Erector Spinae Blocks for Thoracic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Outcome Measure - Pain Score and Pain Medications (6 hours)
研究概览
简要总结
The aim of this study is to determine if erector spinae injections with bolus infusions with local anesthetic decrease postsurgical pain and opioid consumption in patients undergoing pulmonary resection surgery.
详细描述
The research hypothesis for the ESB Thoracic study is that erector spinae blocks with boluses of bupivacaine infusions will decrease patients' postsurgical pain, and thereby decrease the amount of narcotic pain medication used. This will be of particular use in patients who have an anticoagulation need and are not able to receive more invasive nerve blocks.To achieve appropriate exposure for pulmonary resection surgery, whether open or video-assisted, patients have surgical incision in the lateral thoracic region, including disruption to the tributaries of the spinal nerves. Due to this dissection, patients frequently experience significant pain post-operatively. Erector spinae blocks with bupivacaine or ropivacaine with bolus infusion therapy have been shown to treat this spinal nerve pain effectively in rib fractures, thoracoscopic surgeries, and breast surgeries. However, there have been no definitive studies evaluating the effectiveness of erector spinae blocks in postoperative pulmonary resection surgery patients.
It is expected that patients with erector spinae blocks (ESB) will have lower pain visual analogue scores (VAS) and lower total opioid consumption. Learning more about the effectiveness of ESB can help in providing adjunct therapy and thereby minimize post-operative opioids, use of which can add further complications in this group of patients through decreased ventilation and increased atelectasis and hypercarbia. As well, current neuraxial local anesthetic therapy involving epidurals and paravertebral blocks require an absence of anticoagulation in the patient; as a fascial plane block, erector spinae blocks can be safely placed in patients on anticoagulation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pulmonary resection
- •18<age<90
排除标准
- •pleurodesis
- •decortication
- •emergent surgery
- •local anesthetic allergy
- •intraoperative complication (inadvertent hemorrhage or conversion to open surgery)
- •bilateral pulmonary resection
研究组 & 干预措施
Standard of Care + ESB Thoracic
Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment
干预措施: ESB Thoracic (Drug)
Standard of Care
Patients randomized to this group will receive standard of care treatment and NO erector spinae block
结局指标
主要结局
Outcome Measure - Pain Score and Pain Medications (6 hours)
时间窗: At 6 hours postoperatively
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 6 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Outcome Measure - Pain Score and Pain Medications (24 hours)
时间窗: At 24 hours postoperatively
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 24 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Outcome Measure - Pain Score and Pain Medications (12 hours)
时间窗: At 12 hours postoperatively
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 12 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
次要结局
未报告次要终点