Bupivacaine Liposome Suspension Administration to Decreasre Peri-procedural Pain in Interventional Radiology (IR) Procedures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Pain Scores
研究概览
简要总结
This study evaluates the use of liposomal bupivacaine (Exparel), a long-acting local anesthetic, for peri-procedural pain control in patients undergoing interventional radiology (IR) procedures. Effective pain management during and after IR procedures is important for patient comfort, procedural success, and recovery, yet standard local anesthetics (e.g., lidocaine or bupivacaine HCl) provide relatively short durations of analgesia.
Liposomal bupivacaine is an FDA-approved formulation designed to provide extended-release local anesthetic effects over a prolonged period. Its use has been studied in surgical settings, but data in interventional radiology procedures remain limited. This prospective, single-arm quality improvement initiative aims to assess whether incorporation of liposomal bupivacaine into routine procedural care improves patient-reported pain outcomes.
Adult patients undergoing IR procedures will receive liposomal bupivacaine administered by the proceduralist as part of standard care. Pain will be assessed using a structured patient-reported outcome survey at multiple time points, including pre-procedure, during the procedure, 1 hour post-procedure, and within 24 hours post-procedure. The survey also captures use of additional analgesic medications within the first 24 hours.
The primary outcome is patient-reported pain intensity. Secondary outcomes include post-procedural analgesic utilization. Data will be analyzed descriptively given the exploratory nature and small sample size.
Findings from this project may inform future approaches to pain management in interventional radiology and help determine whether longer-acting local anesthetics provide clinically meaningful improvements in patient experience.
详细描述
Background and Rationale
Effective peri-procedural pain control is an important component of interventional radiology (IR) procedures, influencing patient comfort, procedural tolerance, and recovery. Standard local anesthetics such as lidocaine and bupivacaine hydrochloride provide relatively short durations of analgesia, which may not extend sufficiently into the post-procedural period.
Liposomal bupivacaine (Exparel) is an extended-release formulation of bupivacaine designed to provide prolonged local anesthetic effect following a single administration. While this formulation has been studied in surgical settings, its role in minimally invasive interventional radiology procedures is less well defined.
This quality improvement initiative is designed to evaluate whether the use of liposomal bupivacaine during IR procedures improves patient-reported pain outcomes and reduces the need for additional analgesics in the immediate post-procedural period.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •chronic pain condition
研究组 & 干预措施
Liposomal Bupivacaine Arm
Participants undergoing interventional radiology procedures will receive liposomal bupivacaine administered via local infiltration at the procedural site as part of peri-procedural pain management. The intervention will be performed using standard dosing and technique at the discretion of the treating physician. Pain scores and analgesic requirements will be collected following the procedure to assess outcomes.
干预措施: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (Drug)
结局指标
主要结局
Pain Scores
时间窗: pre-procedure, intra-procedure, Immediately post-procedure and 24 hours following the procedure
Patient-reported pain scores will be assessed using a standardized numeric rating scale (e.g., 0-10) following interventional radiology procedures in which liposomal bupivacaine is administered. Pain scores will be collected to evaluate peri-procedural analgesic effectiveness.
次要结局
- Post-Procedural Analgesic Requirements and Opioid Use(Cumulative Post-Procedural Analgesic Requirements and Opioid Use (0-24 Hours))
研究者
Rafael, Vazquez
Director of Non OR Anesthesiology
Massachusetts General Hospital