Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Amount of Opioid Consumption
研究概览
简要总结
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.
Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.
The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.
The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.
详细描述
Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient, surgeon, and anesthesiologist in the case will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anesthesiology) class I-IV
- •age 81-75
排除标准
- •ASA class V
- •morbid obesity
- •patient refusal
- •patients with chronic pain or on pain medications
- •allergy to LA
- •patients receiving any additional regional techniques
- •coagulopathy
- •patients receiving systemic anticoagulation
- •local infection
- •procedures anticipated to last more than 5 hours.
研究组 & 干预措施
Serratus Plane Group
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
干预措施: Bupivacaine (Drug)
Serratus Plane Group
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
干预措施: Bupivacaine liposome (Drug)
Placebo Group
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
Amount of Opioid Consumption
时间窗: up to 24 hours post procedure
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
次要结局
- Time to First Dose of Narcotic Administration(up to 24 hours post procedure)
- PACU Length of Stay(average 3-4 hours post procedure)
- ICU Length of Stay(up to 40 hours post procedure)
- Visual Analogue Score (VAS)(up to 24 hours post procedure)
- Patient Satisfaction Score(up to 24 hours post procedure)
研究者
Yan Lai
Assistant Professor
Icahn School of Medicine at Mount Sinai
