NCT03696199 Randomized Controlled Trial for Ankle Fracture Pain Control
| NCT ID | NCT03696199 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lahey Clinic |
| Condition | Ankle Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2020-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
Eligibility 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.
Contact & Investigator
Eric Swart, MD
PRINCIPAL INVESTIGATOR
Lahey Hospital & Medical Center
Frequently Asked Questions
Who can join the NCT03696199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Ankle Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03696199 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03696199 currently recruiting?
Yes, NCT03696199 is actively recruiting participants. Contact the research team at eric.f.swart@lahey.org for enrollment information.
Where is the NCT03696199 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT03696199 clinical trial?
NCT03696199 is sponsored by Lahey Clinic. The principal investigator is Eric Swart, MD at Lahey Hospital & Medical Center. The trial plans to enroll 70 participants.