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Multimodal Pain Relief for Tibial Plateau Fractures
Phase < 1
Waitlist Available
Led By Justin Haller, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with isolated tibial plateau fractures treated by the investigators
Be older than 18 years old
Must not have
Non-English or Non-Spanish Speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hours post-operative
Summary
This trial will test if multimodal analgesia (different types of pain relief) is more effective than just one type for treating tibial plateau fractures.
Who is the study for?
This trial is for English or Spanish speakers with isolated tibial plateau fractures treated by the study's investigators. It excludes those allergic to injection medications, with significant head trauma affecting consent ability, and patients with multiple traumatic injuries.
What is being tested?
The study tests the effectiveness of multimodal analgesia injections versus saline injections in reducing pain after tibial plateau fracture surgery. Effectiveness is measured by lower reported pain scores from patients.
What are the potential side effects?
While specific side effects are not listed, typical reactions might include discomfort at the injection site, potential allergic reactions if unknown allergies exist, and possible systemic effects depending on the drugs used in multimodal analgesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tibial plateau fracture treated by the study's doctors.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-hours post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hours post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analog Scale (VAS) pain
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Multimodal injectionsExperimental Treatment1 Intervention
Superficial multimodal analgesia composition includes 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline.
Deep medial multimodal analgesia composition includes 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline.
Group II: Saline injectionPlacebo Group1 Intervention
Saline
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,698,930 Total Patients Enrolled
2 Trials studying Tibial Plateau Fracture
85 Patients Enrolled for Tibial Plateau Fracture
Justin Haller, MDPrincipal InvestigatorUniversity of Utah Orthopaedics
2 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.I have a tibial plateau fracture treated by the study's doctors.You have multiple injuries from an accident or trauma.I do not speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Saline injection
- Group 2: Multimodal injections
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.