Spinal morphine in patients with hip fractures to reduce delirium

Phase 4

Completed

Conditions: delirium
hip fracture
10014623
10012221
10005944

Registration Number: NL-OMON54044

Lead Sponsor: Maasstadziekenhuis

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of delirium during hospital admission</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are<br /><br>o Delirium Observation Screening Scale (DOSS)-scores (three times daily),<br /><br>o pain scores on a Numeric Rating Scale (NRS),<br /><br>o post-operative opioid consumption,<br /><br>o post-operative consumption of ondansetron for nausea or pruritus,<br /><br>o Patient questionnaire with the Quality of Recovery-15 on POD 1 (including<br /><br>subscales),<br /><br>o Pruritus-severity score on POD 1,<br /><br>o time of mobilization after surgery,<br /><br>o occurrence of complications such as infections, cerebrovascular disorders,<br /><br>respiratory insufficiency and myocardial injury,<br /><br>o mortality,<br /><br>o discharge facility,<br /><br>o length of hospital stay.<br /><br>Tertiary outcome is the serum level of NFL on the second post-operative day.</p><br>