Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

NCT ID: NCT03376100

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2024-05-20

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.

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.

Conditions

Fracture Closed of Lower End of Forearm, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients with distal forearm fractures randomized to Hematoma Block.

Group Type: ACTIVE_COMPARATOR

Hematoma Block

Intervention Type: PROCEDURE

Conventional local anesthetic method using hematoma block

Intervention Group

Patients with distal forearm fractures randomized to Ultrasound guided nerve block

Group Type: ACTIVE_COMPARATOR

Ultrasound guided nerve blocks

Intervention Type: PROCEDURE

Ultrasound guided nerve blocks of the radial and median nerves

Interventions

Ultrasound guided nerve blocks

Ultrasound guided nerve blocks of the radial and median nerves

Intervention Type: PROCEDURE

Hematoma Block

Conventional local anesthetic method using hematoma block

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Randers Regional Hospital

OTHER

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: collaborator

Regionshospitalet Viborg, Skive

OTHER

Sponsor Role: lead

Responsible Party

Christoffer Grant Sølling

Consultant, Head of Research, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anette B Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg

Locations

Dept. Anesthesia and Intensive Care, Viborg Regional Hospital

Viborg, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

030021

Identifier Type: -

Identifier Source: org_study_id