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Fracture Closed of Lower End of Forearm, UnspecifiedNCT03376100

Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

A study testing Ultrasound guided nerve blocks and Hematoma Block in people with Fracture Closed of Lower End of Forearm, Unspecified, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound guided nerve blocks and Hematoma Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteDenmark
Study dates
1 Dec 2017to 20 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of a closed distal forearm fracture in need of a closed reduction
  • Age > 18 years
  • Legally competent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Dept. Anesthesia and Intensive Care, Viborg Regional Hospital

    Viborg, DK-8800

Other trials in Denmark

About this study

Official title: Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.

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.

Read the 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.

Being tested
Ultrasound guided nerve blocks, Hematoma Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided nerve blocksProcedure or surgery

    Ultrasound guided nerve blocks of the radial and median nerves

  • Hematoma BlockProcedure or surgery

    Conventional local anesthetic method using hematoma block

Study groups in NCT03376100
Study groupRoleWhat they receive
Control GroupActive comparatorPatients with distal forearm fractures randomized to Hematoma Block.
Receives: Procedure: Hematoma Block
Intervention GroupActive comparatorPatients with distal forearm fractures randomized to Ultrasound guided nerve block
Receives: Procedure: Ultrasound guided nerve blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 8 hours from admission

Secondary outcomes (4)
  1. 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)

    Measured: Within 8 hours from admission

  2. 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)

    Measured: Within 8 hours from admission

  3. Time spent on reduction

    Time stamp start; when reduction begins. Time stamp end; when casting is complete

    Measured: Within 8 hours from admission

  4. Secondary fracture dislocation

    Measured by the need for surgical stabilization

    Measured: Records obtained 2 months after primary treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start1 Dec 2017
  3. Primary completion13 Nov 2019
  4. Study completion20 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376100
Sponsor's protocol ID
030021
Status last verified
Nov 2024
First submitted
6 Dec 2017
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided nerve blocks and Hematoma Block in people with Fracture Closed of Lower End of Forearm, Unspecified, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction satisfaction (time frame: Within 8 hours from admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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