Pain control for ankle fractures using a local anesthetic cocktail
Official title: A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
Run by Lahey Clinic · NCT03696199 · Data updated 2026-11-12
This study tests if a special mix of long-lasting local anesthetics can help people with ankle fractures feel less pain after surgery compared to standard pain relief methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Lahey Clinic Academic / other |
| Locations | 1 site (Burlington, Massachusetts) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT03696199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with bimalleolar ankle fractures requiring surgical intervention.
✕Probably not a fit
Patients with unifocal malleolar fractures or those ineligible for a peripheral nerve block may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, three-armed, prospective randomized control trial investigates the effectiveness of a long-acting local anesthetic cocktail in patients undergoing surgical fixation of ankle fractures. The study aims to compare the pain control provided by this cocktail against traditional regional blocks and standard care methods. By focusing on improving post-operative pain management, the trial seeks to enhance patient satisfaction, reduce hospital stays, and minimize complications associated with opioid use. The economic impact of these pain management strategies will also be evaluated.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for patients with ankle fractures, reducing reliance on opioids.
How similar studies have gone: Other studies have shown promising results with similar pain management approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Eric Swart, MD — Lahey Hospital & Medical Center
- Study coordinator: Eric Swart, MD
- Email: eric.f.swart@lahey.org
- Phone: 781-744-2629
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Bioabsorbable headless screws for ankle, knee, and elbow fractures in kids and teens
A post-market follow-up study in pediatric and adolescent patients is testing how well and safely Bioabsorbable Inion CompressOn screws perform for fixing ankle, knee, and elbow fractures over four years.
-
Ankle Muscle Power Program to Help Return to Duty After an Ankle Fracture
This trial tests whether adding ankle muscle power exercises to standard physical therapy helps adults 18–50 recover strength, function, and readiness to return to duty after a surgically fixed ankle fracture.
-
Repairing the deltoid ligament in unstable ankle fractures
This study tests whether sewing the deep deltoid ligament in adults with unstable Weber B ankle fractures leads to better function and less long-term arthritis than fixing the outer ankle bone alone.
-
Mild electrical stimulation to boost recovery after ankle fracture surgery
This trial will try neuromuscular electrical stimulation for people recovering from ankle fracture repair to see if it improves calf strength and walking and functional ability.
-
Repairing ankle syndesmosis with early full weight bearing
This study is testing a new ankle surgery method to see if it helps people with certain ankle fractures recover faster by allowing them to put weight on their foot sooner.
-
Hardware removal after ankle fracture surgery
This study tests whether removing hardware after ankle fracture surgery improves pain-related disability versus not removing it in adults who previously had ankle fracture repair.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.