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Clinical trial

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.

ID
Name
137271
Description
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.
Trial arms
Trial start
2021-05-15
Estimated PCD
2026-05-01
Trial end
2026-05-01
Phase
Early phase I
Treatment
Regional anesthesia group
bupivacaine 0.25% with epinephrine 1:400,000.
Arms:
Regional anesthesia group
Other names:
Marcaine (bupivacaine), Adrenalin (epinephrine)
Local multimodal analgesia group
5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Arms:
Local multimodal analgesia group
Other names:
MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Toradol (ketorolac), Marcaine (bupivacaine)
Size
200
Primary endpoint
Visual Analog Scale (VAS) pain
Pre-operative
Visual Analog Scale (VAS) pain
1-hour post-operative
Visual Analog Scale (VAS) pain
2-hour post -operative
Visual Analog Scale (VAS) pain
4-hour post-operative
Visual Analog Scale (VAS) pain
8-hour post-operative
Visual Analog Scale (VAS) pain
24-hour post-operative
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

2 products

1 indication

Organization
University of Utah
Product
Regional anesthesia group
Indication
Ankle Fractures
Product
Local Multimodal Analgesia