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Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures

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ClinicalTrials.gov Identifier: NCT05019638
Recruitment Status : Enrolling by invitation
First Posted : August 25, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Justin Haller, University of Utah

Brief Summary:
The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures.

Condition or disease Intervention/treatment Phase
Ankle Fractures Drug: Regional anesthesia group Drug: Local multimodal analgesia group Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures.
Actual Study Start Date : May 15, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Active Comparator: Regional anesthesia group
Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.
Drug: Regional anesthesia group
bupivacaine 0.25% with epinephrine 1:400,000.
Other Names:
  • Marcaine (bupivacaine)
  • Adrenalin (epinephrine)

Experimental: Local multimodal analgesia group
Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Drug: Local multimodal analgesia group
5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Other Names:
  • MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine)
  • Adrenalin (epinephrine)
  • Toradol (ketorolac)
  • Marcaine (bupivacaine)




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) pain [ Time Frame: Pre-operative ]
    VAS pain score (0 no pain - 10 severe pain)

  2. Visual Analog Scale (VAS) pain [ Time Frame: 1-hour post-operative ]
    VAS pain score (0 no pain - 10 severe pain)

  3. Visual Analog Scale (VAS) pain [ Time Frame: 2-hour post -operative ]
    VAS pain score (0 no pain - 10 severe pain)

  4. Visual Analog Scale (VAS) pain [ Time Frame: 4-hour post-operative ]
    VAS pain score (0 no pain - 10 severe pain)

  5. Visual Analog Scale (VAS) pain [ Time Frame: 8-hour post-operative ]
    VAS pain score (0 no pain - 10 severe pain)

  6. Visual Analog Scale (VAS) pain [ Time Frame: 24-hour post-operative ]
    VAS pain score (0 no pain - 10 severe pain)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • isolated rotational ankle fracture
  • operative intervention needed
  • English or Spanish speaking
  • provide informed consent
  • able to communicate with the research team via email or phone

Exclusion Criteria:

  • sustain concomitant head injury
  • additional lower extremity fracture(s)
  • open fracture
  • prior drug dependency
  • allergies to any of the ingredients in the local injection or peripheral nerve block
  • any history of stroke
  • major neurological deficit

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): NCT05019638


Locations
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United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
University of Utah Orthopedics
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Justin Haller, MD University of Utah Orthopaedics
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Responsible Party: Justin Haller, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT05019638    
Other Study ID Numbers: 137271
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Keywords provided by Justin Haller, University of Utah:
rotational ankle fractures
regional anesthesia
local multimodal injection
pain
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries
Ketorolac
Epinephrine
Racepinephrine
Morphine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics