Randomized Controlled Trial for Ankle Fracture Pain Control

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Eric Swart，University of Massachusetts, Worcester

Tracking Information

First Submitted Date ^ICMJE

September 24, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

January 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Randomized Controlled Trial for Ankle Fracture Pain Control

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 1, 2020

Estimated Primary Completion Date

January 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Eric Swart，University of Massachusetts, Worcester

Study Sponsor ^ICMJE

University of Massachusetts, Worcester

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

University of Massachusetts, Worcester

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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