The main objective is to decrease the incidence of delirium in patients receiving surgical treatment of a proximal femur fracture with spinal anesthesia.
ID
Source
Brief title
Condition
- Encephalopathies
- Deliria (incl confusion)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of delirium during hospital admission
Secondary outcome
Secondary outcomes are
o Delirium Observation Screening Scale (DOSS)-scores (three times daily),
o pain scores on a Numeric Rating Scale (NRS),
o post-operative opioid consumption,
o post-operative consumption of ondansetron for nausea or pruritus,
o Patient questionnaire with the Quality of Recovery-15 on POD 1 (including
subscales),
o Pruritus-severity score on POD 1,
o time of mobilization after surgery,
o occurrence of complications such as infections, cerebrovascular disorders,
respiratory insufficiency and myocardial injury,
o mortality,
o discharge facility,
o length of hospital stay.
Tertiary outcome is the serum level of NFL on the second post-operative day.
Background summary
Surgical treatment of proximal femur fractures is complicated by a high
incidence of post-operative delirium. Many contributing factors have been
identified, most of them are non-modifiable. However, pain and opioid
consumption are modifiable factors which may lead to a lower incidence of
delirium. An intrathecal injection of morphine may lead to both a reduction in
postoperative pain and a reduced opioid consumption. In common practice, the
addition of morphine to the spinal anesthesia is commonly used, but depends on
the preference of the anesthesiologist. Recently, a retrospective study found
that the use of intrathecal morphine was independently associated with a lower
incidence of delirium. This has to be confirmed in a prospective study.
Study objective
The main objective is to decrease the incidence of delirium in patients
receiving surgical treatment of a proximal femur fracture with spinal
anesthesia.
Study design
A double-blinded, placebo-controlled, randomized study.
Intervention
The addition of 100 mcg morphine to the intrathecal injection for spinal
anesthesia.
Study burden and risks
The burden constitutes of a questionnaire on day 1 and a blood sample at day 2
to determine the NFL-levels. All other outcome measures are routinely obtained
in clinical practise. Spinal anesthesia is the preferred method of anesthesia
for these patients in the study hospital.
The risks of receiving intrathecal morphine (intervention group treatment) are
a higher incidence of pruritus, nausea, urinary-rentention and a late
respiratory depression. Prophylactic measures are installed for pruritus and
nausea, which will limit the incidence and severity. All patients will receive
a urinary-catheter, which solves the consequences of urinary retention. Late
respiratory depression has not been reported with a low dose of intrathecal
morphine (<500 mcg). Interaction with routinely administered systemic opioids
or benzodiazepines could enhance this complication, and these medications are
prohibited on the night after surgery.
korenschoofstraat 173
Utrecht 3513 DE
NL
korenschoofstraat 173
Utrecht 3513 DE
NL
Listed location countries
Age
Inclusion criteria
Proximal femur fracture
Scheduled for surgerical treatment
Spinal anesthesia
Exclusion criteria
Contraindications for spinal anesthesia:
- Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine
(>100 aXa-IE/kg) or heparine (APTT> 30 sec), recent use of a Direct Oral
Anticoagulant, as stated in the guideline *Neuraxisblokkade en antistolling* by
the Dutch Society of Anesthesiology.
- Aortic Valve Stenosis of AVA < 1.0 cm2
- Lumbar malformations (local inflammation, lumbar osteosynthesis material,
meningocele, tethered cord)
- Inability to retrieve cerebrospinal fluid by lumbar puncture.
Contra-indications for intrathecal morphine:
- Chronic opioid or benzodiazepine use (>1 month daily use).
Other:
- Allergies to amide-type local anesthetics and morphine.
- Patients* refusal
- Patients who are incapable of making decisions regarding anesthesia and no
legal representative is available.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002143-27-NL |
| CCMO | NL73950.100.20 |
| OMON | NL-OMON27635 |