The objective of this study is to determine the clinical outcomes of ultrasound guided axillary nerve block using prilocaine, in patients with distal radius fractures and compare these results to patients treated with a ultrasound guided cubital…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives of this study are to investigate whether axillary nerve
block leads to a decrease in pain compared to control patients. This will be
measured through a raw pain intensity difference (PID) using visual analogue
pain score after fracture reduction.
Secondary outcome
The secondary parameters of this study includes pain measured in rest, during
physical examination, after the analgesia procedure, after fracture reduction,
after plaster cast application, after control radiograph, secondary loss of
reduction measured on plain radiographs.
Background summary
Distal radius fractures are commonly diagnosed in emergency departments. These
fractures are often treated conservatively through fracture reduction and cast
immobilization. Pain reduction during this procedure is achieved through
injection of a local anaesthetic into the fracture hematoma. Recently, we
showed that a peripheral nerve block around the elbow provides more superior
analgesia compared to the standard hematoma block However, these patients were
still not pain free. Possibly, this results of inadequate treatment of the
musculocutaneous nerve. We therefore propose to study the effect of a axillary
nerve block after a distal radius fracture compared to the cubital nerve block.
Study objective
The objective of this study is to determine the clinical outcomes of ultrasound
guided axillary nerve block using prilocaine, in patients with distal radius
fractures and compare these results to patients treated with a ultrasound
guided cubital nerve block.
Study design
Patients admitted to the Reinier de Graaf Hospital*s emergency department with
radiographic proven distal radius fracture in need of reduction, will be
included in this randomized controlled trial. Participants will be randomized
into one of two arms: cubital nerve block with prilocaine or axillary nerve
block with prilocaine. Patient will be included into the study immediately
after radiographic confirmation of the distal radius fracture in need of
reduction.
Intervention
The study group will receive a axillary nerve block using 30ml (300 mg)
prilocaine. The control group will receive a cubital nerve block using 20ml
(200 mg) prilocaine.
Study burden and risks
Our previous study concluded that a cubital nerve block provokes less pain in
distal radius fracture reduction. Since the musculocutaneous nerve is not
anaesthetized with this technique, patients treated with axillary nerve block
are likely to suffer even less pain, and as a result might have a more optimal
outcome in fracture healing as well. Patients included in this study will risk
complications associated with cubital or axillary nerve blockage. These
complication rates are low and usually self-limiting in the first days.
Possibly, patients in the intervention group might show reduced numbers of
chronic regional pain syndrome (CRPS) development. The number of out-patient
clinic visits is the same as for non-participating patients.
Reinier de Graafweg 3
Delft 2625 AD
NL
Reinier de Graafweg 3
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Proven dislocated distal radius (simple or multifragmentary, intra-articular or extra-articular fractures) requiring closed reduction
Normal upper extremity anatomy and neurovascular examination
Aged 18-years or older
Patients eligible for primary surgical fracture fixation
Exclusion criteria
Inability to perform the NRS for pain (eg due to delirium, or cognitive impairment)
No good understanding of the Dutch language
Multi-trauma patients
Hypersensitivity to prilocaine and/or PABA (preservative agent in Citanest)
Methemoglobinaemie
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59513.098.16 |