Percentage of accurate guessed blocks
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
analgesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in pain during immobilisation by using the visual analogue scale 60
minutes after block placement.
Secondary outcome
- Accordance between preceived block and guessed block by the patient
- Time of maximum pain reduction after block placement
- De difference in VAS reduction during dynamic and static exam after block
placement
- Side effects of the fascia iliaca compartment block (infection, hematoma,
sensibility disorder, allergic reactions)
Background summary
Hip and femur fractures are common. These patients experience a lot of pain.
Sufficient analgesia may be given by systemic administered paracetamol, NSAIDS,
opiates and regional nervous blockade. A fascia iliaca compartment block, a
FICB, is a form of regional anesthesia that can reduce the femoral nerve,
lateral cutaneous nerve and (possible) obturator nerve. Onset after successful
placement of the block with levobupivacaine is 15-30 minutes and last up to 12
hours. The advantage of a block is that no or lower amounts of systemic opiates
need to be given. An FICB can be placed ultrasound guided or according to the
landmark method. The literature states that a FICB can be used safely and
efficiently, and there are almost no complications registered with only minor
local side effects. It is also a technique that can be easily learned.
However, in the current investigations, various methods, times after FICB
placement and outcomes are described, making this research difficult to
generalize, and difficult to use for calculating power for a new study. In
addition, blindering of patients and outcome assessors did not take place in
earlier studies. This may have led to distorted outcomes of those studies. Both
the landmark method and the echo-guided method are applied within the Isala.
These two methods have not previously been investigated side by side with
respect to reduction in pain score expressed from 0 to 100 mm on a visual
analog scale (VAS). We want to investigate with this pilot study the ability to
test these methods double-blind, to also see which moment after the block can
be used (both methods) for the primary pain reduction (pre and post block) and
a better estimation of the reduction in pain between both methods, so that an
RCT could possibly be done in the future to compare the efficiency between the
two methods.
Study objective
Percentage of accurate guessed blocks
Study design
Randomised double blinded pilot study
Intervention
Group 1: Fascia iliaca compartment block with landmark methode
Group 2: Ultrasound guided fascia iliaca compartment block
Study burden and risks
There is no added burden. Possible risks are infection, hematoma and allergic
reactions.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Adults
- Hip fracture
Exclusion criteria
- Allergy for levobupivacaïne
- Infection at injection site
- INR > 1,5
- Previous femoral vascular surgery at fracture site
- Non-cooperative patient and reduced level of consciousness
Design
Recruitment
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 |
|---|---|
| EudraCT | EUCTR 2016-003605-3-NL |
| CCMO | NL59101.075.16 |