Aspiration for Pain Relief Following Ankle Fracture

Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial

This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.

Study Overview

• Status: Completed
• Conditions: Ankle Fracture
• Intervention / Treatment: Procedure: Ankle Aspiration; Procedure: Ankle aspiration Standard Anterolateral

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• AO/OTA fracture classification 44
• Closed fracture
• Injury within 24 hours of presentation
• Skeletally mature
• Able to provide consent to participate in study

Exclusion Criteria:

• Any concomitant injuries affecting Numerical Rating Scale
• Soft tissue wounds at aspiration sites that compromise ability to aspirate
• Patient not able to complete pain medication log
• Patient not able to participate in follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ankle aspiration; ankle aspiration	Procedure: Ankle Aspiration; Ankle aspiration will be performed through either a standard anterolateral or anteromedial approach, depending on the conditions of the soft tissue. The anterolateral approach will be the preferred method due to the higher reproducibility of intra-articular needle placement. The anteromedial approach will be reserved for patients whose soft tissues over the anterolateral portal are compromised. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18 gauge needle will be introduced into the ankle joint and a syringe will be used to aspirate the ankle until no more hemarthrosis is able to be removed. The amount of hemarthrosis aspirated will be recorded. Following the procedure, care will continue as per standard of care.
Placebo Comparator: placebo procedure	Procedure: Ankle aspiration Standard Anterolateral; Placebo ankle aspiration will be performed through a standard anterolateral. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18-gauge needle will be introduced into the skin. The needle will be held in the skin for 5-10 seconds in an effort to simulate the pain and time-lag experienced with aspiration. The needle will not pass the fascia or ankle joint capsule. Following the procedure, care will continue as per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.	Total amount of pain medication used in the first 72 hours from time of initial evaluation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.	NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stephen Sems, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 11-004187