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Ultrasound Guided Axillary Nerve Block Compared to Hematoma Block in Patients With Closed Reposition of Distal Forearm Fractures

Primary Purpose

Distal Radius Fracture, Forearm Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Axillary plexus nerve block
Fracture hematoma block
Sponsored by
Medical Centre Leeuwarden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients in the ED with a X-ray confirmed dislocated distal forearm fracture, defined as fracture < 3cm within the radiocarpal joint with an abnormal anatomic position (dorsal angulation >10°, volar angulation >20°, radioulnar inclination <15°, >5mm radial collapse or intra-articular incongruence >2mm. ≥ 16 years of age Patients who have adequate knowledge and understanding of the Dutch language Exclusion Criteria: 'Open' fractures requiring surgery Multi-trauma patients Abnormal neurovascular examination requiring immediate reposition or surgery Pre-existent osteosynthesis material in situ on the present fracture site. Skin injury, local infection or recent burns hindering the use of ultrasound. Allergy for local anaesthetics Inability to give informed consent (cognitive impairments, no good understanding of the Dutch or English language) Severe coagulopathy (i.e. severe thrombocytopenia, haemophilia.). Usage of anticoagulation is not an contra-indication, since any bleeding complication has few adverse consequences(20). High risk on compartment syndrome (in consultation with surgery department).

Sites / Locations

  • Medisch centrum LeeuwardenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

The intervention group will receive an axillary plexus nerve block as pain reduction before the fracture repositioning.

The control group will receive a fracture hematoma block as pain reduction before the fracture repositioning.

Outcomes

Primary Outcome Measures

Pain score
The primary outcome is pain measured on a pain score using a 11-point NRS (0-10) during closed reposition of the dislocated distal forearm fracture in both groups

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
October 23, 2023
Sponsor
Medical Centre Leeuwarden
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1. Study Identification

Unique Protocol Identification Number
NCT05674383
Brief Title
Ultrasound Guided Axillary Nerve Block Compared to Hematoma Block in Patients With Closed Reposition of Distal Forearm Fractures
Official Title
Ultrasound-guided Axillary Nerve Block Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Centre Leeuwarden

4. Oversight

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

5. Study Description

Brief Summary
Rationale: For distal forearm fractures the investigators propose an anaesthetic method using an ultrasound guided axillary nerve block (ANB, an established technique) for pain reduction during reposition dislocated fractures. Nowadays a fracture hematoma block (FHB) is common practice, but is suboptimal due to variability between performing physicians and is often experienced as a painful procedure. The investigators want to investigate if ANB is an effective, safe and efficient option in pain reduction in patients of an ED (emergency department) population with a distal forearm fracture. Objective: To compare ultrasound-guided ANB with FHB for analgesia during reposition of non-operatively treated forearm fractures Study design: A randomized controlled trial. Study population: Patients ≥ 16 years of age with a closed, isolated and displaced distal forearm fracture requiring manipulative reposition. Intervention (if applicable): The intervention group will receive an ANB on the ipsilateral arm of the fracture. The control group will get a FHB. Main study parameters/endpoints: The primary outcome is pain score on a 11-point NRS (numeric rating scale) (0-10) during closed reposition of the dislocated distal forearm fracture in both groups. Main endpoint of this study is achieving a reduction of at least 2 points between both groups. This is considered as clinical relevant. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the research group are believed to have less pain and more comfort during reposition of the dislocated fracture. The investigators expect no other or more complications compared to standard care since the known complications are the same for both infiltrative anaesthetic interventions and are rare. Moreover, both procedures are common practice, therefore potential complications will be taken care of properly. The investigators expect there is no prolonged length of stay in the ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Forearm Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will receive an axillary plexus nerve block as pain reduction before the fracture repositioning.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive a fracture hematoma block as pain reduction before the fracture repositioning.
Intervention Type
Procedure
Intervention Name(s)
Axillary plexus nerve block
Intervention Description
Axillary plexus nerve block: an ultrasound-guided axillary plexus nerve block with a single injection of lidocaine 1%.
Intervention Type
Procedure
Intervention Name(s)
Fracture hematoma block
Intervention Description
Fracture hematoma block: a blinded single injection into the fracture with lidocaine 1%.
Primary Outcome Measure Information:
Title
Pain score
Description
The primary outcome is pain measured on a pain score using a 11-point NRS (0-10) during closed reposition of the dislocated distal forearm fracture in both groups
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients in the ED with a X-ray confirmed dislocated distal forearm fracture, defined as fracture < 3cm within the radiocarpal joint with an abnormal anatomic position (dorsal angulation >10°, volar angulation >20°, radioulnar inclination <15°, >5mm radial collapse or intra-articular incongruence >2mm. ≥ 16 years of age Patients who have adequate knowledge and understanding of the Dutch language Exclusion Criteria: 'Open' fractures requiring surgery Multi-trauma patients Abnormal neurovascular examination requiring immediate reposition or surgery Pre-existent osteosynthesis material in situ on the present fracture site. Skin injury, local infection or recent burns hindering the use of ultrasound. Allergy for local anaesthetics Inability to give informed consent (cognitive impairments, no good understanding of the Dutch or English language) Severe coagulopathy (i.e. severe thrombocytopenia, haemophilia.). Usage of anticoagulation is not an contra-indication, since any bleeding complication has few adverse consequences(20). High risk on compartment syndrome (in consultation with surgery department).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bram Rook, MSc
Phone
+31612394407
Email
bram.rook@mcl.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heleen Lameijer, Dr
Organizational Affiliation
Heleen.Lameijer1@mcl.nl
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch centrum Leeuwarden
City
Leeuwarden
State/Province
Friesland
ZIP/Postal Code
8934AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bram Rook, MSc
Email
bram.rook@mcl.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound Guided Axillary Nerve Block Compared to Hematoma Block in Patients With Closed Reposition of Distal Forearm Fractures

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