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临床试验/NCT03827213
NCT03827213终止2 期

Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年1月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
23
试验地点
1
主要终点
Opioid Requirements Assessed at 24 Hours Post-surgery

研究概览

简要总结

The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).

详细描述

While placing an indwelling nerve catheter can prolong pain control, it can also have drawbacks and complications. While major complications like pneumothorax and hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are rare, minor adverse effects associated with CPNBs may be more common. They include infection and anatomical damage to blood vessels and nerves due to the indwelling catheter. In addition, catheters take a significantly longer time to set up and place than single shot blocks, which is important as there is often a rush to block patients and trying to get them into the operating room on time. Furthermore, the needle used for catheter placement is larger than the single shot needles, which creates more discomfort to patients during the nerve block. The catheter itself is taped around the entire sides and back of the patient's neck, which is also uncomfortable for patients. Because of how shallow the interscalene block is, the catheter is often found to be dislodged from operating room positioning, patient transport or movement, which negates the placement of the catheter. An indwelling catheter must also be followed up by the acute pain service team until the catheter is removed.

Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96 hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks. The sustained release of local anesthetic could theoretically act similarly to the continuous infusion of local anesthetic through an indwelling interscalene catheter, and could thus avoid the need for placement of a catheter. Current existing data, although inconclusive, has in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of the On-Q pump and the local anesthesia needed for the pump together cost $390 for each indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve block, would avoid the extra costs and time needed for a catheter placement.

The investigators would like to perform a prospective randomized controlled pilot study to examine the efficacy of single shot interscalene blocks using Exparel versus the traditional interscalene catheter used at our institution. The purpose of the study the investigators are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than indwelling interscalene catheter in patients who undergo total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing indwelling interscalene catheters.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesia (ASA) 1, 2, and 3
  • Ages 40-74
  • Patients scheduled for total shoulder replacement

排除标准

  • ASA 4 and 5
  • Pre-existing pain disorder
  • Regular consumption of chronic pain medication
  • pregnant women
  • any medical condition such as a clotting disorder
  • anatomic abnormality that precludes use of an indwelling scalene catheter
  • Body Mass Index (BMI) >40
  • Patient refusal
  • Pre-existing diabetic neuropathy or Hemoglobin A1c >9
  • Failed block

研究组 & 干预措施

Single shot Interscalene Nerve Block

Experimental

This group will receive an interscalene nerve block. This will be administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.

干预措施: Exparel (Drug)

Indwelling Interscalene Catheter

Active Comparator

This group will receive an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump will be set at a rate of 4 mL/hr.

干预措施: Indwelling Interscalene Catheter (Device)

结局指标

主要结局

Opioid Requirements Assessed at 24 Hours Post-surgery

时间窗: 24 Hours post-surgery

Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.

次要结局

  • Intra-Operative Opioid Requirements(Duration of Surgery (Approximately 3 hours))
  • Opioid Requirements Assessed at 8-hours Post-surgery(8 hour post-surgery)
  • Pain Score in Post Anesthesia Care Unit (PACU)(During time in PACU (up to 5 hours))
  • Opioid Requirements Assessed at 48 Hours Post-surgery(48 hours post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elilary Montilla Medrano

Assistant Professor of Anesthesiology

Montefiore Medical Center

研究点 (1)

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