A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
研究概览
简要总结
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
详细描述
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •All patients over 18 years of age
- •Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
排除标准
- •Previous ipsilateral thoracic surgery
- •Need for operative pleurectomy or pleurodesis
- •Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
- •Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- •Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
- •Renal dysfunction (eGFR < 60ml/min/1.73m2)
- •History of peptic ulcerative disease
- •Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
- •Inability to consent
- •Pregnancy
- •Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
- •Patient is discharged from the hospital with a chest tube in place
- •Patient fails to comply with post-operative instructions
研究组 & 干预措施
Exparel
Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
干预措施: Liposomal Bupivicaine (Drug)
0.25% standard bupivicaine
Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
干预措施: 0.25% standard bupivicaine (Drug)
结局指标
主要结局
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
时间窗: Assessed daily for 7 days post-procedure
Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.
次要结局
- Number of Patients With Paresthesias (Postoperatively at 7 Days)(Assessed at day 7 post-procedure)
- Scores on a Analog Pain Scale (7 Days)(Assessed at day 7 post-procedure)
- Return to Baseline Activity(Assessed at 30 days post-procedure)
- Return to Work(Assessed at 30 days post-procedure)
- Days Until Return to Work(Assessed at 30 days post-procedure)
- Proportion of Patients With Paresthesias (Postoperatively at 30 Days)(Assessed at day 30 post-procedure)
- Hospital Length of Stay(From end of procedure until discharge, usually 0-2 days.)
- Scores on an Analog Pain Scale (30 Days)(Assessed at 30 days post-procedure)
- Overall Hospital Cost(Total cost assessed from patient registration until discharge to home (usually 0-2 days).)