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Randomized Controlled Trial for Ankle Fracture Pain Control

Sponsor
Lahey Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03696199
Collaborator
(none)
70
Enrollment
1
Location
3
Arms
41
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

  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.

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 Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Local Cocktail

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oral Narcotics / Morphine Milligram Equivalents (MME) given [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805

    Sponsors and Collaborators

    • Lahey Clinic

    Investigators

    • Principal Investigator: Eric Swart, MD, Lahey Hospital & Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Eric Francis Swart, Principal Investigator, Lahey Clinic
    ClinicalTrials.gov Identifier:
    NCT03696199
    Other Study ID Numbers:
    • H00014155
    First Posted:
    Oct 4, 2018
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    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:
    Fractures, Bone
    Ankle Fractures
    Anesthetics

    Study Results

    No Results Posted as of Aug 22, 2022