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Randomized Controlled Trial for Ankle Fracture Pain Control

NCT03696199 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-11-06

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Regional Anesthesia

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

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Eric Swart, MD · Lahey Hospital & Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2026-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696199 on ClinicalTrials.gov