Aspiration for Pain Relief Following Ankle Fracture
|ClinicalTrials.gov Identifier: NCT01484535|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : July 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fracture||Procedure: Ankle Aspiration Procedure: Ankle aspiration Standard Anterolateral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2015|
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.
Placebo Comparator: placebo procedure
Procedure: 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484535
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Stephen Sems, MD||Mayo Clinic|