Continuous Thoracic Paravertebral Block for Open Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- the postoperative recovery quality on postoperative day 7
研究概览
简要总结
Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.
The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 yrs
- •American Society of Anesthesiologists physical statusⅠ-Ⅲ
- •Undergo hepatectomy with J-shape subcostal incision
- •Informed consent
排除标准
- •A known allergy to the drugs being used
- •Coagulopathy, on anticoagulants
- •Analgesics intake, history of substance abuse
- •Participating in the investigation of another experimental agent
- •Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
研究组 & 干预措施
CTPVB with saline
Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine
干预措施: Continuous Paravertebral "block" with saline (Procedure)
CTPVB with ropivocaine
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
干预措施: Continuous Paravertebral block with ropivacaine (Procedure)
CTPVB with ropivocaine
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
干预措施: Patient-controlled analgesia with morphine (Drug)
CTPVB with saline
Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine
干预措施: Patient-controlled analgesia with morphine (Drug)
结局指标
主要结局
the postoperative recovery quality on postoperative day 7
时间窗: at the 7th postoperative day
The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) \[2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.\]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
次要结局
- post operative length of stay(Up to 2 weeks)
- time to resumption of bowel movement(Up to 2 weeks after surgery)
- the postoperative recovery quality on postoperative day 3(at the 3th postoperative day)
- The pain scores determined by the numeric rating scale (NRS, 0-10)(At 8, 24,48 hours after the surgery)
- cumulated morphine consumption(At 8, 24,48 hours after the surgery)
- time to out-of bed activity/ambutation(Up to 2 weeks)
研究者
Cui Xulei
attending physician
Peking Union Medical College Hospital