The objective of this study is to determine the clinical outcomes of ultrasound guided cubital nerve blockage using prilocaine, in patients with distal radius fractures and compare these results to patients treated with a fracture hematoma block.
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 cubital nerve
blockage 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 after the
analgesia procedure, after fracture reduction, 15 and 30 minutes after
reduction, need for re-reduction, secondary loss of reduction measured on plain
radiographs. 1,4 and 12 weeks after fracture reduction, the patient will visit
the outpatient clinic (standard care).
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. However, the
extent of functional pain management of this technique remains arguable. We
therefore propose to study the effect of a cubital nerve block after a distal
radius fracture compared to a conventional fracture hematoma block.
Study objective
The objective of this study is to determine the clinical outcomes of ultrasound
guided cubital nerve blockage using prilocaine, in patients with distal radius
fractures and compare these results to patients treated with a fracture
hematoma 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 single-blinded randomized controlled trial. Participants will
be randomized into one of two arms: cubital nerve block with prilocaine or
local injection prilocaine into the fracture hematoma. 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 cubital nerve block using 5ml prilocaine. The
control group will receive a local injection into the fracture hematoma with
10ml prilocaine.
Study burden and risks
As suggested in previous studies using Bier*s block, patients treated with
cubital nerve blockage are likely to suffer 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 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 5
Delft 2625 AD
NL
Reinier de Graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Dislocated distal radius fracture in need of closed reduction
Normal anatomy and neurovascular examination upper extremity
Aged 18 years or older
Exclusion criteria
Cognitive impairment
On-going delirium at inclusion
No good understanding of the Dutch language
Multi-trauma patients
Known hypersensitivity to local anaesthetics
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL56606.098.16 |