Clinical Trial: Sonographic Assessment of Reduction in Colles' Fracture

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Sonographic Assessment of Reduction in Colles' Fracture

Brief Summary:

Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. This study will assess whether ultrasound can be used immediately after the manipulation to check the position, before the plaster cast is applied. This would then be followed by an xray as normal.

The aim is to assess the feasibility of a full study to determine which method is faster, causes less pain, and also to assess if either approach reduces the need for repeat attempts at manipulation and surgical repair.


Detailed Summary:

Fractures of the distal radius are a frequent cause for presentation to United Kingdom (UK) Emergency Departments, and the Colles' fracture is the most commonly encountered type. These injuries frequently occur in isolation, or associated with only minor injuries, and reduction of displaced fractures is typically performed by Emergency Physicians at the time of first attendance to the hospital.

The usually sequence of events is clinical examination, x-ray imaging to confirm the fracture, then the reduction is performed with appropriate analgesia or anaesthesia, the arm placed in a plaster backslab, and repeat imaging is taken to confirm adequacy of reduction. If the reduction is not satisfactory, repeat manipulation is required.

Haematoma block and Biers block permit x-ray imaging of the manipulated wrist while the anaesthetic action is still effective, permitting re-manipulation without further administration of local anaesthetic. Sedation is usually kept to as short a time as possible, and is not usually maintained while imaging is performed. There is usually some degree of delay while x-rays are taken and made available for viewing, and this wait prolongs the procedure for the patient and the treating clinician. In addition, Biers block cannot be tolerated for long by most patients, so any delay makes it less likely that a re-manipulation can be achieved within the time the patient can tolerate. If a patient has been sedated, a re-manipulation will require a further sedative (or alternative) procedure with the concomitant risks that entails.

Ideally, imaging would be performed rapidly, immediately at the end of the manipulation, prior to application of plaster, allowing confirmation of the reduction or immediate re-manipulation if necessary. This description of imaging p
Sponsor: Simon Richards

Current Primary Outcome: The total inflation time of the tourniquet used during the Biers Block [ Time Frame: The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing ]

The total inflation time of tourniquet used for Biers block


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The total number of manipulations required per patient within the Emergency Department [ Time Frame: The duration of the manipulation procedure; complete within 30 minutes of procedure commencing ]
    Number of attempts at manipulation within Emergency Department
  • Does the use of ultrasound reduce the need for surgical reduction? [ Time Frame: Four weeks from visit ]
    Need for surgical reduction/fixation
  • Does the use of ultrasound reduce the time spent within the Emergency Department? [ Time Frame: End of initial ED visit, within twelve hours of initial arrival to the hospital ]
    Total time spent within Emergency Department
  • Does the use of ultrasound reduce the pain score during the reduction? [ Time Frame: End of procedure - within 30 minutes of the procedure commencing ]
    Patient reported pain score at the end of the fracture reduction
  • Does the use of ultrasound increase the patient satisfaction? [ Time Frame: Four weeks after visit ]
    Patient reported satisfaction with reduction of fracture


Original Secondary Outcome: Same as current

Information By: Teesside University

Dates:
Date Received: January 25, 2015
Date Started: January 2015
Date Completion: July 2016
Last Updated: January 28, 2015
Last Verified: January 2015