A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Pain Visual Analogue Scale (VAS)
研究概览
简要总结
Postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease hospital length of stay. However, local anesthetics, via wound infiltration, are often short-acting and do not meet the duration of postsurgical pain due to their solubility and protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. This formulation has been shown to have little to no adverse effects; although some studies have reported adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and dizziness. The occurrences of these adverse events were still less than the placebo cohort.
详细描述
All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical fixation would be included. Written, informed consent to enrollment will be recorded and included in the patient record. The study is designed around the standard of care for postsurgical pain management. There are no additional costs to the patient strictly related to this study.
Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical investigators at a single institution. A sealed, opaque envelope, selected in the pre-operative holding area, will accompany each patient participant to the operating room. The envelope will be opened at the conclusion of the fracture fixation to reveal patient assignment to either study Group 1 or Group 2. Once the total numbers of patients have completed their procedures and follow-up, the study will close.
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 over 18 years of age
- •Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation
排除标准
- •Allergy to ExparelTM or certain other local anesthetic agents
- •Surgery performed at an outside institution or by a different surgeon
- •Chronic analgesic users (defined as use of opioid medication >14 days in the past 3 months, or use of non-opioid pain medication >5 times per week
- •Pregnant females or females who think they may become pregnant
- •Peripheral neuropathy
- •Major psychiatric disease
- •Inability to comprehend the nature of the study
- •Unwillingness to provide signed informed consent
- •Markedly abnormal kidney function or renal disease
- •Non-English speaking
- •Signs or symptoms of compartment syndrome
研究组 & 干预措施
Control- Marcain
Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
干预措施: Bupivacaine/Exparel (Drug)
Experimental- Exparel
Group 2 will receive a mixture of non-liposomal bupivacaine and Exparel introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
干预措施: Bupivacaine/Exparel (Drug)
结局指标
主要结局
Change in Pain Visual Analogue Scale (VAS)
时间窗: 72 hours
Patients will be asked to complete a Pain Visual Analogue Scale every 2 hours for the first 12 hours of their stay (2, 4, 6, 8, 10, 12), and then again at 24, 30 and 72 hours into their hospitalization.
次要结局
- Pain Management Satisfaction(2 weeks, post-operatively)