Aspiration for Pain Relief Following Ankle Fracture

NCT01484535 | Completed

• 1 other identifier: 11-004187
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Fracture

Outcome Measures

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.

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Ankle aspiration

OTHER

ankle aspiration

Procedure: Ankle Aspiration

placebo procedure

PLACEBO COMPARATOR

placebo procedure

Procedure: Ankle aspiration Standard Anterolateral

Interventions

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

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.

placebo procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen Sems, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

US (1)