A Randomized Blinded Controlled Trial of EXPAREL vs 1% Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Global chest pain score
研究概览
简要总结
This phase II trial investigates the effect of EXPAREL compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. This trial aims to see whether EXPAREL or lidocane is able to make patients more comfortable.
详细描述
PRIMARY OBJECTIVE:
I. To compare Global chest pain score (measured on the Visual Analog Scale [VAS] scale) post-procedure and post procedural chest pain (measured on the numerical rating scale), at the time of discharge from recovery between liposomal bupivacaine (EXPAREL) and 1 percent lidocaine.
SECONDARY OBJECTIVES:
I. To compare post procedural chest pain (measured on the numerical rating scale) at the time of discharge from recovery, 24 hours and 48 hours post procedure between EXPAREL and 1 percent lidocaine.
II. To assess the change in global chest pain score (measured on the VAS scale) from baseline to the time of discharge from recovery, and post procedural chest pain (measured on the numerical rating scale) from baseline over time between EXPAREL and 1 percent lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
排除标准
- •Inability to provide informed consent
- •Study subject has any disease or condition that interferes with safe completion of the study including:
- •a. Allergic reaction to EXPAREL
- •Need for pleurodesis
- •Allergies to lidocaine or other local anesthetics.
- •Advanced liver disease where the clinician deems the procedure unsafe
研究组 & 干预措施
Group A (liposomal bupivacaine)
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
干预措施: Liposomal Bupivacaine (Drug)
Group A (liposomal bupivacaine)
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
干预措施: Questionnaire Administration (Other)
Group B (lidocaine)
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
干预措施: Lidocaine (Drug)
Group B (lidocaine)
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Global chest pain score
时间窗: Through study completion, an average of 1 year
Will be evaluated by the Global chest pain score at the time of discharge from recovery area using a Visual Analog Scale 0-100 and represents the pain experienced by the patient.
次要结局
未报告次要终点