Actively Recruiting

Phase 4
Age: 18Years - 89Years
All Genders
ID03696199

A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures

Led by Lahey Clinic · Updated on 2025-11-06

70

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a long-acting local anesthetic "cocktail" compared to regional nerve block and standard care for pain control in patients undergoing surgery to fix ankle fractures. This multicenter, randomized control trial aims to improve pain management, reduce opioid use, and assess the economic impact of these pain control methods in adults with specific types of ankle fractures. The study includes three groups: one receiving standard post-operative pain control with oral narcotics, another receiving a single injection of a perioperative peripheral nerve block plus oral narcotics as needed, and the third receiving a subcutaneous injection of the local anesthetic cocktail plus oral narcotics as needed. The cocktail includes ropivicaine, clonidine, epinephrine, and saline, with the total dose adjusted based on incision size. Treatments are administered during surgery, and patients are followed for pain control and costs. Participants will undergo surgery for bimalleolar ankle fractures and then receive one of the three pain management strategies. Researchers will monitor the amount of oral narcotics taken during the first 72 hours after surgery as the primary outcome. Follow-up involves assessing pain control, patient satisfaction, and economic factors. The trial includes adults aged 18 to 89 years and excludes patients with certain fracture types, chronic opioid use, or other conditions that could affect results. Participation lasts through the post-operative period with regular assessments.

CONDITIONS

Brief Title

Randomized Controlled Trial for Ankle Fracture Pain Control

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2) with surgery planned involving medial and lateral incisions
  • Syndesmotic injuries included
  • Trimalleolar ankle fractures without planned posterior malleolus fixation included
  • Isolated injury
  • Age between 18 and 89 years
  • Ability to take standard post-operative pain regimen (gabapentin, oxycodone, acetaminophen, ibuprofen)
Not Eligible

You will not qualify if you...

  • Unifocal malleolar fractures
  • Bimalleolar fractures where only one malleolus will be fixed
  • Posterior malleolus fractures requiring fixation
  • Ineligibility for peripheral nerve block (e.g. concern for compartment syndrome)
  • Open injuries
  • Treatment with external fixation
  • Neurologic conditions that affect results (e.g. peripheral neuropathy)
  • Inability to consent
  • Chronic opioid use
  • History of opiate abuse
  • Polytrauma (additional bony, visceral, or moderate soft tissue injuries)
  • Prisoners
  • Pregnant patients
  • Non-English-speaking subjects
  • Unable to take the standard post-operative pain medications mentioned in inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo operative fixation of ankle fractures and receive one of three pain control methods: a local anesthetic cocktail injection, a perioperative nerve block, or standard oral narcotics.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 72 postoperative hours

Participants are monitored for pain control effectiveness and use of oral narcotics during the first 72 hours after surgery.

Approximately 3 post-operative visits

Trial Site Locations

Total: 1 location

1

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

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Research Team

E

Eric Swart, MD

J

Jillian Kazley, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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