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临床试验/NCT03696199
NCT03696199招募中4 期

A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures

Lahey Clinic1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年9月1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
招募中
发起方
Lahey Clinic
入组人数
70
试验地点
1
主要终点
Oral Narcotics / Morphine Milligram Equivalents (MME) given

研究概览

简要总结

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

详细描述

This study is a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Primary Hypothesis Driven Aims:

  1. Determine the effectiveness of a local anesthesia "cocktail" compared to regional block or standard of care in controlling pain in operatively treated ankle fractures. Nearly one out of ten fractures treated by both orthopaedic traumatologists and general orthopaedic surgeons taking call are ankle fractures. As such, effective pain control in this group of patients represents an opportunity to make a large impact, especially in the context of the current opioid epidemic. Improved pain control can help improve patient satisfaction, outcomes, decrease length of stay, cost of care, and complications associated with traditional narcotic use.
  • Hypothesis 1A: Patients receiving the intraoperative cocktail will have improved post-operative pain control compared to those receiving a peri-operative nerve block or standard of care.
  • Hypothesis 1B: Patients receiving the intraoperative cocktail or peri-operative nerve block will have improved post-operative pain control when compared to standard of care.
  • Null Hypothesis 1: There will be no difference in post-operative pain control between all treatment arms.
  1. Determine the economic impact of cocktail and regional blocks in ankle fractures. A common concern with the use of regional blocks is the cost of the additional procedure, along with logistic delays which are associated with coordinating a separate procedure. This study would provide valuable data about the additional costs associated with regional blocks and with cocktail administration which could help aid in making economically conscious treatment decisions.
  • Hypothesis 2: Local cocktail administration will have significantly lower costs than regional block, and not be significantly more expensive than standard of care.
  • Null Hypothesis 2: There is no difference in cost between the modalities.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included
  • Isolated Injury

排除标准

  • Unifocal malleolar fractures
  • Bimalleolar fractures where fixation of only one malleolus is planned
  • Posterior malleolus fractures requiring fixation
  • Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
  • Open injury
  • Patients treated with external fixation
  • Neurologic condition that would confound results (e.g. peripheral neuropathy)
  • Inability to consent
  • Chronic opioid use
  • History of opiate abuse
  • Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
  • Prisoners (unlikely to be accessible for follow-up)
  • Pregnant patients
  • Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).
  • Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.

研究组 & 干预措施

Regional Anesthesia

Experimental

Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system

干预措施: Regional Anesthesia (Drug)

Long-Acting Local Anesthesia

Experimental

Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system

干预措施: Long-Acting Local Anesthesia (Drug)

结局指标

主要结局

Oral Narcotics / Morphine Milligram Equivalents (MME) given

时间窗: 72 postoperative hours

The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.

次要结局

未报告次要终点

研究者

发起方
Lahey Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Francis Swart

Principal Investigator

Lahey Clinic

研究点 (1)

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