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Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

Primary Purpose

Fracture Closed of Lower End of Forearm, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ultrasound guided nerve blocks
Hematoma Block
Sponsored by
Regionshospitalet Viborg, Skive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Closed of Lower End of Forearm, Unspecified

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. Anesthesia and Intensive Care, Viborg Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Intervention Group

Arm Description

Patients with distal forearm fractures randomized to Hematoma Block.

Patients with distal forearm fractures randomized to Ultrasound guided nerve block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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 spent on reduction
Time stamp start; when reduction begins. Time stamp end; when casting is complete
Secondary fracture dislocation
Measured by the need for surgical stabilization

Full Information

First Posted
December 6, 2017
Last Updated
May 16, 2018
Sponsor
Regionshospitalet Viborg, Skive
Collaborators
Aalborg University Hospital, Randers Regional Hospital, Herning Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03376100
Brief Title
Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures
Official Title
Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Viborg, Skive
Collaborators
Aalborg University Hospital, Randers Regional Hospital, Herning Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Closed of Lower End of Forearm, Unspecified

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients with distal forearm fractures randomized to Hematoma Block.
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Patients with distal forearm fractures randomized to Ultrasound guided nerve block
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided nerve blocks
Intervention Description
Ultrasound guided nerve blocks of the radial and median nerves
Intervention Type
Procedure
Intervention Name(s)
Hematoma Block
Intervention Description
Conventional local anesthetic method using hematoma block
Primary Outcome Measure Information:
Title
Reduction satisfaction
Description
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 Outcome Measure Information:
Title
Pain, during reduction
Description
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
Title
Pain, when local anaesthetic is injected
Description
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
Title
Time spent on reduction
Description
Time stamp start; when reduction begins. Time stamp end; when casting is complete
Time Frame
Within 8 hours from admission
Title
Secondary fracture dislocation
Description
Measured by the need for surgical stabilization
Time Frame
Records obtained 2 months after primary treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anette B Christensen, MD
Phone
+45 24 66 63 32
Email
anettebrojensen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christoffer G Sølling, MD, PhD
Phone
+ 45 78 44 52 12
Email
chrsoell@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette B Christensen, MD
Organizational Affiliation
Dept. Anesthesiology-Intensive Care Medicine, Reional Hospital Viborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Anesthesia and Intensive Care, Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Bro, MD
Phone
+45 24 66 63 32
Email
anettebrojensen@gmail.com
First Name & Middle Initial & Last Name & Degree
Christoffer Sølling, MD, PhD
Phone
+45 78445212

12. IPD Sharing Statement

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Distal Nerve Blocks for Closed Reduction of Distal Forearm Fractures

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