Randomized Controlled Trial for Ankle Fracture Pain Control

Part of paid clinical trials in Burlington, Massachusetts.

Sponsor
Lahey Clinic
Study ID
NCT03696199
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Ankle Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Long-Acting Local Anesthesia — DRUG
    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 — DRUG
    0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805
Eric Swart, MD
781-744-2629

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By research site
Lahey Hospital & Medical Center· Burlington, MA

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