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临床试验/NCT02349542
NCT02349542已完成4 期

The Safety of Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

OrthoCarolina Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the use of a standardized periarticular injection containing free bupivacaine and liposomal bupivacaine.

详细描述

Total knee arthroplasty (TKA) is a commonly performed and successful surgical procedure that has been shown to dramatically decrease pain and improve patient's function and quality of life. Certain patients may present with significant pain and limitations due to pain in both knees and based on age, health and degree of deformity may be candidates for bilateral simultaneous total knee arthroplasty. The safety and efficacy of simultaneous bilateral total knee arthroplasty has been well documented in the literature.

Inadequate postoperative pain control following TKA has been one of the greatest sources of patient dissatisfaction following total knee arthroplasty. Traditionally, it has been managed with parenteral and oral narcotics. Recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures. These multimodal regimens vary and consist of any number of medications including non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. These multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.

One of the newest modalities introduced on the market is liposomal bupivacaine (Exparel). Liposomal bupivacaine is a lipid encapsulated bupivacaine that allows for depo administration of the medication into the soft tissue during a surgical procedure. The lipids are engineered to slowly release over an approximately 72 hour time period, resulting in the slow release of free bupivacaine in to the soft tissue of the surgical site. This has the proposed advantage of a longer duration of analgesia compared to standard bupivacaine injections.

Liposomal bupivacaine is applied in a periarticular injection at the conclusion of TKAs to aid in post-operative pain control. Due to the lipid encapsulation of the bupivacaine, only 3% free bupivacaine is released into the tissue at initial infiltration, with the remainder released slowly over approximately a 72 hour time frame. To cover, this gap period, the liposomal bupivacaine is mixed with standard bupivacaine to allow for an immediate analgesic effect.

A potential risk, although low, is the concern for bupivacaine toxicity. Toxicity from bupivacaine is associated with central nervous system issues (seizures) and cardiac toxicity. Toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. With the use of bupivacaine into each surgical site, there is a theoretical risk, if administered intra-vascularly, of bupivacaine toxicity. To date, no study has evaluated the safety of liposomal bupivacaine when used in simultaneous bilateral total knee arthroplasty. The use of liposomal bupivacaine is FDA approved for infiltration of one vial into one surgical site. Other specialties have evaluated the use of one vial of liposomal bupivacaine into two surgical sites (breast augmentation) at one surgery without any adverse events.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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 deemed appropriate candidates for simultaneous bilateral total knee arthroplasty.
  • Patients receiving general anesthesia
  • Understands the local language and is willing and able to follow the requirements of the protocol
  • Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

排除标准

  • Patients less than 18 years of age
  • Allergy to bupivacaine
  • Allergy to epinephrine
  • Patients who are not medically cleared to undergo bilateral total knee replacement surgery, or
  • Patient-reported liver impairment (per investigator discretion)
  • Patient-reported renal impairment (per investigator discretion)
  • Patients receiving spinal anesthesia
  • Females who are pregnant or lactating

研究组 & 干预措施

Liposomal bupivacaine

Experimental

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Adverse Events

时间窗: Up to 72 hours following injection

Number of Participants with Adverse Events

次要结局

  • Plasma Bupivacaine Levels(Up to 72 hours following injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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