Sonographic Assessment of Reduction in Colles' Fracture (SONAR)
Primary Purpose
Colles' Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound imaging
Bedside x-ray
Sponsored by
About this trial
This is an interventional treatment trial for Colles' Fracture focused on measuring Colles' Fracture, ultrasonography
Eligibility Criteria
Inclusion Criteria:
- Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)
Exclusion Criteria:
- Age under 16
- Contraindication to Biers block
- Unable to give informed consent
- Multiple injuries
- Open fracture
- Prisoners
Sites / Locations
- Royal Preston HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Ultrasound
Arm Description
Assessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block)
Assessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block)
Outcomes
Primary Outcome Measures
The total inflation time of the tourniquet used during the Biers Block
The total inflation time of tourniquet used for Biers block
Secondary Outcome Measures
The total number of manipulations required per patient within the Emergency Department
Number of attempts at manipulation within Emergency Department
Does the use of ultrasound reduce the need for surgical reduction?
Need for surgical reduction/fixation
Does the use of ultrasound reduce the time spent within the Emergency Department?
Total time spent within Emergency Department
Does the use of ultrasound reduce the pain score during the reduction?
Patient reported pain score at the end of the fracture reduction
Does the use of ultrasound increase the patient satisfaction?
Patient reported satisfaction with reduction of fracture
Full Information
NCT ID
NCT02353065
First Posted
January 25, 2015
Last Updated
January 28, 2015
Sponsor
Simon Richards
Collaborators
Lancashire Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02353065
Brief Title
Sonographic Assessment of Reduction in Colles' Fracture
Acronym
SONAR
Official Title
Sonographic Assessment of Reduction in Colles' Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon Richards
Collaborators
Lancashire Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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 provided at the point of care by the treating clinician, aimed at answering a clearly defined question ('is this an adequate reduction?') matches the description of focussed emergency ultrasound in other applications. If ultrasound could be used to assess fracture reduction, it would have potential to save clinician time, patient time and discomfort, and reduced the need for repeated manipulations and surgical repair.
This study intends to assess the feasibility of a full trial of efficacy comparing ultrasound with x-ray to guide the reduction of these fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture
Keywords
Colles' Fracture, ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Assessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block)
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Assessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound imaging
Intervention Description
Point of care ultrasound of fracture site during and post-reduction
Intervention Type
Radiation
Intervention Name(s)
Bedside x-ray
Intervention Description
Portable x-ray of fracture post-reduction
Primary Outcome Measure Information:
Title
The total inflation time of the tourniquet used during the Biers Block
Description
The total inflation time of tourniquet used for Biers block
Time Frame
The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing
Secondary Outcome Measure Information:
Title
The total number of manipulations required per patient within the Emergency Department
Description
Number of attempts at manipulation within Emergency Department
Time Frame
The duration of the manipulation procedure; complete within 30 minutes of procedure commencing
Title
Does the use of ultrasound reduce the need for surgical reduction?
Description
Need for surgical reduction/fixation
Time Frame
Four weeks from visit
Title
Does the use of ultrasound reduce the time spent within the Emergency Department?
Description
Total time spent within Emergency Department
Time Frame
End of initial ED visit, within twelve hours of initial arrival to the hospital
Title
Does the use of ultrasound reduce the pain score during the reduction?
Description
Patient reported pain score at the end of the fracture reduction
Time Frame
End of procedure - within 30 minutes of the procedure commencing
Title
Does the use of ultrasound increase the patient satisfaction?
Description
Patient reported satisfaction with reduction of fracture
Time Frame
Four weeks after visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)
Exclusion Criteria:
Age under 16
Contraindication to Biers block
Unable to give informed consent
Multiple injuries
Open fracture
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Richards
Phone
+44 1642 342589
Email
s.richards@tees.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Stewart
Phone
+44 7812 203011
Email
michael.stewart@lthtr.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Richards
Organizational Affiliation
Teesside University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Preston Hospital
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Sonographic Assessment of Reduction in Colles' Fracture
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