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.

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.

Study Overview

• Status: Unknown
• Conditions: Fracture Closed of Lower End of Forearm, Unspecified
• Intervention / Treatment: Procedure: Hematoma Block; Procedure: Ultrasound guided nerve blocks

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: Interventional
• Enrollment (Anticipated): 268
• Phase: Not Applicable

Contacts and Locations

• 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

• Denmark
  • Viborg, Denmark, DK-8800
    • Recruiting
    • Dept. Anesthesia and Intensive Care, Viborg Regional Hospital
    • Contact: Anette Bro, MD; Phone Number: +45 24 66 63 32; Email: anettebrojensen@gmail.com
    • Contact: Christoffer Sølling, MD, PhD; Phone Number: +45 78445212

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Patients with distal forearm fractures randomized to Hematoma Block.	Procedure: Hematoma Block; Conventional local anesthetic method using hematoma block
Active Comparator: Intervention Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Within 8 hours from admission
Time spent on reduction	Time stamp start; when reduction begins. Time stamp end; when casting is complete	Within 8 hours from admission
Secondary fracture dislocation	Measured by the need for surgical stabilization	Records obtained 2 months after primary treatment

Collaborators and Investigators

• Sponsor: Regionshospitalet Viborg, Skive
• Collaborators: Herning Hospital; Aalborg University Hospital; Randers Regional Hospital
• Investigators: Principal Investigator: Anette B Christensen, MD, Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 030021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No