Randomized Controlled Trial for Ankle Fracture Pain Control

赞助:

合作者:

信息的提供 (责任方):

Eric Swart，University of Massachusetts, Worcester

追踪信息

首次提交日期 ^ICMJE

September 24, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

January 1, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Oral Narcotics / Morphine Milligram Equivalents (MME) given[ Time Frame: 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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Randomized Controlled Trial for Ankle Fracture Pain Control

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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. 2. 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. Secondary Aim: Demonstrate the use of long-acting local anesthetic as a viable pain management strategy in fracture surgery. Although long-acting local anesthetics have an established track record in arthroplasty, there is a paucity of evidence guiding their use in fractures. Small case series in trauma and foot/ankle patients have been encouraging, but a rigorously conducted, prospective trial in a relatively homogeneous group could generate pilot data to validate the use of long acting local anesthetics in fracture surgery. This knowledge may be translatable to other extremity injuries as well, having a greater impact than the scope of the proposed trial.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Long-Acting Local Anesthesia
The cocktail consists of: 0.5% Ropivicaine, 24.6 mL Clonidine 100 mcg/mL, 0.4mL Epinephrine 1mg/mL, 0.5mL Saline to total volume of 50 mL (24.5mL of saline) The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.
Drug: Regional Anesthesia
0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided

研究工具

No Intervention: Traditional Pain Control Care
Standard of care post-operative pain control with oral narcotics
Experimental: Regional Anesthesia
Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system
Experimental: Long-Acting Local Anesthesia
Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 1, 2020

预计主要完成日期

January 1, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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 Exclusion Criteria: - 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.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：89 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Eric Swart，University of Massachusetts, Worcester

研究赞助商 ^ICMJE

University of Massachusetts, Worcester

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Eric Swart, MD UMass Memorial Medical Center
Principal Investigator: Paul Matuszewski, MD University of Kentucky

PRS 账户

University of Massachusetts, Worcester

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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