Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

NCT03376100 | Completed DMC

• 1 other identifier: 030021
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture Closed of Lower End of Forearm, Unspecified

Outcome Measures

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.

  Within 8 hours from admission

Secondary Outcomes (4)

• Pain, during reduction

  Within 8 hours from admission

• Pain, when local anaesthetic is injected

  Within 8 hours from admission

• Time spent on reduction

  Within 8 hours from admission

• Secondary fracture dislocation

  Records obtained 2 months after primary treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients with distal forearm fractures randomized to Hematoma Block.

Procedure: Hematoma Block

Intervention Group

ACTIVE COMPARATOR

Patients with distal forearm fractures randomized to Ultrasound guided nerve block

Procedure: Ultrasound guided nerve blocks

Interventions

Ultrasound guided nerve blocks PROCEDURE

Ultrasound guided nerve blocks of the radial and median nerves

Intervention Group

Hematoma Block PROCEDURE

Conventional local anesthetic method using hematoma block

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regionshospitalet Viborg, Skive: lead
• Aalborg University Hospital: collaborator
• Randers Regional Hospital: collaborator
• Herning Hospital: collaborator

Study Sites (1)

Dept. Anesthesia and Intensive Care, Viborg Regional Hospital

Viborg, DK-8800, Denmark

Location

Study Officials

• Anette B Christensen, MD

  Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Head of Research, MD, PhD

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: December 1, 2017
• Primary Completion: November 13, 2019
• Study Completion: May 20, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

DK (1)