An interventional study of Axillary plexus nerve block and Fracture hematoma block in Distal Radius Fracture and Forearm Fracture, sponsored by Frisius Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Frisius Medisch Centrum · Not applicable, Interventional, and Treatment
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.
329 studies on the registry are indexed under Wrist Fractures; 69 are open to participants now.
This study's enrollment of 117 is above the median of 63 across 267 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Frisius Medisch Centrum is the lead sponsor of 6 studies on the registry; none are open to participants now.
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The intervention group will receive an axillary plexus nerve block as pain reduction before the fracture repositioning.
Procedure: Axillary plexus nerve block
The control group will receive a fracture hematoma block as pain reduction before the fracture repositioning.
Procedure: Fracture hematoma block
Axillary plexus nerve block: an ultrasound-guided axillary plexus nerve block with a single injection of lidocaine 1%.
Fracture hematoma block: a blinded single injection into the fracture with lidocaine 1%.
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
Time frame: 15 minutes
Plan to share: No
Ran from Jul 2021 to primary completion in Nov 2023, 28 months.
Of 120 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's 28 months is close to that.
Counting every sponsor, half of 121 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Frisius Medisch Centrum