Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures
Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Anette B Christensen, MD
- Phone Number: +45 24 66 63 32
- Email: anettebrojensen@gmail.com
Study Contact Backup
- Name: Christoffer G Sølling, MD, PhD
- Phone Number: + 45 78 44 52 12
- Email: chrsoell@rm.dk
Study Locations
-
-
-
Viborg, Denmark, DK-8800
- Dept. Anesthesia and Intensive Care, Viborg Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria
- Presence of a closed distal forearm fracture in need of a closed reduction
- Age > 18 years
- Legally competent
Exclusion criteria
- Inability to give informed consent
- Allergy or intolerance towards local anaesthetics
- Infection or burns at either injection site
- Multi trauma (defined as other fractures or significant injuries)
- Known pregnancy
- Participation in other studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Patients with distal forearm fractures randomized to Hematoma Block.
|
Conventional local anesthetic method using hematoma block
|
|
Active Comparator: Intervention Group
Patients with distal forearm fractures randomized to Ultrasound guided nerve block
|
Ultrasound guided nerve blocks of the radial and median nerves
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 8 hours from admission
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Within 8 hours from admission
|
|
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)
|
Within 8 hours from admission
|
|
Time spent on reduction
Time Frame: Within 8 hours from admission
|
Time stamp start; when reduction begins.
Time stamp end; when casting is complete
|
Within 8 hours from admission
|
|
Secondary fracture dislocation
Time Frame: Records obtained 2 months after primary treatment
|
Measured by the need for surgical stabilization
|
Records obtained 2 months after primary treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Anette B Christensen, MD, Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 030021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fracture Closed of Lower End of Forearm, Unspecified
-
NCT07552766Not yet recruitingFracture Forearm | Fracture Fixation, Internal | Fracture Elbow | Fracture Arm | Fracture Distal Radius | Fracture Fixation | Fracture Closed of Lower End of Forearm, Unspecified
-
NCT02312128CompletedEarly Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled TrailClosed Fracture of Lower End of Radius and Ulna
-
NCT06209242CompletedClosed Fracture of Lower End of Radius
-
NCT01518179CompletedColles' Fracture | Distal Radius Fractures | Fracture of Lower End of Radius | Smith's Fracture
-
NCT06304649Not yet recruitingFractures, Closed | Fractures | Fracture | Ulna Fractures | Radius Distal Fracture | Radius; Fracture, Lower or Distal End | Fractures Bone
-
NCT03724773WithdrawnClosed Fracture of Shaft of Ulna | Closed Fracture of Shaft of Radius
-
NCT06276062RecruitingFracture of Distal End of Radius | Trauma Injury of Upper Extremity Forearm Multiple
-
NCT03533634CompletedClosed Fracture of Shaft of Clavicle
-
NCT03689335CompletedClosed Fracture of Shaft of Humerus
-
NCT01363518CompletedClosed Fracture of Shaft of Humerus
Clinical Trials on Hematoma Block
-
NCT07183904CompletedAcute Distal Radius Fracture | Displaced Distal Radius Fracture
-
NCT00775554Withdrawn
-
NCT07268547Enrolling by invitation
-
NCT06193915RecruitingFracture Dislocation | Distal Radius Fractures | Dislocated Wrist | Dislocated Radius
-
NCT07625787CompletedDistal Radius Fracture | Brachial Plexus Block | Hematoma Block
-
NCT05996315CompletedAdults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department
-
NCT05674383CompletedDistal Radius Fracture | Forearm Fracture
-
NCT04647162RecruitingA Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage (STIPE)Cerebrovascular Disorders | Surgery | Primary | Pontine Hemorrhage
-
NCT07144423RecruitingChronic Subdural Hematoma
-
NCT04805177CompletedIntracerebral Hemorrhage (ICH)