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临床试验/NCT01599403
NCT01599403已完成不适用

Comparative Effectiveness of Continuous Thoracic Paravertebral Blocks Versus Thoracic Epidural and Continuous Intercostal Blocks Versus Patient-Controlled Anesthesia in Traumatic Rib Fracture Patients

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Primary Outcome: Difference in Pain Scores at 48hrs

研究概览

简要总结

The primary objective of this study is to investigate whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2.

详细描述

Rib fractures are the most common injury sustained following blunt trauma. Ziegler and Agarwal noted that in a population of more than 7000 trauma patients, 10% had fractured ribs. These injuries are normally the hallmark of significant chest trauma; and as the number of fractured ribs increases, there is an exponential increase in morbidity and mortality.

This injury therefore poses a challenging problem from both pulmonary and analgesia standpoints. Significant morbidity is often the result of hypoventilation leading to atelectasis, pneumonia, and respiratory failure. Pain management has been recognized as an important factor in preventing these complications.

Good analgesia may help to improve a patient's respiratory mechanics, leading to a decreased need for mechanical ventilatory support, a shortened hospital stay, and can dramatically alter the course of recovery impacting both morbidity and mortality.

For healthy patients with one to two fractured ribs, systemic analgesics may suffice. For more than three to four fractured ribs, studies and experience have reaffirmed the superior analgesia made possible with continuous thoracic epidural, continuous thoracic paravertebral, and continuous intercostal block, however, a comparative head to head trial comparing the relative merits and disadvantages of each technique has not been undertaken in multiple rib fracture patients. Placing a catheter, which is possible with the use of all three techniques, allows the continuation of analgesia for multiple days with just one block, which is an essential option when treating patients that are likely to need extended analgesia.

All options are not available for all patients, however, as the current American Society of Regional Anesthesiology advises against the performance of epidural or paravertebral blocks in patients with abnormal INR (at the BWH, equal or above 1.2, and/or treatment with other anticoagulants such gpIIb/IIIa inhibitors (heparin and heparin-like medications are usually acceptable within certain dosing time frames).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligibility Criteria
  • •A subject must meet the following criteria to take part in the study:
  • •Inclusion Criteria
  • •Subjects 18 years of age and greater
  • •Inpatient on the BWH SICU, MICU, or hospital floor ward
  • •Non-intubated at the time of block placement
  • •Traumatic Rib Fractures three or greater
  • •Block able to be placed within 12-24 hours of presentation to the emergency room
  • •Ability to provide written informed consent.
  • •Compliance with all ASRA and BWH Regional Anesthesia in Anticoagulated Patient guidelines for coagulation status.

排除标准

  • •Subject is pregnant
  • •Subject not expected to survive 48 hours due to traumatic injuries
  • •Allergy to Ropivacaine or other local anesthetic
  • •Any significant concomitant injuries potentially confounding data acquisition (e.g., traumatic brain injury, long bone fractures, intra-abdominal injuries)
  • •Known allergy to lidocaine
  • •Inability to provide written, informed consent
  • •Known opioid medication dependence
  • •Non-compliance with ARSA and BWH Regional Anesthesia in Anticoagulated Patient Guidelines.

研究组 & 干预措施

Paravertebral Block

Active Comparator

Patients will receive 1 or 2 paravertebral catheters for ongoing infusion of local anesthestic

干预措施: Paravertebral Block (Procedure)

Patient Controlled Anesthesia

No Intervention

Standard usual care

Epidural Block

Experimental

Intervention:

Patients will have epidural catheters placed for the infusion of local anesthetic solution to control pain (if qualified for this approach and randomized here)

干预措施: Epidural Block (Procedure)

Intercostal Nerve Block

Active Comparator

Patients will receive intercostal catheters for the infusion of local anesthetic solution to control pain(if qualified for this arm and randomized here)

干预措施: Intercostal Nerve Block (Procedure)

结局指标

主要结局

Primary Outcome: Difference in Pain Scores at 48hrs

时间窗: 2 days

The primary question investigators wish to answer in this study is whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2 as measured by visual analog pain scales at 48 hours post treatment.

次要结局

未报告次要终点

研究者

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

Gyorgy Frendl

Director, Surgical ICU Translational Research (STAR) Center

Brigham and Women's Hospital

研究点 (1)

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