The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain Levels on a Visual Analog Scale ( VAS)
研究概览
简要总结
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.
详细描述
This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.
Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.
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
- 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
- •Patients at least 18 years old.
- •Male or Female
- •All racial and ethnic groups
- •Fractures and fracture/dislocations of the ankle
- •Patients who opt for surgical treatment of their fractures.
- •Patients who consent to be randomized.
- •Patients who are willing to follow-up for a minimum of 52 weeks.
排除标准
- •Patients younger than 18 years old
- •Patients who are on chronic opioids
- •Patients who abuse opioids
- •Patients who are unwilling to follow-up for a minimum of 52 weeks
- •Neurologic condition that could interfere with pain sensation
研究组 & 干预措施
Liposomal Bupivacaine with Bupivacaine
Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.
干预措施: Liposomal Bupivacaine with Bupivacaine (Drug)
结局指标
主要结局
Pain Levels on a Visual Analog Scale ( VAS)
时间窗: Immediate post-operative period until 72 hours post-operatively
A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.
次要结局
未报告次要终点
研究者
Roy Davidovitch, M.D.
Assistant Professor of Orthopaedic Surgery
Jamaica Hospital Medical Center