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临床试验/NCT02341079
NCT02341079撤回2 期

Prospective Randomized Trial Comparing Intraoperative Liposomal Bupivacaine Injection With Indwelling Femoral Nerve Blockade in Early Postoperative Pain Control for Primary Total Knee Arthroplasty

United States Naval Medical Center, San Diego1 个研究点 分布在 1 个国家开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
发起方
试验地点
1
主要终点
Oral and Intravenous Opioid Consumption

研究概览

简要总结

The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.

详细描述

Postoperative pain control in total knee arthroplasty is generally managed by a multimodal approach of premedication, epidural and/or peripheral nerve blocks, narcotic medications, and anti-inflammatories. Multiple studies have evaluated the efficacy of anesthetic "cocktails" of various medications for local tissue infiltration to aide in controlling postoperative pain. A recent systematic review supported the use of local anesthetic infiltration in a single intraoperative dose as an adjunct to femoral nerve block in the relief of pain; with combinations of ropivacaine, ketorolac, and adrenaline providing the best results. Several studies noted decreases in opioid consumption and overall pain scores in the perioperative period.

A novel compound, liposomal bupivacaine (EXPAREL®, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA), has been proposed for use in total knee arthroplasty. To our knowledge, only one randomized controlled trial involving use of this compound in total knee arthroplasty has been published and was performed as a phase two dose ranging trial comparing liposomal bupivacaine to bupivacaine HCl. No statistically significant difference between the two compounds was shown, but a trend towards benefit in short term pain control was shown with EXPAREL 532mg.

Our current pain management regimen utilizes the multimodal approach of neuraxial anesthesia, indwelling femoral nerve catheter, opioids, and anti-inflammatory medications. The regional anesthesia service manages postoperative pain while the indwelling femoral nerve catheter is in place. The epidural is utilized for early postoperative analgesia and thromboprophylaxis. The epidural is discontinued on post-operative day 1 and the femoral nerve catheter is removed by the morning of postoperative day 3. Although femoral nerve catheters provide excellent pain control following TKA, there are associated disadvantages. Most notably there is inherent quadriceps weakness which places the patient at increased fall risk. To reduce the risk of falling, patients must wear a knee immobilizer with ambulation until the catheter is removed and quadriceps function has returned. This may delay the ability to actively participate in physical therapy.

The purpose of our present study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain. The investigators aim to show equivalency between the two treatment modalities. Our hypothesis is that a systematic local infiltration of liposomal bupivacaine provided intraoperatively is equally efficacious as femoral indwelling peripheral nerve blockade in immediate postoperative pain control with more rapid progression with physical therapy.

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

  • Age over 18 years old
  • Undergoing unilateral primary total knee arthroplasty

排除标准

  • Revision total knee arthroplasty
  • Bilateral total knee arthroplasty
  • Prior allergy or adverse reaction to local anesthetic
  • Hepatic dysfunction

研究组 & 干预措施

Femoral Nerve Blockade

Active Comparator

Femoral nerve block delivered via indwelling femoral nerve catheter

干预措施: Indwelling femoral nerve block (Drug)

Bupivacaine Liposome Injection

Experimental

Intraoperative intracapsular injection of bupivacaine liposome

干预措施: Bupivacaine Liposome Injection (Drug)

结局指标

主要结局

Oral and Intravenous Opioid Consumption

时间窗: 0-5 days (during hospitalization)

Oral and intravenous opioid use calculated in terms of morphine equivalents

Visual Analog Pain Scale

时间窗: 0-3 months

10cm VAS scale completed by the patient at set intervals postoperatively

Hospital for Special Surgery (HSS) Knee Scores

时间窗: 0-3 months

Standardized functional clinical score for knee symptoms

次要结局

  • Time to straight leg raise with physical therapy(0-5 days (during hospitalization))
  • Length of Hospital Stay(0-5 days)
  • Distance ambulated with physical therapy(0-5 days (during hospitalization))
  • Postoperative range of motion(0-3 months)
  • Postoperative complication rate(0-3 months)
  • Plasma bupivacaine concentrations(0-5 days (during hospitalization))

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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