Pain control for ankle fractures using a local anesthetic cocktail
A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
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 |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Lahey Clinic Academic / other |
| Locations | 1 site (Burlington, Massachusetts) |
| Trial ID | NCT03696199 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with bimalleolar ankle fractures requiring surgical intervention.
Not a fit: Patients with unifocal malleolar fractures or those ineligible for a peripheral nerve block may not benefit from this study.
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 performed: Other studies have shown promising results with similar pain management approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Burlington, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.