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Randomized Controlled Trial for Ankle Fracture Pain Control

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ClinicalTrials.gov Identifier: NCT03696199
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Eric Francis Swart, Lahey Clinic

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.

Condition or disease Intervention/treatment Phase
Ankle Fractures Drug: Long-Acting Local Anesthesia Drug: Regional Anesthesia Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Regional Anesthesia
0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided
Other Name: Ropivicaine

Experimental: Long-Acting Local Anesthesia
Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system
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.

Other Name: Local Cocktail




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696199


Contacts
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Contact: Eric Swart, MD 781-744-2629 eric.f.swart@lahey.org
Contact: John Garfi, MS 781-744-2629 john.garfi@lahey.org

Locations
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United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Eric Swart, MD    781-744-2629      
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Eric Swart, MD Lahey Hospital & Medical Center
  Study Documents (Full-Text)

Documents provided by Eric Francis Swart, Lahey Clinic:
Study Protocol  [PDF] June 1, 2018

Publications:

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Responsible Party: Eric Francis Swart, Principal Investigator, Lahey Clinic
ClinicalTrials.gov Identifier: NCT03696199    
Other Study ID Numbers: H00014155
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs