An interventional study of Ultrasound guided nerve blocks and Hematoma Block in Fracture Closed of Lower End of Forearm, Unspecified, sponsored by Regionshospitalet Viborg, Skive. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Regionshospitalet Viborg, Skive · Not applicable, Interventional, and Treatment
Randomized controlled trial comparing the standard haematoma block used for reduction of distal forearm fractures in the Emergency Department with ultrasound guided nerveblocks. 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 distal forearm fracture types compared to the standard haematoma block.
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 268 is above the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →Regionshospitalet Viborg, Skive is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with distal forearm fractures randomized to Hematoma Block.
Procedure: Hematoma Block
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
Conventional local anesthetic method using hematoma block
Reduction satisfaction
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.
Time frame: Within 8 hours from admission
Pain, during reduction
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 frame: Within 8 hours from admission
Pain, when local anaesthetic is injected
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 frame: Within 8 hours from admission
Time spent on reduction
Time stamp start; when reduction begins. Time stamp end; when casting is complete
Time frame: Within 8 hours from admission
Secondary fracture dislocation
Measured by the need for surgical stabilization
Time frame: Records obtained 2 months after primary treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Nov 2019, 23 months.
Of 14 interventional studies with no phase under Fractures, Closed, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 49. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Regionshospitalet Viborg, Skive