Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
Postoperative pain after thoracic surgery is associated with adverse outcomes. The current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption.
The investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after VATS in a randomized study.
详细描述
Inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (PPC), and chronic post surgical pain.
Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control.
Thoracic paravertebral block (TPVB) has been introduced as an effective method in postoperative pain management after VATS. It is associated with improved pain control and the reduction of opioid analgesic consumption in several studies.
The use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy.
The aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after VATS.
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
- •American Society of Anesthesiologist physical status 1-3
- •Scheduled for elective video-assisted thoracic surgery
- •Able to operate a patient-controlled analgesia device (PCA)
排除标准
- •History of morphine allergy
- •History of bupivacaine allergy
- •Contraindication for ketamine infusion
- •Contraindication for thoracic paravertebral block
- •Anticipated postoperative positive pressure ventilation
- •Body mass index more than 35
- •Any known psychiatric disorder
研究组 & 干预措施
Ketamine
Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
干预措施: Ketamine (Drug)
Normal saline
Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: 24 hours postoperatively
Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
次要结局
- Time to first analgesia(24 hours postoperatively)
- Peak flow rates (day 1)(1 days)
- Peak flow rates (day 2)(2 days)
- Chronic post-surgical pain(3 months)
研究者
Sirilak Suksompong
Associate Professor
Mahidol University