infiltration
Continuous infiltration of local anesthetics + PCA morphine.
干预措施: intrathecal morphine (Drug)
Ropivacaine infiltration
Continuous infiltration of local anesthetics + PCA morphine.
干预措施: Morphine PCA (Drug)
intrathecal morphine
Rachianalgesia + PCA morphine
干预措施: Ropivacaine infiltration (Drug)
morphine PCA
PCA morphine alone
干预措施: Morphine PCA (Drug)
结局指标
主要结局
Morphine Consumption
时间窗: During the first 24 hours post operative
Morphine consumption is measured all 3 hours during the first 24 hours post operative
次要结局
- Morphine Consumption(During the 48 hours post operative)
- Evaluation of postoperative pain intensity after activity(All 3 hours during the 48 postoperative hours)
- Electric nociception threshold measured by PainMatcher(At 48 hours post operative)
- Evaluation of postoperative pain intensity at rest(All 3 hours during the 48 postoperative hours)
- Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)(At 6 months after surgery)
- Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)(At 3 months after surgery)
- Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),(At 6 months after surgery)
- Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),(At 6 months after surgery)
- Area peri-incisional hyperalgesia(At 48 hours post operative)
- Number of nausea and/or vomiting episodes(At 72 hours after surgery)
- Number of patient with side effect of morphine consumption(Up to 72 hours after surgery)
- Time physiological function recovery(Up to the end of hospital stay, an average 10 days)
- Length of hospital stay in intensive care unit(Up to the end of hospital stay,an average 10 days)
- Length of hospital stay(Up to the end of hospital stay , an average 10 days)