Comparison of Plasma Concentration And Efficacy Of Liposomal Bupivacaine And Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma concentration of bupivacaine
研究概览
简要总结
The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries.
The specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg/kg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg.
The hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng/mL (2-3 mg/L) at which central nervous system and cardiovascular adverse events would be expected to occur.
The secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine.
Additionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation.
Significance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery.
Based on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial catheters and risks associated with them.
详细描述
Liposomal bupivacaine is a relatively new drug formulation. Its safety and side effect profile after intercostal injection has not been extensively studied. Most of the data comes from studies where the medicine was used for wound infiltrations and peripheral nerve blocks for orthopedic surgeries, or from preclinical volunteer studies. PK profile of Exparel varies significantly with different blocks and administration techniques. Very few data are available about pharmacokinetics of the drug after intercostal injections.
Because Exparel contains plain bupivacaine in a liposomal form, it allows for a slower release of the medication from the injection site into the blood stream, and prolongs the duration of action of this local anesthetic. During intercostal infiltration, a local anesthetic is injected into a highly vascular area with increased rate of intravascular absorption and potential risk of toxicity.
Also, because liposomal formulation provides a slow release of local anesthetic, the maximum recommended dose of Exparel (266mg) for intercostal injections is higher than a maximum recommended dose for plain bupivacaine (150mg), which can theoretically increase the risk of local anesthetic toxicity.
The plan of this s to analyze a pharmacokinetic profile and safety of liposomal bupivacaine compared with plain bupivacaine HCl. it is understood that absolute numbers can differ because the doses of the two formulations are different. Unfortunately, the dose of plain bupivacaine cannot be increased to match the dose of Exparel because of the risk of toxicity. The dose of Exparel should not be lowered, because lower doses have been shown to be less effective and are not clinically used at Hershey Medical Center.
Based on prior experience, it is known that prolonged analgesia after Exparel injection is safe, and can help reduce perioperative opioid consumption and decrease opioid related complications.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:
- •VATS wedge resection /segmentectomy
- •VATS lobectomy.
- •Robot assisted thoracoscopic wedge resection/segmentectomy.
- •Robot assisted thoracoscopic lobectomy procedures.
排除标准
- •Patients under18 years of age
- •Patients weighing less than 48 kg
- •Pregnant and lactating females will be excluded from the trial
- •Patients preoperatively taking narcotics for chronic pain in proximity to surgical site
- •Patients with previous ipsilateral thoracic surgery
- •Patients undergoing pleurectomy/mechanical pleurodesis.
- •Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon
- •Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy)
- •Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status
- •Patients with hypersensitivity to local anesthetics and pain medications used in the study
- •Patients with previous thoracic spine surgeries
- •Patients with increased creatinine (over 1.5mg/dl)
- •Patients with liver dysfunction
- •Non-English speaking patients
研究组 & 干预措施
Exparel
Intercostal injection of 266mg of Exparel diluted to 30 ml.
干预措施: Exparel (Drug)
Bupivacaine
Intercostal injection of 0.5% Bupivacaine 2 mg/kg dose diluted to 30 ml.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Plasma concentration of bupivacaine
时间窗: 0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections.
The primary end points to be measured in the study are plasma concentrations of bupivacaine 0.5, 1, 2, 4, 8, 12, 24, 32, 48 hours after intraoperative multiple level intercostal injections of plain Bupivacaine or Exparel. If the patient remains in the hospital, additional samples will be collected at 72 hours. If the patient gets discharged before this time, the last sample will be drawn at time of discharge from the hospital.
次要结局
未报告次要终点
研究者
Zoulfira Nisnevitch-Savarese
Assistant Professor of Anesthesiology & Perioperative Medicine
Milton S. Hershey Medical Center