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临床试验/NCT04360421
NCT04360421终止4 期

Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation

Loma Linda University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年4月21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
7
试验地点
1
主要终点
Total opioid use

研究概览

简要总结

The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • 18 years of age or older
  • Patients who underwent unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral [1 year retrospective analysis]
  • Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral

排除标准

  • Minor amputations
  • Liver dysfunction (impaired metabolism of Amides)
  • Concomitant psychiatric or chronic pain disorders
  • Pregnancy
  • Amide anesthetic allergy
  • Presence of perioperative sepsis or acute organ dysfunction
  • Need for ICU admission at any point
  • Polytrauma
  • Quadriplegic/Paraplegic/Insensate

研究组 & 干预措施

Intraoperative liposomal bupivacaine field block

Experimental

Patients will receive the maximum dosage of liposomal bupivacaine allowed for their body weight or the full vial, whichever is less. Injected once, along the incision before closure of the skin.

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Total opioid use

时间窗: Up to 4 weeks

Total morphine equivalent

Total cost of stay

时间窗: Up to 4 weeks

US Dollar cost

次要结局

  • Pain scores(Up to 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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