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Aspiration for Pain Relief Following Ankle Fracture

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01484535
Enrollment
130
Registered
2011-12-02
Start date
2011-09-30
Completion date
2015-06-30
Last updated
2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture

Brief summary

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

Interventions

PROCEDUREAnkle 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.

PROCEDUREAnkle 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsTotal amount of pain medication used in the first 72 hours from time of initial evaluation.

Secondary

MeasureTime frameDescription
Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.6 monthsNRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026