ClinicalTrials.gg
CompletedNCT03376100Updated Nov 8, 2024

Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

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

Phase
Not applicable
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Fracture Closed of Lower End of Forearm, Unspecified

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03

In context

Fractures, Closed

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 →

Lead sponsor

Regionshospitalet Viborg, Skive is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

  • Inability to give
  • 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
Terms in these criteria, in plain language(1)

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.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
268 participants (actual)

Study arms

  • Active comparator
    Control Group

    Patients with distal forearm fractures randomized to Hematoma Block.

    Procedure: Hematoma Block

  • Active comparator
    Intervention Group

    Patients with distal forearm fractures randomized to Ultrasound guided nerve block

    Procedure: Ultrasound guided nerve blocks

Interventions

  • ProcedureUltrasound guided nerve blocks

    Ultrasound guided nerve blocks of the radial and median nerves

  • ProcedureHematoma Block

    Conventional local anesthetic method using hematoma block

06

What researchers measure

Primary outcomes

  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.

    Time frame: Within 8 hours from admission

Secondary outcomes

  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)

    Time frame: 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)

    Time frame: Within 8 hours from admission

  3. Time spent on reduction

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

    Time frame: Within 8 hours from admission

  4. Secondary fracture dislocation

    Measured by the need for surgical stabilization

    Time frame: Records obtained 2 months after primary treatment

07

Study locations

1 site
  • Dept. Anesthesia and Intensive Care, Viborg Regional Hospital
    Viborg, DK-8800, Denmark
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Dec 6, 2017
First posted
Dec 18, 2017
StartActual
Dec 1, 2017
Primary completionActual
Nov 13, 2019
CompletionActual
May 20, 2024
Last update
Nov 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03376100
Lead sponsor
Regionshospitalet Viborg, Skive
Collaborators
Aalborg University Hospital, Randers Regional Hospital, Herning Hospital
Responsible party
Christoffer Grant Sølling (Consultant, Head of Research, MD, PhD, Regionshospitalet Viborg, Skive) — Principal investigator
First posted
Dec 18, 2017
Start date
Dec 1, 2017
Primary completion
Nov 13, 2019
Completion
May 20, 2024
Last update
Nov 8, 2024

Study contacts

Anette B Christensen, MD
principal investigator · Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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