Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures
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|ClinicalTrials.gov Identifier: NCT03376100|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fracture Closed of Lower End of Forearm, Unspecified||Procedure: Ultrasound guided nerve blocks Procedure: Hematoma Block||Not Applicable|
Multicenter randomized controlled trial comparing the standard hematoma block as the local anaesthetic procedure for reduction of distal forearm fracture with ultrasound guided radial and median nerve blocks.
Among all dislocated fractures of the distal forearm only the true Colles' fracture can potentially be treated adequately with a closed reduction and a cast, while the other fracture types are unstable by definition and require surgical stabilization. Most dislocated forearm fractures, however, require a primary reduction and this procedure requires the patient to be relieved of pain and the muscle traction on the fracture to be minimal. The conventional local anaesthetic procedure used in Denmark is the hematoma block where the local anaesthetic agent is injected directly in the fracture. This is done using either a blind technique or with the aid of X-ray to visualize the fracture line. The radial and median nerves supply periosteal innervation for the radius and the ulna as well as muscular innervation for the majority of muscles in the forearm and wrist. Blocking these nerves at the level of the cubital fossa should relieve pain and minimize muscular traction when performing closed reductions on distal forearm fractures.
The investigators hypothesize that ultrasound guided blocking of the radial and median nerves will improve fracture reduction satisfaction for the true Colles' fractures and improve analgesia for reduction of all fracture types compared to the standard haematoma block.
Patients eligible for screening for inclusion are identified in the Emergency Department (ED) at all recruitment sites upon primary contact. When an X-ray has revealed the relevant fracture, the ED-staff will call the available anaesthesiologist or anaesthesiologist trainee who will perform the inclusion process and randomisation. Participants will be randomized in either the intervention or the control group using the online randomization tool Research Electronic Data Capture (REDCap, Aarhus University, Denmark). In both groups, the reduction process will begin 10 minutes after the block has been performed. The technique for the actual reduction may vary amongst physicians. To best reflect the clinical practices and to avoid the risk of an insufficient reduction due to the physician being forced to comply to a technique unfamiliar to him, no further standardisation will be made in this regard. Following casting of the fracture a control X-ray will be performed and subsequently evaluated independently by two skilled orthopaedic surgeons to establish if the reduction was satisfactory. In case of disputes a third orthopaedic surgeon will evaluate the X-ray and make a final ruling. The fracture will be deemed satisfactory using a binary outcome measure (yes/no) if all the following requirements set by the National Clinical Guideline for Treatment of Distal Radius Fractures are met.
Binary data, including primary endpoint will be analysed using chi squared test. For normally distributed measurements the differences between groups will be compared using Student´s t-test. Variables considered not to be normally distributed will be analysed by Mann-Whitney´s U-test. Two-tailed P-values < 0.05 will be considered statistically significant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||November 30, 2020|
Active Comparator: Control Group
Patients with distal forearm fractures randomized to Hematoma Block.
Procedure: Hematoma Block
Conventional local anesthetic method using hematoma block
Active Comparator: Intervention Group
Patients with distal forearm fractures randomized to Ultrasound guided nerve block
Procedure: Ultrasound guided nerve blocks
Ultrasound guided nerve blocks of the radial and median nerves
- Reduction satisfaction [ Time Frame: Within 8 hours from admission ]Based on objective X-ray measures according to the Danish National Guideline for Treatment of Distal Forearm Fractures. The primary outcome applies for the true Colles' fractures only.
- Pain, during reduction [ Time Frame: Within 8 hours from admission ]Pain score using an 11-step numeric rating scale (0-1-2-3-4-5-6-7-8-9-10, with 0 being no pain and 10 being worst pain imanigable)
- Pain, when local anaesthetic is injected [ Time Frame: Within 8 hours from admission ]Pain score using an 11-step numeric rating scale (0-1-2-3-4-5-6-7-8-9-10, with 0 being no pain and 10 being worst pain imanigable)
- Time spent on reduction [ Time Frame: Within 8 hours from admission ]Time stamp start; when reduction begins. Time stamp end; when casting is complete
- Secondary fracture dislocation [ Time Frame: Records obtained 2 months after primary treatment ]Measured by the need for surgical stabilization
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): NCT03376100
|Contact: Anette B Christensen, MD||+45 24 66 63 firstname.lastname@example.org|
|Contact: Christoffer G Sølling, MD, PhD||+ 45 78 44 52 email@example.com|
|Dept. Anesthesia and Intensive Care, Viborg Regional Hospital||Recruiting|
|Viborg, Denmark, DK-8800|
|Contact: Anette Bro, MD +45 24 66 63 32 firstname.lastname@example.org|
|Contact: Christoffer Sølling, MD, PhD +45 78445212|
|Principal Investigator:||Anette B Christensen, MD||Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg|