Local Multimodal Analgesia vs Regional Anesthesia for Ankle Fracture

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Justin Haller, MD

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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.

Inclusion Criteria

I need surgery for a broken ankle caused by twisting it.

Ability to provide informed consent

I can talk or email the research team.

Exclusion Criteria

I have a head injury along with my current condition.

Prior drug dependency

Allergies to any of the ingredients in the local injection or peripheral nerve block

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either local multimodal analgesia or regional anesthesia for pain management post-surgery

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and narcotic usage at 1, 2, 4, 8, and 24 hours post-operatively

24 hours

Multiple assessments (in-person)

Extended Follow-up

Participants are monitored for pain levels and narcotic usage up to 8 weeks post-operatively

8 weeks

Treatment Details

Interventions

• Local Multimodal Analgesia
• Regional Anesthesia

Trial Overview 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.

Participant Groups

Group I: Local multimodal analgesia group Experimental Treatment 1 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 group Active Control 1 Intervention

Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+