Back to search results

Ankle Fracture Pain Control Study

This study is looking at ways to manage pain after surgery for ankle fractures. It compares a special long-acting local anesthesia "cocktail" (made of Ropivicaine, Clonidine, Epinephrine, and Saline) to a regional anesthesia (Ropivicaine given near nerves) or standard pain care. The goal is to see if these methods can reduce the amount of strong pain medication (oral narcotics/Morphine Milligram Equivalents) you need in the 72 hours after surgery. You may be able to join if you are 18 to 89 years old and have a specific type of ankle fracture (bimalleolar) that requires surgery. The study plans to enroll 70 participants, but its current status is unclear.

Study design
This is a randomized controlled trial, meaning participants are randomly assigned to one of three treatment groups. The study plans to enroll 70 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain medication use will be measured for 72 hours after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03696199

Randomized Controlled Trial for Ankle Fracture Pain Control

Recruiting
PHASE4Ages 18–89InterventionalTreatment
Lahey Clinic
~70 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:Long-Acting Local AnesthesiaRegional Anesthesia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oral Narcotics / Morphine Milligram Equivalents (MME) given
Measured over 72 postoperative hours

Conditions

Ankle Fractures

Explore related trials

Ankle Fracture

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Eric Swart, MD · PRINCIPAL_INVESTIGATOR · Lahey Hospital & Medical Center

Who to contact

Eric Swart, MD
[email protected]
781-744-2629
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
Isolated Injury

Exclusion

Unifocal malleolar fractures
Bimalleolar fractures where fixation of only one malleolus is planned
Posterior malleolus fractures requiring fixation
Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
Open injury
Patients treated with external fixation
Neurologic condition that would confound results (e.g. peripheral neuropathy)
Inability to consent
Chronic opioid use
History of opiate abuse
Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
Prisoners (unlikely to be accessible for follow-up)
Pregnant patients
Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).
Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.

What this trial measures

  • Oral Narcotics / Morphine Milligram Equivalents (MME) given72 postoperative hours

    The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.