Aspiration for Pain Relief Following Ankle Fracture

Ankle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484535
• Other study ID #: 11-004187
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: July 16, 2015
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No