Recruiting

Ankle Fracture Pain

Sponsor:

Lahey Clinic

Code:

NCT03696199

Conditions

Ankle Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Long-Acting Local Anesthesia

Regional Anesthesia

Study Details

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.

Conditions

Ankle Fractures

Study ID

NCT03696199

Start date

Sep 1, 2020

Status verified date

Nov, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Traditional Pain Control Care

Standard of care post-operative pain control with oral narcotics

experimental: Regional Anesthesia

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

experimental: Long-Acting Local Anesthesia

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

Interventions

Long-Acting Local Anesthesia

The cocktail consists of:

  • 0.5% Ropivicaine, 24.6 mL
  • Clonidine 100 mcg/mL, 0.4mL
  • Epinephrine 1mg/mL, 0.5mL
  • Saline to total volume of 50 mL (24.5mL of saline)

The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.

Regional Anesthesia

0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided

Primary outcome measure

  • Oral Narcotics / Morphine Milligram Equivalents (MME) given [ Time Frame: 72 postoperative hours ]

Central Contacts and Locations

Central contacts

Eric Swart, MD

781-744-2629eric.f.swart@lahey.org

Jillian Kazley, MD

781-744-2629jillian.kazley@lahey.org

Locations

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Eric Swart, MD

781-744-2629

More Information

Sponsor

Lahey Clinic

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lahey Clinic on 2025-11-06.