The primary objective of this study is to compare the efficacy of ultrasound-guided fascia iliaca block (FICB) to standard treatment with parenteral opioids for pain control in patients with hip fractures in the emergency department. Is there a…
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
pijnstilling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study:
patient reported pain scores, ranging from 0 (no pain) to 10 (worst pain
imaginable)
Secondary outcome
Secundary outcome of the study:
- side effects/complications
- period of time spending at the emergency department until adequate pain
reduction (pain score <= 4)
- proportion successful FICB
- patients experience
Background summary
Annual, about 350 patients present at the emergency department of the Sint
Franciscus Gasthuis with a painful hip fracture.
Patients who experience pain from hip fracture are often treated with
intravenous opiates, which may cause deleterious side effects, particularly in
elderly patients.
An alternative to systemic opioid analgesia involves peripheral nerve blockade.
Multiple studies concluded that the fascia iliaca compartment block (FICB) is a
fast , safe and effective method of providing pain relief to patients with
fracture of the femur. After a successful block, the subsequent requirement of
opioids is reduced which avoids potential side effects such as nausea, vomiting
delirium and respiratory depression, especially in elderly patients. This
approach may be ideally suited for the ED environment, where one injection
could control pain for many hours.
In Sint Franciscus Gasthuis the current practice for pain relief in patients
with fracture of the femur is still opioids.
Study objective
The primary objective of this study is to compare the efficacy of
ultrasound-guided fascia iliaca block (FICB) to standard treatment with
parenteral opioids for pain control in patients with hip fractures in the
emergency department.
Is there a significant reduction in pain between arrival and departure of the
emergency department in patients with femur fracture that were treated by
ultrasound-guided femoral nerve block? Is there a significant reduction in pain
when patients received parenteral opioids?
Secundary objectives:
1. incidence of side effects in parenteral opioids vs FICB
2. percentage successful FICB
3. duration of adequate pain relief in FICB vs parenteral opiods
4. patients experience of FICB vs parenteral opiods
5. effectiveness of FICB given by an ED doctor vs resident emergency medicine
Study design
single center randomized controlled trial
Intervention
intervention: ultrasound -guided fascia iliaca compartment block using
bupivacaine as an anesthetic. Control strategy: parenteral opioids.
Patients who are not able to consent and patients who do not meet all inclusion
criteria (or meet one of the exclusion criteria) received standard care:
parenteral opioids.
Study burden and risks
Overall a FICB has a very low risk profile, besides local hematoma and redness
around the injection side.
The location of the FICB injection means the risk of intravascular injection,
local anaesthetic toxicity, and mechanical nerve damage is extremely low. The
technique will be performed under ultrasound-guidance, mimimalising the risk
even further.
There is a antidote protocol available at the emergency department.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
(1) patients presenting at the emergency department between 08:00 and 23:00 hr.
(2) patients with a radiographically proven hip fracture
(3) patients aged 18 years and older
(4) informed consent
Exclusion criteria
(1) open fractures
(2) femoral nerve injury
(3) Inflammation or infection over injection site
(4) known international normalized ratio > 4.5
(5) prior femoral artery vascular surgery on the same side as the fracture
(6) known hypersensitivity to local anesthetics or morphine
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 |
---|---|
CCMO | NL47789.101.14 |