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临床试验/NCT03922620
NCT03922620终止4 期

Liposomal Bupivacaine vs Peripheral Nerve Block

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年1月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
1
试验地点
1
主要终点
Visual Analog Scale Pain Score

研究概览

简要总结

Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients.

详细描述

Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. Liposomal bupivacaine is an analgesic that is suspended in lipids to allow for gradual release of the analgesic over a 72-hour period (NAMDARI). From prior literature, the utilization of local analgesics infiltrated into surgical sites have been shown to reduce pain in the immediate post-operative period in foot and ankle surgery (GADEK). However, the evaluation of liposomal bupivacaine in foot and ankle surgery is limited. One prospective study found that the addition to liposomal bupivacaine to a multi-modal pain management protocol for forefoot surgery resulted in decreased pain scores during the first four post-operative days as well as fewer refills of opioid pain medication prescriptions, although both findings were not statically significant (ROBBINS). As the general medical community and public policy makers continue to focus on decreasing the amount of opioid pain medications prescribed and available in the community due to the opioid epidemic, liposomal bupivacaine has the potential to be a useful adjunct in the management of post-operative pain without reliance on opioid prescriptions. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients. Furthermore, this study aims to determine if there are differences in the amount of opioid medications utilized for post-operative pain control, patient satisfaction scores, functional outcomes, complications, and unscheduled healthcare contact between the two groups. In order to accomplish these aims, a randomized, controlled investigation will be conducted.

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
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

入选标准

  • Patients 18 years of age or older
  • Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy)

排除标准

  • Patients who are undergoing revision surgical procedure
  • Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure
  • Patients who have allergies to any of the medications or components of medications investigated in the study
  • Patients currently incarcerated
  • Patients who cannot read and speak English

研究组 & 干预措施

Liposomal Bupivacaine Group

Experimental

No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.

干预措施: Liposomal bupivacaine (Drug)

Peripheral Nerve Block Group

Active Comparator

Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration

干预措施: Peripheral Nerve Block (Drug)

结局指标

主要结局

Visual Analog Scale Pain Score

时间窗: Baseline and 6 weeks

Best 0-10 worst - Continuous scale to measure current pain level

次要结局

  • Morphine Equivalents(0-6 weeks)
  • Range of Motion(0-6 weeks)
  • Investigator-developed, Pain Satisfaction Score(0-6 weeks)
  • Number of Participants With Complications(6 weeks)
  • Number of Participants With Unscheduled Healthcare Contact(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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