Long-Acting Local Anesthesia for Ankle Fracture

Phase-Based Progress Estimates
University of Kentucky, Lexington, KYAnkle FractureLong-Acting Local Anesthesia - Drug
18 - 89
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new pain medication for people with broken ankles.

Eligible Conditions
  • Ankle Fracture

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 72 postoperative hours

72 postoperative hours
Oral Narcotics / Morphine Milligram Equivalents (MME) given

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Traditional Pain Control Care
1 of 3
Regional Anesthesia
1 of 3
Long-Acting Local Anesthesia
1 of 3

Active Control

Experimental Treatment

70 Total Participants · 3 Treatment Groups

Primary Treatment: Long-Acting Local Anesthesia · No Placebo Group · Phase 4

Regional Anesthesia
Experimental Group · 1 Intervention: Regional Anesthesia · Intervention Types: Drug
Long-Acting Local Anesthesia
Experimental Group · 1 Intervention: Long-Acting Local Anesthesia · Intervention Types: Drug
Traditional Pain Control CareNoIntervention Group · 1 Intervention: Traditional Pain Control Care · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Regional Anesthesia
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 postoperative hours

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
312 Previous Clinical Trials
753,789 Total Patients Enrolled
Lahey ClinicLead Sponsor
70 Previous Clinical Trials
244,968 Total Patients Enrolled
Paul Matuszewski, MDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
55 Total Patients Enrolled
Eric Swart, MDPrincipal Investigator - Lahey Hospital & Medical Center
UMass Memorial Medical Center-Memorial Campus, UMass Memorial Medical Center-University Campus
Harvard Medical School (Residency)
1 Previous Clinical Trials
55 Total Patients Enrolled

Eligibility Criteria

Age 18 - 89 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
We will include patients with syndesmotic injuries because it is hard to confirm the injury before the surgery.
You have a certain type of ankle fracture that does not require surgery on the back part of the ankle.
You have a single injury without any other medical conditions.

Frequently Asked Questions

Would I be a good candidate for this clinical research?

"This trial is looking for 70 patients, aged 18 to 89, who have ankle fractures that meet the following criteria: Isolated Injury, Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned. Syndesmotic injuries will be included due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively. Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included." - Anonymous Online Contributor

Unverified Answer

What is the governmental organization's opinion on Long-Acting Local Anesthesia?

"Long-Acting Local Anesthesia received a score of 3 because Phase 4 trials are conducted after the treatment has been approved." - Anonymous Online Contributor

Unverified Answer

Are there opportunities for patients to enroll in this trial?

"Yes, the latest information from clinicaltrials.gov suggests that this trial is still open for recruitment. The study was first posted on January 1st 2020 and was last updated on August 18th 2022. They are looking to enroll a total of 70 patients across 3 sites." - Anonymous Online Contributor

Unverified Answer

Does this research allow people who are over 45 years old to participate?

"This study includes all patients aged 18-89, as specified in the eligibility requirements." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.