NCT05674383

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

Completed NA Last updated 29 November 2023

What this trial tests

NA trial testing Axillary plexus nerve block in Distal Radius Fracture in 117 participants. Completed in 28 November 2023.

Timeline

1 July 2021

Primary endpoint
28 November 2023

28 November 2023

Quick facts

Lead sponsor	Frisius Medisch Centrum
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	117
Start date	1 July 2021
Primary completion	28 November 2023
Estimated completion	28 November 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Axillary plexus nerve block
• Fracture hematoma block

Conditions studied

• Distal Radius Fracture — all drugs for Distal Radius Fracture →
• Forearm Fracture — all drugs for Forearm Fracture →

Sponsor

Frisius Medisch Centrum — full company profile →

Who can join

16 and older, any sex, with Distal Radius Fracture or Forearm Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.