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Local Multimodal Analgesia vs Regional Anesthesia for Ankle Fracture

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
Isolated rotational ankle fracture requiring operative intervention
Be older than 18 years old
Must not have
Concomitant head injury
History of stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hour post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two methods of reducing post-operative pain in patients with rotational ankle fractures.

Who is the study for?
This trial is for individuals with isolated rotational ankle fractures who need surgery, can give informed consent, and communicate in English or Spanish. It's not for those with drug dependency history, stroke, major neurological issues, other leg fractures, allergies to injection ingredients used in the study, head injuries or open fractures.
What is being tested?
The study compares two pain control methods after ankle fracture surgery: one group receives local multimodal analgesia injections at the injury site; another gets regional anesthesia that numbs a larger area of the body.
What are the potential side effects?
Possible side effects may include discomfort at injection sites for both groups. The regional anesthesia might cause numbness beyond the target area temporarily. Allergic reactions are possible but participants with known allergies to these medications are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for a broken ankle caused by twisting it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a head injury along with my current condition.
Select...
I have had a stroke in the past.
Select...
I have other broken bones in my legs.
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I have a broken bone that is exposed through my skin.
Select...
I have a significant problem with my nervous system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hour post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hour post-operative for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Local multimodal analgesia groupExperimental Treatment1 Intervention
Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Group II: Regional anesthesia groupActive Control1 Intervention
Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,140 Previous Clinical Trials
1,697,530 Total Patients Enrolled
Justin Haller, MDPrincipal InvestigatorUniversity of Utah Orthopaedics
2 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Local Multimodal Analgesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05019638 — Phase < 1
Ankle Fracture Research Study Groups: Regional anesthesia group, Local multimodal analgesia group
Ankle Fracture Clinical Trial 2023: Local Multimodal Analgesia Highlights & Side Effects. Trial Name: NCT05019638 — Phase < 1
Local Multimodal Analgesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019638 — Phase < 1
~58 spots leftby May 2026
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