Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The cumulative opioid consumption
研究概览
简要总结
Patients often experience moderate to severe postoperative pain, especially during the first hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al. 2005), but the analgesic effect can be limited and undesirable side effects may occur.
A case report described that right thoracic paravertebral block reduced pain and analgesic requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural analgesia, thoracic paravertebral block probably carries a much lower risk of spinal haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist 1998; Karmakar 2001).
We therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with sufentanil.
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
- Triple (Participant, Investigator, 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 right lobe hepatectomy
- •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
Placebo PVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
干预措施: Continuous Paravertebral Block with Saline (Procedure)
PVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
干预措施: Continuous Paravertebral block with ropivacaine (Procedure)
PVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
干预措施: Patient-controlled analgesia with sufentanil (Procedure)
Placebo PVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
干预措施: Patient-controlled analgesia with sufentanil (Procedure)
结局指标
主要结局
The cumulative opioid consumption
时间窗: At 24 postoperative hours
次要结局
- The pain scores determined by the numeric rating scale (NRS, 0-10)(At 1, 4, 8, 16, and 24 hrs after the surgery)
- Incidence of postoperative nausea and vomiting(Up to 24 postoperative hrs)
- Incidence of postoperative respiratory depression(Up to 24 postoperative hrs)
- Intraoperative bleeding(Up to 4 hours)
- Postoperative hospital length of stay(Up to 6 weeks)
研究者
Wei Mei
Associate Prof.
Huazhong University of Science and Technology