Skip to main content
OpenTrials
Completed

NCT Number: NCT01484535

Aspiration for Pain Relief Following Ankle Fracture

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Fracture Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Aspiration

Procedure

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.

Ankle aspiration Standard Anterolateral

Procedure

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.

Primary outcomes

  1. 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.

    Time frame: 6 months

    Total amount of pain medication used in the first 72 hours from time of initial evaluation.

Secondary outcomes

  1. Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.

    Time frame: 6 months

    NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 2, 2011
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.