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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hour post-operative
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 β€œYes” for the criteria below
Select...
I need surgery for a broken ankle caused by twisting it.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Scale (VAS) pain

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
1,102 Previous Clinical Trials
1,779,061 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 β€” 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 β€” Phase < 1
Local Multimodal Analgesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019638 β€” Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the capability to join this research study?

"This medical research is enrolling 200 individuals that have suffered ankle fractures, and are aged between 18-80."

Answered by AI

To what kind of conditions is Local multimodal analgesia typically administered?

"Local multimodal analgesia group is a viable option for managing unresponsive bradycardia, permphigus, and pupillary abnormalities."

Answered by AI

Is this trial seeking out elderly participants?

"The recruitment phase of this medical experiment is inviting all participants over 18 years old and under 80 to join."

Answered by AI

What have other research groups uncovered while exploring Local multimodal analgesia?

"Presently, 200 clinical trials for Local multimodal analgesia group are ongoing and 42 of them have moved to the third phase. These experiments mainly take place in Germantown, Tennessee but there are also 339 other locations where investigations into this treatment methodology can be found."

Answered by AI

What is the aggregate participation rate for this research initiative?

"Currently, this particular trial is not enrolling participants. Initially listed on May 15th 2021 and last updated on March 14th 2022, it has closed its recruitment process for the time being. However, if you are still in search of studies to participate in; there are 354 trials recruiting patients with ankle fractures and 200 clinical studies actively seeking individuals who qualify as part of a Local Multimodal Analgesia group."

Answered by AI

Are there any vacancies open to trial participants?

"At present, this experiment is not recruiting any participants. The initiative was first posted on May 15 2021 and last updated on March 14 2022. If you are in search of other trials, there are 354 studies with ankle fractures actively searching for patients as well as 200 investigations centred around Local multimodal analgesia that require volunteers."

Answered by AI
~78 spots leftby May 2026