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Local Anesthetic

Pain Control for Ankle Fracture

Phase 4

Recruiting

Led By Paul Matuszewski, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 postoperative hours

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for adults with a specific type of ankle fracture (bimalleolar) that requires surgery using medial and lateral incisions. It's not for those with certain other fractures, open injuries, chronic opioid use, or who can't consent. Pregnant women, non-English speakers without translator access, and people on certain medications are also excluded.Check my eligibility

What is being tested?

The study compares the pain control effectiveness of a long-acting local anesthetic 'cocktail' versus regional anesthesia in patients having surgery to fix their broken ankles. Participants will be randomly assigned to one of three groups in different medical centers.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site like pain or swelling, possible nerve damage from regional anesthesia leading to numbness or weakness, and allergic reactions to the anesthetics used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a specific type of ankle fracture that requires surgery with cuts on both sides of my ankle.

Select...

I have a three-part ankle fracture and won't have surgery on the back part.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 postoperative hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 postoperative hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 postoperative hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oral Narcotics / Morphine Milligram Equivalents (MME) given

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Regional AnesthesiaExperimental Treatment1 Intervention

Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system

Group II: Long-Acting Local AnesthesiaExperimental Treatment1 Intervention

Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system

Group III: Traditional Pain Control CareActive Control1 Intervention

Standard of care post-operative pain control with oral narcotics

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regional Anesthesia

2007

Completed Phase 4

~3530

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor

343 Previous Clinical Trials

986,540 Total Patients Enrolled

Lahey ClinicLead Sponsor

72 Previous Clinical Trials

245,175 Total Patients Enrolled

Paul Matuszewski, MDPrincipal InvestigatorUniversity of Kentucky

2 Previous Clinical Trials

85 Total Patients Enrolled

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI