Clinical trial
Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
Name
117178
Description
The investigators goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores.
Trial arms
Trial start
2019-03-25
Estimated PCD
2026-03-01
Trial end
2026-03-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Saline injection
Saline
Arms:
Saline injection
Other names:
0.9%NaCl (sodium chloride) H2O (saline)
Multimodal injections
5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection).
2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection).
Arms:
Multimodal injections
Other names:
Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Catapres, Kapvay (clonidine), Toradol (ketorolac), 0.9%NaCl (sodium chloride) H2O (saline)
Size
150
Primary endpoint
Visual Analog Scale (VAS) pain
Pre-operative
Visual Analog Scale (VAS) pain
4-hours post-operative
Visual Analog Scale (VAS) pain
8-hours post-operative
Visual Analog Scale (VAS) pain
12-hours post-operative
Visual Analog Scale (VAS) pain
16-hours post-operative
Visual Analog Scale (VAS) pain
20-hours post-operative
Visual Analog Scale (VAS) pain
24-hours post-operative
Eligibility criteria
Inclusion Criteria:
* Patients who present with isolated tibial plateau fractures treated by the investigators
* English or Spanish speaking
Exclusion Criteria:
* Poly trauma injuries
* Any allergies to the medication used in the injections
* Significant head trauma (loss of consciousness, Glasgow Coma Scale (GCS)\<15, brain bleed) that interferes with the ability to provide informed consent.
* Non-English or Non-Spanish Speaking
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-12-04
1 organization
2 products
1 indication
Organization
University of UtahProduct
SalineIndication
Tibial Plateau FracturesProduct
Multimodal injections