Aspiration for Pain Relief Following Ankle Fracture

Not Applicable

Completed

• Conditions: Ankle Fracture
• Interventions: Procedure: Ankle Aspiration; Procedure: Ankle aspiration Standard Anterolateral

• Registration Number: NCT01484535
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Primary Completion: 2014-02
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle aspiration	Ankle Aspiration	ankle aspiration
placebo procedure	Ankle aspiration Standard Anterolateral	placebo procedure

Primary Outcome Measures

Name	Time	Method
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.	6 months	Total amount of pain medication used in the first 72 hours from time of initial evaluation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States