We hypothesize that the use of intrathecal morphine reduces postoperative pain and opioid consumption, which in turn will reduce the incidence of delirium.
ID
Bron
Verkorte titel
Aandoening
Proximal femur fracture, delirium
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of postoperative delirium during hospital admission, defined according to the DSM-5 criteria
Achtergrond van het onderzoek
Delirium complicates surgical treatment for proximal femur fractures in 20-50% of the patients. Many modifiable and non-modifiable risk factors are identified. Two modifiable risk factors are opioid consumption and pain, both of which are reduced with the use of intrathecal morphine. Therefore, a randomized controlled trial is designed to investigate if the addition of intrathecal morphine to spinal anesthesia reduces the incidence of delirium after surgical treatment for proximal femur fractures.
Doel van het onderzoek
We hypothesize that the use of intrathecal morphine reduces postoperative pain and opioid consumption, which in turn will reduce the incidence of delirium.
Onderzoeksopzet
Day of admission:
- Baseline characteristics (such as pre-existing cognitive impairment and serum Neurofilament Light concentration (n=80))
Anesthesia and surgery
- Time to surgery, duration of surgery, type of surgery, estimated bloodloss
- Use of sedation during surgery, conversion to general anesthesia.
Post-operative day 1:
- QoR-15
- Pruritus severity score
- Ondansetron consumption
Post-operative day 2:
- Neurofilament light serum concentration (in a subset of the patients (n=80)).
- Ondansetron consumption
During hospital admission:
- The incidence of delirium, as measured with DSM-5 criteria
- Post-operative opioid consumption
- Time to mobilization after surgery
- Occurence of complications
- Time to fit-for-discharge
- Length of hospital stay.
During the first 5 postoperative days:
- The mean DOSS-scores
- The mean pain-scores
After discharge:
- Discharge facility
- 30 day-mortality
Onderzoeksproduct en/of interventie
Both arms will receive the same preoperative analgesic management, consisting of paracetamol, metamizol (if no contra-indications), a preoperative regional nerve block as soon as possible and opioids if necessary.
Patients will be randomized for the intervention group (receiving 10 mg bupivacaine + 100 mcg morphine in 4 ml) and the control group (receiving 10 mg bupivacaine in 4 ml) for spinal anesthesia. Postoperative analgesic management consists of paracetamol, metamizol (if no contra-indications) and opioids if necessary for both arms.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Femur fracture
- Scheduled for surgery
- Spinal anesthesia
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for spinal anesthesia:
o Patients’ refusal
o Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg), 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).
o Aortic Valve Stenosis of AVA < 1.0 cm2
o Lumbar malformations (local inflammation, lumbar osteosynthesis material, meningocele, tethered cord)
- Inability to retrieve cerebrospinal fluid by lumbar puncture.
- Contra-indications for intrathecal morphine:
o Chronic opioid or benzodiazepine use (>1 month daily use).
- Allergies to amide-type local anesthetics and morphine.
- Patients who are incapable of making decisions regarding anesthesia and no legal representative is available.
Opzet
Deelname
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Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9390 |
| CCMO | NL73950.100.20 |
| OMON | NL-OMON54044 |